## Protocol Section
### Identification Module
**NCT ID:** NCT01506479

**Acronym:** SPARX

**Brief Title:** Study in Parkinson's Disease of Exercise

**Official Title:** Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease

#### Organization Study ID Info
**ID:** 11-1237
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
#### Secondary ID Infos
**ID:** R01NS074343
**Link:** https://reporter.nih.gov/quickSearch/R01NS074343
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-10-13

**Type:** ACTUAL

**Last Update Submit Date:** 2017-09-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-10-13

**Type:** ACTUAL

**Results First Submit Date:** 2017-06-23

**Results First Submit QC Date:** 2017-09-12

#### Start Date
**Date:** 2012-05

**Type:** ACTUAL

**Status Verified Date:** 2017-09

#### Study First Post Date
**Date:** 2012-01-10
**Type:** ESTIMATED
**Study First Submit Date:** 2011-12-16
**Study First Submit QC Date:** 2012-01-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Illinois at Chicago

**Class:** OTHER

**Name:** University of Pittsburgh

**Class:** OTHER

**Name:** Rush University Medical Center

**Class:** NIH

**Name:** National Institute of Neurological Disorders and Stroke (NINDS)

**Class:** OTHER

**Name:** Northwestern University

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Colorado, Denver

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.

**Detailed Description:** The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.

### Conditions Module

**Conditions:**

- Parkinson Disease

**Keywords:**

- Parkinson Disease

- Basal Ganglia Disease

- Central Nervous System Diseases

- Nervous System Diseases

- Movement Disorders

- Neurodegenerative Diseases

- Brain Diseases

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 128

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise.

**Intervention Names:**

- Behavioral: No Intervention

**Label:** Control Group

**Type:** SHAM_COMPARATOR

#### Arm Group 2

**Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

**Intervention Names:**

- Behavioral: Vigorous Exercise

**Label:** Vigorous Exercise

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

**Intervention Names:**

- Behavioral: Moderate Exercise

**Label:** Moderate Exercise

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Moderate Exercise

**Description:** Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.

**Name:** Moderate Exercise

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Vigorous Exercise

**Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

**Name:** Vigorous Exercise

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Control Group

**Description:** No-exercise control (i.e., usual care);

**Name:** No Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** The number of days the participant exercised per week

**Measure:** Number of Days of Exercise Per Week

**Time Frame:** 9 to 26 weeks

#### Primary Outcomes

**Description:** To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.

**Measure:** Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise

**Time Frame:** 9 to 26 weeks

#### Secondary Outcomes

**Description:** Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.

**Measure:** 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score

**Time Frame:** Baseline and 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Clinical diagnosis of primary Parkinson's disease
* In a Hoehn and Yahr stage less than stage III
* Disease duration is less than 5 years
* Not likely to require dopaminergic therapy within 6 months

Exclusion Criteria:

* Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
* Duration of previous use of medications for PD that exceeds 90 days
* Expected to require dopaminergic therapy in the next 6 months
* Poorly controlled or unstable cardiovascular disease
* Uncontrolled hypertension
* Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function
* Mild cognitive impairment (Montreal Cognitive Assessment score\<26/30)
* Depression that precludes ability to exercise (Beck depression score\>13)
* Disorders that interfere with ability to perform endurance exercises
* Regular participation in vigorous endurance exercise
* Evidence of serious arrhythmias or ischemic heart disease
* Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aurora

**Country:** United States

**Facility:** University of Colorado Denver

**State:** Colorado

**Zip:** 80045

**Location 2:**

**City:** Chicago

**Country:** United States

**Facility:** University of Illinois, Chicago

**State:** Illinois

**Zip:** 60612

**Location 3:**

**City:** Pittsburgh

**Country:** United States

**Facility:** University of Pittsburgh

**State:** Pennsylvania

**Zip:** 15213

#### Overall Officials

**Official 1:**

**Affiliation:** University of Colorado, Denver

**Name:** Margaret Schenkman, PT, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Illinois at Chicago

**Name:** Daniel Corcos, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Hall DA, Moore C, Comella C; SPARX Study Group. Recruitment of patients with de novo Parkinson disease: successful strategies in a randomized exercise clinical trial. Trials. 2018 Nov 14;19(1):630. doi: 10.1186/s13063-018-2958-z.

**PMID:** 30428907

**Citation:** Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.

**PMID:** 29228079

**Citation:** Moore CG, Schenkman M, Kohrt WM, Delitto A, Hall DA, Corcos D. Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Contemp Clin Trials. 2013 Sep;36(1):90-8. doi: 10.1016/j.cct.2013.06.002. Epub 2013 Jun 14.

