Older AdultsNCT07522125
Effects of a Multicomponent Exercise Program on Frailty, Cognitive Function, and Sleep Quality in Older Adults
A study testing The Multicomponent Exercise Program in people with Older Adults, run by Neslihan Lok at 1 site in Turkey (Türkiye).
Trial summary
This study was aimed to examine the effects of participation in a 12-week multicomponent exercise program on frailty, cognitive function, and sleep quality among older adults. The primary research questions of this study are as follows: 1. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults
- What is being tested?
- The Multicomponent Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2025to 10 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 65 years or older, absence of severe physical disability,
- no medical contraindications to exercise,
- a Mini-Mental State Examination (MMSE) score ≥24 indicating no significant cognitive impairment,
- provision of written informed consent.
Who cannot join
- the presence of severe cardiovascular disease,
- diagnosed cognitive impairment (MMSE <24),
- any condition that could prevent participation in physical exercise.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Metropolitan Municipality Healthy Life Center
Ankara, 06000
About this study
Official title: Effects of a Multicomponent Exercise Program on Frailty, Cognitive Function, and Sleep Quality in Older Adults: A Randomized Controlled Trial
This study was aimed to examine the effects of participation in a 12-week multicomponent exercise program on frailty, cognitive function, and sleep quality among older adults.
The primary research questions of this study are as follows:
Read more
- Is a multicomponent exercise program effective in reducing frailty levels in older adults?
- Is a multicomponent exercise program effective in improving cognitive functions (memory, attention, and executive functions) in older adults?
- Is a multicomponent exercise program effective in improving sleep quality in older adults? The study hypothesizes that participation in a multicomponent exercise program will lead to a reduction in frailty levels, improvement in cognitive functions, and enhancement of sleep quality among older adults.
Researchers were compared the multicomponent exercise program to a control group (no intervention) to see if the multicomponent exercise program works on frailty, cognitive function, and sleep quality among older adults.
Intervention group participants were:
- attended the multicomponent exercise program, 12-week period, with sessions held twice weekly, each lasting 45-60 minutes, in groups of 6-8 participants at a municipally affiliated healthy living center under nurse supervision.
Read the detailed description
The study was conducted with elderly individuals aged 65 and over enrolled in a municipal wellness centre meeting the inclusion-exclusion criteria. A total of 110 elderly individuals were included in the study. These individuals were randomly assigned to two groups: intervention and control groups. Pre-test data were collected November 2025 in a quiet room at the wellness centre by outcome assessors from both the intervention and control groups using the "Personal Information Form", "Edmonton Frail Scale (EFS)", "Mini Mental State Examination (MMSE)" and "Pittsburgh Sleep Quality Index (PSQI)" on a self-report basis. The Multicomponent Exercise Program was administered to the intervention group for 12 weeks, twice a week, in groups of 6-8 people, in sessions lasting 45-60 minutes each, under nurse supervision. At the end of the Multicomponent Exercise Program, both the intervention and control groups were administered the "Edmonton Frail Scale (EFS)", "Mini Mental State Examination (MMSE)" and "Pittsburgh Sleep Quality Index (PSQI)" as a post-test between January and February 2026. The control group received no intervention during the 12-week program; individuals continued with their daily living activities.
- Conditions
- Older Adults
- Being tested
- The Multicomponent Exercise Program
- Keywords
- older adults, frailty, Cognitive Function, Sleep Quality, Multicomponent Exercise Program, nursing
- Medical subject headings
- Frailty, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Multicomponent Exercise ProgramBehavioural
The program is conducted twice a week for 12 weeks, in sessions lasting 45-60 minutes each, at a municipal health center, in groups of 6-8 people, and under the supervision of a nurse. Each exercise session consists of four phases: warm-up, aerobic exercise, strength and balance training, and cool-down. The warm-up phase includes light-paced walking and range of motion exercises; the aerobic phase involves moderate-intensity walking and rhythmic movements; the strength and balance exercise phase uses resistance bands and light weights to target upper and lower extremity muscle groups; and exercises aimed at improving postural stability through functional activities such as sit-to-stand, single-leg standing, and tandem walking. The cool-down phase includes static stretching exercises, breathing exercises, and relaxation techniques.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group was a group of 55 people consisting of older adults who followed the 12-week Multicomponent Exercise Program. Receives: Behavioral: The Multicomponent Exercise Program |
| Control Group | No intervention | The control group consisted of 55 older adults who attended receive any exercise intervention and were instructed to continue their routine daily activities for 12 weeks without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty total mean score
Frailty was assessed using the Edmonton Frail Scale (EFS), a multidimensional instrument comprising nine domains that evaluate frailty in older adults. Total scores range from 0 to 17, with higher scores indicating increased frailty.
