Older Adults (60 - 85 Years Old)NCT07702227
Functional and Physiological Responses to Multicomponent Exercise in Older Adults
A study testing Multicomponent Exercise Program in people with Older Adults (60 - 85 Years Old) and Aging, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This study will examine functional and physiological responses to a 12-week multicomponent exercise program in community-dwelling older adults. Adults aged 60 to 81 years will be randomly assigned to either a multicomponent exercise group or a control group. Read more about this study
- Who is it for?
- Ages 60 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults (60 - 85 Years Old), Aging, Functional Capacity
- What is being tested?
- Multicomponent Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being 60 years of age or older,
- being able to walk independently,
- not having any serious cardiovascular, neurological, or musculoskeletal disease that would prevent exercise.
- do not use medications that may affect autonomic nervous system function
- Participants with controlled hypertension who were using stable routine medication were eligible, provided that the screening physician considered them medically suitable for exercise participation.
Who cannot join
- diagnosed cardiac arrhythmia,
- uncontrolled hypertension,
- use of medications that may affect autonomic nervous system function,
- inability to perform functional performance tests.
- Uncontrolled hypertension. Regular medication use was reviewed during medical screening. Participants were excluded when a medication or its adverse effects were considered to substantially compromise exercise safety, cardiac rhythm, or the ability to complete the exercise and assessment procedures.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Canakkale Onsekiz Mart University
Çanakkale, 17100
About this study
Official title: Functional and Physiological Responses to a 12-Week Multicomponent Exercise Program in Older Adults: An Exploratory Responder-Non-Responder Analysis
This study will examine functional and physiological responses to a 12-week multicomponent exercise program in community-dwelling older adults. Adults aged 60 to 81 years will be randomly assigned to either a multicomponent exercise group or a control group. The supervised exercise program will be performed twice weekly for 12 weeks and will include aerobic walking, resistance exercises, balance and agility training, flexibility exercises, and cool-down activities. Functional performance will be assessed using the six-minute walk test, the 30-second chair stand test, and the 8-Foot Up and Go test at baseline and after 12 weeks. Resting cardiac autonomic function will be assessed using heart rate variability. In addition, an exploratory responder-non-responder analysis will be conducted to examine whether baseline heart rate variability is associated with individual functional adaptations following the exercise program. This study may help identify physiological markers related to functional responsiveness to exercise in older adults.
- Conditions
- Older Adults (60 - 85 Years Old), Aging, Functional Capacity, Heart Rate Variability (HRV), Exercise Response
- Being tested
- Multicomponent Exercise Program
- Keywords
- heart rate variability, cardiac autonomic function, multicomponent exercise, six-minute walk test, responder non-responder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Exercise ProgramBehavioural
Participants in the exercise group will complete a supervised multicomponent exercise program twice weekly for 12 weeks. Each session will last approximately 45 to 50 minutes and include warm-up, aerobic interval walking, resistance exercises, balance and agility training, flexibility exercises, and cool-down activities. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion scale and exercise difficulty will be progressively increased by increasing repetitions, walking duration, walking pace, and task complexity.
| Study group | Role | What they receive |
|---|---|---|
| multicomponent Exercise group | Experimental | Participants are assigned to either a 12-week supervised multicomponent exercise group or a control group. Outcomes are assessed at baseline and after the 12-week intervention period. Receives: Behavioral: Multicomponent Exercise Program |
| Control Group | No intervention | Participants in the control group will maintain their usual daily activities during the 12-week study period and will not receive the supervised multicomponent exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six-minute walk distance
Functional walking capacity will be assessed using the six-minute walk test. The total distance walked in six minutes will be recorded in meters at baseline and after the 12-week intervention.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Change in 30-second chair stand test performance
Lower-limb functional strength will be assessed using the 30-second chair stand test at baseline and after the 12-week intervention.
Measured: Baseline and after 12 weeks
Change in 8-foot Up-and-Go test performance
Functional mobility and agility will be assessed using the 8-Foot Up-and-Go test at baseline and after the 12-week intervention.
