## Protocol Section
### Identification Module
**NCT ID:** NCT05025579

**Brief Title:** What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression?

**Official Title:** What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression?

#### Organization Study ID Info
**ID:** 03/15/2019-74
#### Organization
**Class:** OTHER
**Full Name:** Ankara Yildirim Beyazıt University
### Status Module
#### Completion Date
**Date:** 2019-07-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-08-27

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-06-30

**Type:** ACTUAL

#### Start Date
**Date:** 2019-04-01

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2021-08-27
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-24
**Study First Submit QC Date:** 2021-08-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ankara Yildirim Beyazıt University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study was planned to examine the effect of aerobic exercises on depression in geriatric individuals with a diagnosis of depression.

**Detailed Description:** In this study 67 ± 5 years of age averaged and by the physician in geriatric depression diagnosis was placed 38 sedentary geriatric subjects were included. Meet the inclusion criteria geriatric individuals information, vital signs (pulse,"beats /min", blood pressure, " mmHg ", respiration number, respiratory rate,) was recorded. Depression levels, Depression Outcome Scale- KOFDSS to and quality of life is Quality of Life Survey -EUROHIS WHO-QOL) were evaluated. 6-week, 4 days a week aerobic exercise program was applied to geriatric individuals. As aerobic exercise which included the heating and cooling cycle was started the first week and 120 minutes, 160 minutes weekend out and gradually the intensity was given as an exercise program to be increasing. Individuals from the 6-week program were re-evaluated.

### Conditions Module

**Conditions:**

- Aerobic Exercise

- Depression

- Geriatric

- Chronic Illness

**Keywords:**

- Aerobic Exercise

- Depression

- Geriatric

- Chronic Illness

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** The study, 65-75 years of age a in range, geriatric depression diagnosed with and willing to participate in the study is when individuals were included in the study. Geriatrics psychiatric disorders other than depression who, for any reason unable to ride a bike, that static man, to exercise contraindications u found my show compliance with the exercise program and to the individuals who were excluded from the study .

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Considering the protocol suggested in the literature and by examining exercise samples for geriatric individuals, an exercise protocol was created. The first week started with aerobic exercises with a total of 120 minutes, and the next week increased to 160 minutes . A 6-week exercise program was planned and applied 4 days a week in which the intensity was increased gradually. People 's heart rate, blood pressure and respiratory frequency exercise program implementation before and after was recorded in the evaluation form.

**Intervention Names:**

- Other: Aerobic Exercise

**Label:** Exercise group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exercise group

**Description:** Since up in 2 min 10 repetitions active joint movement (while seated knee flexion and extension the ankle plantar and dorsal flexion , standing the hip flexion , extension the , abduction and adduction ) , treadmill for 3 minutes, 0.5 m / sec speed walk with and to adapt both warming bike 5 minutes, RPE ( Rating of Perceived exertion discoverable by exertion rate) will be 2/10 in a way was built.

As aerobic exercise, the first week will be RPE 4/10 for 10 minutes, the second week with RPE 4/10 12 minutes, the third week with RPE 4/10 14 minutes, the fourth week with RPE 4/10, 16 minutes, the fifth week with RPE 5/ 2 0 will be as 18 minutes sixth week RPA 10.6 will form was done 20 minutes of exercise .

Cooling period in the RPE 2.10 will be the 5 minute turning cycling, 5 min active range of motion exercises and stretching was done.

**Name:** Aerobic Exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Change from Clinically useful depression outcome scale score at beginning and 6th. weeks

**Measure:** geriatric depression

**Time Frame:** before and after treatment (24 sessions, beginning and 6th. weeks)

#### Secondary Outcomes

**Description:** Change from World Health Organization Quality of Life Questionnaire (EUROHIS-QOL) score at beginning and 6th. weeks

**Measure:** Life Quality

**Time Frame:** before and after treatment (24 sessions, beginning and 6th. weeks)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 65-75 years of age a in range, geriatric depression diagnosed with and willing to participate in the study is when individuals were included in the study.

Exclusion Criteria:

* Having geriatric psychiatric disorders other than depression, not being able to ride a bike for any reason, have contraindications for exercise, inability to adapt to exercise, not volunteering to participate

**Maximum Age:** 75 Years

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

**Zip:** 06760

**Location 2:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

#### Overall Officials

**Official 1:**

**Affiliation:** Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department ANKARA, Turkey, 06760

**Name:** Rabia Tugba Kilic

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Ankara Yildirim Beyazit University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

**Name:** Bonny Wamukoya Wasıke

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Ankara Health Sciences University Department of Physical Therapy and Rehabilitation

**Name:** Necmiye Un Yildirim

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Blumenthal JA, Babyak MA, Moore KA, Craighead WE, Herman S, Khatri P, Waugh R, Napolitano MA, Forman LM, Appelbaum M, Doraiswamy PM, Krishnan KR. Effects of exercise training on older patients with major depression. Arch Intern Med. 1999 Oct 25;159(19):2349-56. doi: 10.1001/archinte.159.19.2349.

**PMID:** 10547175

**Citation:** Rinaldi P, Mecocci P, Benedetti C, Ercolani S, Bregnocchi M, Menculini G, Catani M, Senin U, Cherubini A. Validation of the five-item geriatric depression scale in elderly subjects in three different settings. J Am Geriatr Soc. 2003 May;51(5):694-8. doi: 10.1034/j.1600-0579.2003.00216.x.

**PMID:** 12752847

**Citation:** Egede LE, Nietert PJ, Zheng D. Depression and all-cause and coronary heart disease mortality among adults with and without diabetes. Diabetes Care. 2005 Jun;28(6):1339-45. doi: 10.2337/diacare.28.6.1339.

**PMID:** 15920049

**Citation:** Lieberwirth C, Wang Z. The social environment and neurogenesis in the adult Mammalian brain. Front Hum Neurosci. 2012 May 8;6:118. doi: 10.3389/fnhum.2012.00118. eCollection 2012.

**PMID:** 22586385

**Citation:** Babyak M, Blumenthal JA, Herman S, Khatri P, Doraiswamy M, Moore K, Craighead WE, Baldewicz TT, Krishnan KR. Exercise treatment for major depression: maintenance of therapeutic benefit at 10 months. Psychosom Med. 2000 Sep-Oct;62(5):633-8. doi: 10.1097/00006842-200009000-00006.

**PMID:** 11020092

**Citation:** Christmas C, Andersen RA. Exercise and older patients: guidelines for the clinician. J Am Geriatr Soc. 2000 Mar;48(3):318-24. doi: 10.1111/j.1532-5415.2000.tb02654.x.

**PMID:** 10733061

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M6147

- Name: Chronic Disease

- Relevance: HIGH

- As Found: Chronic Illness

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002908

- Term: Chronic Disease

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-24