Measured: From enrollment to the end of the multicomponent exercise program at 12 weeks
Cognitive function total mean score
Cognitive function was measured using the Mini-Mental State Examination (MMSE), which evaluates orientation, registration, attention and calculation, recall, and language skills. Scores range from 0 to 30, with higher scores reflecting better cognitive performance
Measured: From enrollment to the end of the multicomponent exercise program at 12 weeks
Sleep quality total mean score
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), which consists of seven components evaluating sleep quality over the past month. Higher total scores indicate poorer sleep quality
Measured: From enrollment to the end of the multicomponent exercise program at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start3 Nov 2025
- Primary completion26 Jan 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies 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
- This study was a randomized controlled trial with pre-test and post-test control groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neslihan Lok
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Sponsor-investigator, Neslihan Lok, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522125
- Sponsor's protocol ID
- SelcukU-GUzun-003
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Exercise Program on Frailty, Cognitive Function, and Sleep Quality in Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07522125
- Acronym / sponsor ID
- SelcukU-GUzun-003
- Conditions
- Older Adults
- Keywords
- older adults, frailty, Cognitive Function, Sleep Quality, Multicomponent Exercise Program, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Neslihan LokUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 13 Apr 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 was aimed to examine the effects of participation in a 12-week multicomponent exercise program on frailty, cognitive function, and sleep quality among older adults.
The primary research questions of this study are as follows:
- Is a multicomponent exercise program effective in reducing frailty levels in older adults?
- Is a multicomponent exercise program effective in improving cognitive functions (memory, attention, and executive functions) in older adults?
- Is a multicomponent exercise program effective in improving sleep quality in older adults? The study hypothesizes that participation in a multicomponent exercise program will lead to a reduction in frailty levels, improvement in cognitive functions, and enhancement of sleep quality among older adults.
Researchers were compared the multicomponent exercise program to a control group (no intervention) to see if the multicomponent exercise program works on frailty, cognitive function, and sleep quality among older adults.
Intervention group participants were:
- attended the multicomponent exercise program, 12-week period, with sessions held twice weekly, each lasting 45-60 minutes, in groups of 6-8 participants at a municipally affiliated healthy living center under nurse supervision.
Detailed description
The study was conducted with elderly individuals aged 65 and over enrolled in a municipal wellness centre meeting the inclusion-exclusion criteria. A total of 110 elderly individuals were included in the study. These individuals were randomly assigned to two groups: intervention and control groups. Pre-test data were collected November 2025 in a quiet room at the wellness centre by outcome assessors from both the intervention and control groups using the "Personal Information Form", "Edmonton Frail Scale (EFS)", "Mini Mental State Examination (MMSE)" and "Pittsburgh Sleep Quality Index (PSQI)" on a self-report basis. The Multicomponent Exercise Program was administered to the intervention group for 12 weeks, twice a week, in groups of 6-8 people, in sessions lasting 45-60 minutes each, under nurse supervision. At the end of the Multicomponent Exercise Program, both the intervention and control groups were administered the "Edmonton Frail Scale (EFS)", "Mini Mental State Examination (MMSE)" and "Pittsburgh Sleep Quality Index (PSQI)" as a post-test between January and February 2026. The control group received no intervention during the 12-week program; individuals continued with their daily living activities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was a randomized controlled trial with pre-test and post-test control groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The Multicomponent Exercise ProgramThe intervention group was a group of 55 people consisting of older adults who followed the 12-week Multicomponent Exercise Program. |
| Control Group | No intervention | –The control group consisted of 55 older adults who attended receive any exercise intervention and were instructed to continue their routine daily activities for 12 weeks without any intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age 65 years or older, absence of severe physical disability,
- no medical contraindications to exercise,
- a Mini-Mental State Examination (MMSE) score ≥24 indicating no significant cognitive impairment,
- provision of written informed consent.
Key exclusion criteria (3 listed)
- the presence of severe cardiovascular disease,
- diagnosed cognitive impairment (MMSE <24),
- any condition that could prevent participation in physical exercise.
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 |
|---|---|---|
| The Multicomponent Exercise ProgramThe program is conducted twice a week for 12 weeks, in sessions lasting 45-60 minutes each, at a municipal health center, in groups of 6-8 people, and under the supervision of a nurse. Each exercise session consists of four phases: warm-up, aerobic exercise, strength and balance training, and cool-down. The warm-up phase includes light-paced walking and range of motion exercises; the aerobic phase involves moderate-intensity walking and rhythmic movements; the strength and balance exercise phase uses resistance bands and light weights to target upper and lower extremity muscle groups; and exercises aimed at improving postural stability through functional activities such as sit-to-stand, single-leg standing, and tandem walking. The cool-down phase includes static stretching exercises, breathing exercises, and relaxation techniques. | Behavioural | Intervention |
Primary outcome
Frailty total mean score
Time frame: From enrollment to the end of the multicomponent exercise program at 12 weeks
Frailty was assessed using the Edmonton Frail Scale (EFS), a multidimensional instrument comprising nine domains that evaluate frailty in older adults. Total scores range from 0 to 17, with higher scores indicating increased frailty.
Cognitive function total mean score
Time frame: From enrollment to the end of the multicomponent exercise program at 12 weeks
Cognitive function was measured using the Mini-Mental State Examination (MMSE), which evaluates orientation, registration, attention and calculation, recall, and language skills. Scores range from 0 to 30, with higher scores reflecting better cognitive performance
Sleep quality total mean score
Time frame: From enrollment to the end of the multicomponent exercise program at 12 weeks.
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), which consists of seven components evaluating sleep quality over the past month. Higher total scores indicate poorer sleep quality
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 13 Apr 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 The Multicomponent Exercise Program in people with Older Adults, run by Neslihan Lok 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 4 inclusion and 3 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 13 Apr 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?
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?
Frailty total mean score (time frame: From enrollment to the end of the multicomponent exercise program at 12 weeks). The study lists 3 primary outcomes in all. 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 13 Apr 2026.