Sleep QualityNCT07181460
The Effect of Exercise on Sleep Quality in Elderly Individuals
A study testing Exercises Program in people with Sleep Quality, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of this study was to examine the effects of regular exercise on sleep quality in older adults. The study will assess changes in sleep quality resulting from a structured exercise program using objective and subjective measurement tools. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Exercises Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 15 Apr 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being 65 years of age or older,
- Being a resident of the Kadıköy Municipality Social Life House,
- Being able to independently carry out daily living activities,
- Not having any serious cardiopulmonary, neurological, or orthopedic health problems that would prevent exercise,
- Being willing to participate in the study and providing written consent,
- Being at a level where cognitive status does not prevent participation in exercise.
Who cannot join
- Those with serious cardiopulmonary, neurological, or orthopedic diseases,
- Individuals who exercise regularly,
- Individuals who did not complete the study process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The primary objective of this study was to examine the effects of regular exercise on sleep quality in older adults. The study will assess changes in sleep quality resulting from a structured exercise program using objective and subjective measurement tools.
Read the detailed description
The sample size of this study consists of a total of 18 (female and male) individuals selected in accordance with the specified inclusion and exclusion criteria.
The Sociodemographic Patient Information Form, Pittsburgh Sleep Quality Index (PSQI), SF-12/Short Form-12 Health Survey, Modified Medical Research Council Dyspnea Scale, Timed Up and Go Test, and 6-Minute Walk Test will be evaluated at the Kadıköy Municipality Living Center. All evaluations will be collected at the beginning of the study and at the end of the 16th week. Our online exercises will continue for 16 weeks.
- Conditions
- Sleep Quality
- Being tested
- Exercises Program
- Keywords
- Sleep Quality, Elderly, Exercises, Telerehabilitation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises ProgramOther
A program of low-intensity, safe, and functional movements was designed for older adults. It included a warm-up, breathing exercises, chair exercises, strength and mobility exercises, balance exercises, stretching, and a cool-down.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Study Group | Experimental | The sample size was determined as 18 elderly individuals. Receives: Other: Exercises Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item self-report measure widely used in clinical and research settings that measures sleep quality and sleep-related disturbances based on self-report over a one-month period.
Measured: 16 weeks
SF-12 / Short Form-12 Health Survey
The SF-12 is a brief, validated health status scale derived from the SF-36 and enhanced to reproduce physical and mental component summary scores with 12 questions to reduce response burden for group comparisons.
Measured: 16 weeks
Modified Medical Research Council (mMRC) Dyspnea Scale
The mMRC is a brief, five-point self-assessment scale from 0 to 4 that rates the impact of breathlessness on daily activities and is commonly used to classify symptom severity in respiratory diseases such as COPD.
Measured: 16 weeks
Timed Up and Go (TUG) Test
The TUG test is described as a rapid way to quantify baseline functional mobility and fall risk in which the time it takes for the patient to get up from a chair, walk 3 meters, turn, and sit down again is measured chronometrically.
Measured: 16 weeks
6-Minute Walk Test (6MWT)
The 6MWT is a submaximal exercise capacity test that measures the total distance a patient walks in 6 minutes; detailed guidelines for its application, safety, evaluation, and interpretation have been published by the American Thoracic Society.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Develi, Yeditepe University
- Investigators
- Feryal Subaşı, Principal investigator, Yeditepe UniversityDilara Karaoğlu, Study director, Yeditepe UniversityDeniz Aslan, MSc, Study chair, Yeditepe UniversityIrmak Sıla Çetinel, Study chair, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181460
- Sponsor's protocol ID
- IrmakS
- Status last verified
- Nov 2025
- First submitted
- 11 Sep 2025
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Sleep Quality in Elderly Individuals
- ClinicalTrials.gov ID
- NCT07181460
- Acronym / sponsor ID
- IrmakS
- Conditions
- Sleep Quality
- Keywords
- Sleep Quality, Elderly, Exercises, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 18 Sep 2025 (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.
The primary objective of this study was to examine the effects of regular exercise on sleep quality in older adults. The study will assess changes in sleep quality resulting from a structured exercise program using objective and subjective measurement tools.
Detailed description
The sample size of this study consists of a total of 18 (female and male) individuals selected in accordance with the specified inclusion and exclusion criteria.
The Sociodemographic Patient Information Form, Pittsburgh Sleep Quality Index (PSQI), SF-12/Short Form-12 Health Survey, Modified Medical Research Council Dyspnea Scale, Timed Up and Go Test, and 6-Minute Walk Test will be evaluated at the Kadıköy Municipality Living Center. All evaluations will be collected at the beginning of the study and at the end of the 16th week. Our online exercises will continue for 16 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Study Group | Experimental | Other: Exercises ProgramThe sample size was determined as 18 elderly individuals. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Being 65 years of age or older,
- Being a resident of the Kadıköy Municipality Social Life House,
- Being able to independently carry out daily living activities,
- Not having any serious cardiopulmonary, neurological, or orthopedic health problems that would prevent exercise,
- Being willing to participate in the study and providing written consent,
Key exclusion criteria (3 listed)
- Those with serious cardiopulmonary, neurological, or orthopedic diseases,
- Individuals who exercise regularly,
- Individuals who did not complete the study process.
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 |
|---|---|---|
| Exercises ProgramA program of low-intensity, safe, and functional movements was designed for older adults. It included a warm-up, breathing exercises, chair exercises, strength and mobility exercises, balance exercises, stretching, and a cool-down. | Other | Experimental: Study Group |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 16 weeks
The PSQI is a 19-item self-report measure widely used in clinical and research settings that measures sleep quality and sleep-related disturbances based on self-report over a one-month period.
SF-12 / Short Form-12 Health Survey
Time frame: 16 weeks
The SF-12 is a brief, validated health status scale derived from the SF-36 and enhanced to reproduce physical and mental component summary scores with 12 questions to reduce response burden for group comparisons.
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: 16 weeks
The mMRC is a brief, five-point self-assessment scale from 0 to 4 that rates the impact of breathlessness on daily activities and is commonly used to classify symptom severity in respiratory diseases such as COPD.
Timed Up and Go (TUG) Test
Time frame: 16 weeks
The TUG test is described as a rapid way to quantify baseline functional mobility and fall risk in which the time it takes for the patient to get up from a chair, walk 3 meters, turn, and sit down again is measured chronometrically.
6-Minute Walk Test (6MWT)
Time frame: 16 weeks
The 6MWT is a submaximal exercise capacity test that measures the total distance a patient walks in 6 minutes; detailed guidelines for its application, safety, evaluation, and interpretation have been published by the American Thoracic Society.
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 25 Nov 2025.
- 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.
Feryal Subaşı principal investigator
Yeditepe University
Dilara Karaoğlu study director
Yeditepe University
Deniz Aslan, MSc study chair
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises Program in people with Sleep Quality, run by Yeditepe 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 6 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: opening soon, as of the sponsor's last update on 25 Nov 2025. 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?
Contact Elif Develi, PhD C (0905555936293, elifstn@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: 16 weeks). The study lists 5 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 25 Nov 2025.