## Protocol Section
### Identification Module
**NCT ID:** NCT01113879

**Brief Title:** Exercise as an Adjuvant to Aphasia Therapy

**Official Title:** Exercise as an Adjuvant to Aphasia Therapy

#### Organization Study ID Info
**ID:** C7175-M
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2012-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-07-22

**Type:** ACTUAL

**Last Update Submit Date:** 2019-05-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-07-22

**Type:** ACTUAL

**Results First Submit Date:** 2019-05-03

**Results First Submit QC Date:** 2019-05-03

#### Start Date
**Date:** 2009-07

**Type:** ACTUAL

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2010-04-30
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-28
**Study First Submit QC Date:** 2010-04-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Brooks Rehabilitation

#### Lead Sponsor

**Class:** FED

**Name:** VA Office of Research and Development

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the study is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities than patients who do not participate in aerobic activity.

**Detailed Description:** The objective of this research project is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities with treatment than patients who do not participate in aerobic activity. As secondary objectives, we will determine if there is a direct relationship between either brain efficiency or increases in Brain Derived Neurotrophic Factor (BDNF) after exercise and higher learning rates in aphasia.

### Conditions Module

**Conditions:**

- Aphasia

**Keywords:**

- rehabilitation

- aphasia

- exercise

- BDNF

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The study used a single-subject, multiple-baseline design across behaviors. Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus aerobic exercise or stretching.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.

**Intervention Names:**

- Behavioral: Aerobic exercise

**Label:** Aphasia therapy with an exercise adjuvant

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.

**Intervention Names:**

- Behavioral: Stretching

**Label:** Aphasia therapy with a stretching adjuvant

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Aphasia therapy with an exercise adjuvant

**Description:** An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.

**Name:** Aerobic exercise

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Aphasia therapy with a stretching adjuvant

**Description:** Stretching will occur for 50 minutes a day, three days/week for 12 weeks.

**Name:** Stretching

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Tau-U effect sizes of \<0.20 were considered small; 0.20 to \<0.60 moderate; 0.60 to \<0.80 large, and \>=0.80 very large. Weighted Tau-U averages in exercise participants and stretching participants were calculated in each block using an online web-based calculator (http://www.singleresearch.org/calculators/tau-u). In the present analysis, any baseline trends over 0.10 were adjusted.

**Measure:** Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means

**Time Frame:** administered before and after each of two, two week aphasia therapy blocks

#### Secondary Outcomes

**Description:** The baseline BDNF levels in participants (ie, the 2 measures prior to the exercise or stretching interventions) showed a great deal of intraparticipant variation. Hence, in an attempt to minimize the intraparticipant variability, we calculated the mean values from samples 1 and 2 to obtain a baseline BDNF measure, samples 3 and 4 to obtain a BDNF measure in the first 6 weeks of aerobic exercise or stretching, and samples 5 and 6 to obtain a measure in the last 6 weeks of the exercise or stretching intervention.

**Measure:** Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise

**Time Frame:** six samples collected over a 16 week period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Post-stroke aphasia
* at least 6 months post-stroke
* at least minimally intact auditory verbal comprehension
* pre-morbidly right handed
* native English speaker

Exclusion Criteria:

* contraindications for fMRI (metal implants, claustrophobia)
* inability to pass an exercise tolerance test
* significant depression
* uncorrected hearing or vision problems
* severe apraxia of speech
* regularly perform 20 minutes of cardiovascular exercise 3 times per week

**Maximum Age:** 95 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gainesville

**Country:** United States

**Facility:** North Florida/South Georgia Veterans Health System

**State:** Florida

**Zip:** 32608

**Location 2:**

**City:** Jacksonville

**Country:** United States

**Facility:** Brooks Rehabilitation Clinical Research Center

**State:** Florida

**Zip:** 32216

#### Overall Officials

**Official 1:**

**Affiliation:** North Florida/South Georgia Veterans Health System

**Name:** Stacy M. Harnish, PhD CCC/SLP

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Harnish SM, Rodriguez AD, Blackett DS, Gregory C, Seeds L, Boatright JH, Crosson B. Aerobic Exercise as an Adjuvant to Aphasia Therapy: Theory, Preliminary Findings, and Future Directions. Clin Ther. 2018 Jan;40(1):35-48.e6. doi: 10.1016/j.clinthera.2017.12.002. Epub 2017 Dec 23.