Measured: baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jun 2026
- Primary completion21 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (60 - 85 Years Old)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either a 12-week supervised multicomponent exercise group or a control group. Outcomes are assessed at baseline and after the 12-week intervention period.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Sahin, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702227
- Sponsor's protocol ID
- 2026-YONP-0121
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Physiological Responses to a 12-Week Multicomponent Exercise Program in Older Adults: An Exploratory Responder-Non-Responder Analysis
- ClinicalTrials.gov ID
- NCT07702227
- Acronym / sponsor ID
- 2026-YONP-0121
- Conditions
- Older Adults (60 - 85 Years Old), Aging, Functional Capacity, Heart Rate Variability (HRV), Exercise Response
- Keywords
- heart rate variability, cardiac autonomic function, multicomponent exercise, six-minute walk test, responder non-responder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 14 Jul 2026 (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 will examine functional and physiological responses to a 12-week multicomponent exercise program in community-dwelling older adults. Adults aged 60 to 81 years will be randomly assigned to either a multicomponent exercise group or a control group. The supervised exercise program will be performed twice weekly for 12 weeks and will include aerobic walking, resistance exercises, balance and agility training, flexibility exercises, and cool-down activities. Functional performance will be assessed using the six-minute walk test, the 30-second chair stand test, and the 8-Foot Up and Go test at baseline and after 12 weeks. Resting cardiac autonomic function will be assessed using heart rate variability. In addition, an exploratory responder-non-responder analysis will be conducted to examine whether baseline heart rate variability is associated with individual functional adaptations following the exercise program. This study may help identify physiological markers related to functional responsiveness to exercise in older adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to either a 12-week supervised multicomponent exercise group or a control group. Outcomes are assessed at baseline and after the 12-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| multicomponent Exercise group | Experimental | Behavioral: Multicomponent Exercise ProgramParticipants are assigned to either a 12-week supervised multicomponent exercise group or a control group. Outcomes are assessed at baseline and after the 12-week intervention period. |
| Control Group | No intervention | –Participants in the control group will maintain their usual daily activities during the 12-week study period and will not receive the supervised multicomponent exercise program. |
Who may qualify
- Ages
- 60 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being 60 years of age or older,
- being able to walk independently,
- not having any serious cardiovascular, neurological, or musculoskeletal disease that would prevent exercise.
- do not use medications that may affect autonomic nervous system function
- Participants with controlled hypertension who were using stable routine medication were eligible, provided that the screening physician considered them medically suitable for exercise participation.
Key exclusion criteria (5 listed)
- diagnosed cardiac arrhythmia,
- uncontrolled hypertension,
- use of medications that may affect autonomic nervous system function,
- inability to perform functional performance tests.
- Uncontrolled hypertension. Regular medication use was reviewed during medical screening. Participants were excluded when a medication or its adverse effects were considered to substantially compromise exercise safety, cardiac rhythm, or the ability to complete the exercise and assessment procedures.
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 |
|---|---|---|
| Multicomponent Exercise ProgramParticipants in the exercise group will complete a supervised multicomponent exercise program twice weekly for 12 weeks. Each session will last approximately 45 to 50 minutes and include warm-up, aerobic interval walking, resistance exercises, balance and agility training, flexibility exercises, and cool-down activities. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion scale and exercise difficulty will be progressively increased by increasing repetitions, walking duration, walking pace, and task complexity. | Behavioural | multicomponent Exercise group |
Primary outcome
Change in six-minute walk distance
Time frame: Baseline and 12 weeks
Functional walking capacity will be assessed using the six-minute walk test. The total distance walked in six minutes will be recorded in meters at baseline and after the 12-week intervention.
2 secondary outcomes
Change in 30-second chair stand test performance
Time frame: Baseline and after 12 weeks
Change in 8-foot Up-and-Go test performance
Time frame: baseline and after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Exercise Program in people with Older Adults (60 - 85 Years Old) and Aging, run by Çanakkale Onsekiz Mart University at 1 site 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in six-minute walk distance (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.