**PMID:** 23770108

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Control Group

**Deaths Num At Risk:** 40

**Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise.

No Intervention: No-exercise control (i.e., usual care);

**ID:** EG000

**Other Num Affected:** 13

**Other Num at Risk:** 40

**Serious Number At Risk:** 40

**Title:** Control Group

**Group ID:** EG001

**Title:** Vigorous Exercise

**Deaths Num At Risk:** 43

**Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

**ID:** EG001

**Other Num Affected:** 28

**Other Num at Risk:** 43

**Serious Number At Risk:** 43

**Title:** Vigorous Exercise

**Group ID:** EG002

**Title:** Moderate Exercise

**Deaths Num At Risk:** 45

**Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.

**ID:** EG002

**Other Num Affected:** 24

**Other Num at Risk:** 45

**Serious Number Affected:** 2

**Serious Number At Risk:** 45

**Title:** Moderate Exercise

**Frequency Threshold:** 0

#### Other Events

**Term:** Blood and lymphatic system disorders - Other, specify

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Gastric ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Gastrointestinal disorders - Other, specify

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Flu like symptoms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Flu like symptoms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Bladder infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Lung infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Rhinitis infective

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Skin infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Upper respiratory infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** CTCAE (4.0)

**Term:** Injury, poisoning and procedural complications - Other, specify

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** CTCAE (4.0)

**Term:** Injury, poisoning and procedural complications - Other, specify

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** CTCAE (4.0)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Buttock pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTCAE (4.0)

**Term:** Nervous system disorders - Other, specify

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Renal calculi

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Urine discoloration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Sore throat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Skin and subcutaneous tissue disorders - Other, specify

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Surgical and medical procedures - Other, specify

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (4.0)

#### Serious Events

**Term:** Renal calculi

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 40

**Group ID:** EG001

**Num At Risk:** 43

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 45

**Num Events:** 1

**Term:** Gastric ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 40

**Group ID:** EG001

**Num At Risk:** 43

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 45

**Num Events:** 1

**Time Frame:** Adverse event data were collected monthly until the primary time point at 6 months.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 40

**Group ID:** BG001

**Value:** 43

**Group ID:** BG002

**Value:** 45

**Group ID:** BG003

**Value:** 128

**Units:** Participants

### Group

**ID:** BG000

**Title:** Control Group

**Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise.

No Intervention: No-exercise control (i.e., usual care);

