Aerobic ExerciseNCT05025579
What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression?
A study testing Aerobic Exercise in people with Aerobic Exercise and Depression, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of aerobic exercises on depression in geriatric individuals with a diagnosis of depression. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Aerobic Exercise, Depression, Geriatric
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Ankara, 06760
Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Ankara
About this study
This study was planned to examine the effect of aerobic exercises on depression in geriatric individuals with a diagnosis of depression.
Read the 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
- Aerobic Exercise, Depression, Geriatric, Chronic Illness
- Being tested
- Aerobic Exercise
- Keywords
- Aerobic Exercise, Depression, Geriatric, Chronic Illness
- Medical subject headings
- Depression, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
geriatric depression
Change from Clinically useful depression outcome scale score at beginning and 6th. weeks
Measured: before and after treatment (24 sessions, beginning and 6th. weeks)
Secondary outcomes (1)
Life Quality
Change from World Health Organization Quality of Life Questionnaire (EUROHIS-QOL) score at beginning and 6th. weeks
Measured: before and after treatment (24 sessions, beginning and 6th. weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Apr 2019
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabia Tugba Kilic, Principal investigator, Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department ANKARA, Turkey, 06760Bonny Wamukoya Wasıke, Study director, Ankara Yildirim Beyazit University, Faculty of Health Sciences, Physiotherapy and Rehabilitation DepartmentNecmiye Un Yildirim, Study chair, Ankara Health Sciences University Department of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025579
- Sponsor's protocol ID
- 03/15/2019-74
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10547175Rinaldi 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.
PubMed 12752847Egede 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.
PubMed 15920049Lieberwirth 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.
PubMed 22586385Babyak 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.
PubMed 11020092Christmas 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.
PubMed 10733061
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression?
- ClinicalTrials.gov ID
- NCT05025579
- Acronym / sponsor ID
- 03/15/2019-74
- Conditions
- Aerobic Exercise, Depression, Geriatric, Chronic Illness
- Keywords
- Aerobic Exercise, Depression, Geriatric, Chronic Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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 .
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Aerobic ExerciseConsidering 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. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseSince 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. | Other | Exercise group |
Primary outcome
geriatric depression
Time frame: before and after treatment (24 sessions, beginning and 6th. weeks)
Change from Clinically useful depression outcome scale score at beginning and 6th. weeks
1 secondary outcome
Life Quality
Time frame: before and after treatment (24 sessions, beginning and 6th. weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Background: PubMed 10547175Blumenthal 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.
- Background: PubMed 12752847Rinaldi 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.
- Background: PubMed 15920049Egede 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.
- Background: PubMed 22586385Lieberwirth 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.
- Background: PubMed 11020092Babyak 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.
- Background: PubMed 10733061Christmas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia Tugba Kilic principal investigator
Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department ANKARA, Turkey, 06760
Bonny Wamukoya Wasıke study director
Ankara Yildirim Beyazit University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Necmiye Un Yildirim study chair
Ankara Health Sciences University Department of Physical Therapy and Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Aerobic Exercise and Depression, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
geriatric depression (time frame: before and after treatment (24 sessions, beginning and 6th. weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05025579, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.