**PMID:** 29277374

#### See Also Links

**Label:** Click here for more information about this study: Exercise as an Adjuvant to Aphasia Therapy

**URL:** http://www.brrc.research.va.gov

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013064

- Term: Speech Disorders

- ID: D000007806

- Term: Language Disorders

- ID: D000003147

- Term: Communication Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4352

- Name: Aphasia

- Relevance: HIGH

- As Found: Aphasia

- ID: M15864

- Name: Speech Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10823

- Name: Language Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6374

- Name: Communication Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001037

- Term: Aphasia

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Aphasia Therapy With an Exercise Adjuvant

**Deaths Num At Risk:** 5

**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.

**ID:** EG000

**Other Num at Risk:** 5

**Serious Number At Risk:** 5

**Title:** Aphasia Therapy With an Exercise Adjuvant

**Group ID:** EG001

**Title:** Aphasia Therapy With a Stretching Adjuvant

**Deaths Num At Risk:** 2

**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.

**ID:** EG001

**Other Num at Risk:** 2

**Serious Number At Risk:** 2

**Title:** Aphasia Therapy With a Stretching Adjuvant

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 7

**Group ID:** BG001

**Value:** 2

**Group ID:** BG002

**Value:** 9

**Units:** Participants

### Group

**ID:** BG000

**Title:** Aphasia Therapy With an Exercise Adjuvant

**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.

### Group

**ID:** BG001

**Title:** Aphasia Therapy With a Stretching Adjuvant

**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.5

**Value:** 63.2

#### Measurement

**Group ID:** BG001

**Spread:** 10.6

**Value:** 44.5

#### Measurement

**Group ID:** BG002

**Spread:** 14.4

**Value:** 57.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 9

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 10

**Upper Limit:** 43

**Value:** 20.6

#### Measurement

**Group ID:** BG001

**Lower Limit:** 4

**Upper Limit:** 39

**Value:** 21.5

#### Measurement

**Group ID:** BG002

**Lower Limit:** 4

**Upper Limit:** 43

**Value:** 20.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 43.5

**Upper Limit:** 80.7

**Value:** 58.6

#### Measurement

**Group ID:** BG001

**Lower Limit:** 35.8

**Upper Limit:** 84.4

**Value:** 60.1

#### Measurement

**Group ID:** BG002

**Lower Limit:** 35.8

**Upper Limit:** 80.7

**Value:** 59

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 5
**Description:** The Boston Naming Test measures picture naming abilities. The range is 0-60 with higher scores corresponding with better naming abilities.
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Boston Naming Test
**Unit of Measure:** units on a scale
### Measure 6
**Description:** The Western Aphasia Battery Aphasia Quotient range is 0-100 with higher scores demonstrating better language abilities. A score of less than 93.8 is the clinical cutoff for the diagnosis of aphasia.
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Western Aphasia Battery
**Unit of Measure:** units on a scale
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** harnish.18@osu.edu
**Organization:** The Ohio State University
**Phone:** 614-688-1471
**Title:** Stacy Harnish
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 85
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** < 0.001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Weighted Tau U
**Tested Non-Inferiority:** 
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.67
- **Spread:** 
- **Upper Limit:** 1.00
- **Value:** 0.83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.49
- **Spread:** 
- **Upper Limit:** 1.00
- **Value:** 0.75
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.71
- **Spread:** 
- **Upper Limit:** 1.00
- **Value:** 0.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.50
- **Spread:** 
- **Upper Limit:** 1.00
- **Value:** 0.77
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Tau-U effect sizes of \<0.20 were considered small; 0.20 to \<0.60 moderate; 0.60 to \<0.80 large, and \>=0.80 very large. Weighted Tau-U averages in exercise participants and stretching participants were calculated in each block using an online web-based calculator (http://www.singleresearch.org/calculators/tau-u). In the present analysis, any baseline trends over 0.10 were adjusted.
**Dispersion Type:** 80% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** administered before and after each of two, two week aphasia therapy blocks
**Title:** Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means
**Type:** PRIMARY
**Unit of Measure:** Tau U effect size weighted mean
##### Group
**Description:** Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
**ID:** OG000
**Title:** Aphasia Therapy With an Exercise Adjuvant
##### Group
**Description:** Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**ID:** OG001
**Title:** Aphasia Therapy With a Stretching Adjuvant
#### Outcome Measure 2
**Description:** The baseline BDNF levels in participants (ie, the 2 measures prior to the exercise or stretching interventions) showed a great deal of intraparticipant variation. Hence, in an attempt to minimize the intraparticipant variability, we calculated the mean values from samples 1 and 2 to obtain a baseline BDNF measure, samples 3 and 4 to obtain a BDNF measure in the first 6 weeks of aerobic exercise or stretching, and samples 5 and 6 to obtain a measure in the last 6 weeks of the exercise or stretching intervention.
**Parameter Type:** NUMBER
**Population Description:** Complete BDNF datasets from 5 of the 7 participants who completed the study were available. BDNF data from the remaining two participants were not collected due to the PI and study team moving locations and no longer having access to the facilities.
**Reporting Status:** POSTED
**Time Frame:** six samples collected over a 16 week period
**Title:** Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
**ID:** OG000
**Title:** Aphasia Therapy With an Exercise Adjuvant
##### Group
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**ID:** OG001
**Title:** Aphasia Therapy With a Stretching Adjuvant
### Participant Flow Module
#### Group
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.

Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus an aerobic exercise or stretching adjuvant.
**ID:** FG000
**Title:** Aphasia Therapy Alone, Then With Exercise
#### Group
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**ID:** FG001
**Title:** Aphasia Therapy Alone, Then With Stretching
#### Period
**Title:** Period 1: Block 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
#### Period
**Title:** Period 2: Block 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True