### Group

**ID:** BG001

**Title:** Vigorous Exercise

**Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

### Group

**ID:** BG002

**Title:** Moderate Exercise

**Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10

**Value:** 64

#### Measurement

**Group ID:** BG001

**Spread:** 9

**Value:** 64

#### Measurement

**Group ID:** BG002

**Spread:** 10

**Value:** 63

#### Measurement

**Group ID:** BG003

**Spread:** 9

**Value:** 64

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 40

**Group ID:** BG001

**Value:** 43

**Group ID:** BG002

**Value:** 45

**Group ID:** BG003

**Value:** 128

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 18

#### Measurement

**Group ID:** BG003

**Value:** 55

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 24

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 27

#### Measurement

**Group ID:** BG003

**Value:** 73

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 40

**Group ID:** BG001

**Value:** 43

**Group ID:** BG002

**Value:** 45

**Group ID:** BG003

**Value:** 128

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 6

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 39

#### Measurement

**Group ID:** BG002

**Value:** 41

#### Measurement

**Group ID:** BG003

**Value:** 119

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 3

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 40

**Group ID:** BG001

**Value:** 43

**Group ID:** BG002

**Value:** 45

**Group ID:** BG003

**Value:** 128

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 6

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 5

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 39

#### Measurement

**Group ID:** BG002

**Value:** 40

#### Measurement

**Group ID:** BG003

**Value:** 115

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 40

**Group ID:** BG001

**Value:** 43

**Group ID:** BG002

**Value:** 45

**Group ID:** BG003

**Value:** 128

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7

**Value:** 17

#### Measurement

**Group ID:** BG001

**Spread:** 7

**Value:** 17

#### Measurement

**Group ID:** BG002

**Spread:** 7

**Value:** 16

#### Measurement

**Group ID:** BG003

**Spread:** 7

**Value:** 17

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 40

**Group ID:** BG001

**Value:** 43

**Group ID:** BG002

**Value:** 45

**Group ID:** BG003

**Value:** 128

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2987

**Value:** 5005

#### Measurement

**Group ID:** BG001

**Spread:** 3107

**Value:** 5146

#### Measurement

**Group ID:** BG002

**Spread:** 2521

**Value:** 5702

#### Measurement

**Group ID:** BG003

**Spread:** 2856

**Value:** 5306

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 36

**Group ID:** BG001

**Value:** 36

**Group ID:** BG002

**Value:** 42

**Group ID:** BG003

**Value:** 114

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 13

#### Measurement

**Group ID:** BG003

**Value:** 33

**Category Title:** Stage 1

#### Measurement

**Group ID:** BG000

**Value:** 32

#### Measurement

**Group ID:** BG001

**Value:** 31

#### Measurement

**Group ID:** BG002

**Value:** 32

#### Measurement

**Group ID:** BG003

**Value:** 95

**Category Title:** Stage 2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 40

**Group ID:** BG001

**Value:** 43

**Group ID:** BG002

**Value:** 45

**Group ID:** BG003

**Value:** 128

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Description:** Sum of 27 items scored 0 to 4, minimum score is 0, maximum score is 108. Higher score indicates worse motor symptoms.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Unified Parkinson Disease Rating Scale Part 3 Motor Evaluation
**Unit of Measure:** units on a scale
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Several participants did not wear the activity monitor devices for recording total number of daily steps.
**Title:** Total daily steps
**Unit of Measure:** steps per day
### Measure 7
**Description:** Stage 1 is Unilateral Disease; Stage 2 is Bilateral Disease without impairment of balance
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Hoehn and Yahr Stage
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** cgp22@pitt.edu
**Organization:** University of Pittsburgh
**Phone:** 412-383-6630
**Title:** Dr. Charity G. Moore
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 12.0
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 16.6
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.3
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** ONE_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 4.6
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 0.34
**P-Value Comment:** The a priori threshold for statistical significance was 0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 2.9
**Statistical Comment:** 
**Statistical Method:** t-test, 1 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** ONE_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 2.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The estimate is the difference between the control group and the moderate exercise group.

The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis.
**Group Description:** The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation .
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 0.03
**P-Value Comment:** The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 1.2
**Statistical Comment:** 
**Statistical Method:** t-test, 1 sided
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1334
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 78.8
- **Spread:** 
- **Upper Limit:** 81.7
- **Value:** 80.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 64.2
- **Spread:** 
- **Upper Limit:** 67.7
- **Value:** 65.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.4
- **Spread:** 
- **Upper Limit:** 5.1
- **Value:** 3.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.7
- **Spread:** 
- **Upper Limit:** 2.3
- **Value:** 0.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.4
- **Spread:** 
- **Upper Limit:** 3.7
- **Value:** 2.0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.4
- **Spread:** 
- **Upper Limit:** 3.2
- **Value:** 2.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.8
- **Spread:** 
- **Upper Limit:** 3.6
- **Value:** 3.2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Only for participants who contributed heart rate monitor data.
**Reporting Status:** POSTED
**Time Frame:** 9 to 26 weeks
**Title:** Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise
**Type:** PRIMARY
**Unit of Measure:** percentage of maximum heart rate
##### Group
**Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
**ID:** OG000
**Title:** Vigorous Exercise
##### Group
**Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
**ID:** OG001
**Title:** Moderate Exercise
#### Outcome Measure 2
**Description:** Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Intention to treat; participants were analyzed in the group to which they were assigned. If a participant started medication, the UPDRS measure prior to initiating medication was used even if the 6 month data were not collected. Participants who did not start medications and were missing the 6 month assessment were not included.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 6 months
**Title:** 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
**Type:** SECONDARY
**Unit of Measure:** units on the UPDRS Motor scale
##### Group
**Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise.

No Intervention: No-exercise control (i.e., usual care);
**ID:** OG000
**Title:** Control Group
##### Group
**Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
**ID:** OG001
**Title:** Vigorous Exercise
##### Group
**Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
**ID:** OG002
**Title:** Moderate Exercise
#### Outcome Measure 3
**Description:** The number of days the participant exercised per week
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants were analyzed in the group to which they were assigned. Participants were not included if they did not start the intervention.
**Reporting Status:** POSTED
**Time Frame:** 9 to 26 weeks
**Title:** Number of Days of Exercise Per Week
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Number of days per week
##### Group
**Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
**ID:** OG000
**Title:** Vigorous Exercise
##### Group
**Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
**ID:** OG001
**Title:** Moderate Exercise
### Participant Flow Module
#### Group
**Description:** Wait listed to moderate or vigorous exercise after 6 months of no exercise.

No Intervention: No-exercise control (i.e., usual care);
**ID:** FG000
**Title:** Control Group
#### Group
**Description:** Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
**ID:** FG001
**Title:** Vigorous Exercise
#### Group
**Description:** Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
**ID:** FG002
**Title:** Moderate Exercise
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Missing assessment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 40
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 43
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 45
##### Milestone
**Type:** COMPLETED
**Comment:** Number of participants with 6 month follow-up.
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 42
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 3
**Pre-Assignment Details:** Screening included confirmation of Parkinson disease diagnosis, assessment of depression and cognition, testing for laboratory measures, and testing for blood pressure and echocardiogram responses to exercise during graded exercise. Once deemed eligible, baseline assessments were completed for disease and non-disease specific scales.
**Recruitment Details:** Prescreening by telephone and for patients in movement disorder clinics from May 2012 to November 2015.
**Has Results:** True