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SarcopeniaNCT07575958

Effects of Aquatic Exercise in Older Adults With Sarcopenia:A Randomized Trial

A study testing Aquatic Exercise Program and Home Exercise Program in people with Sarcopenia and Sarcopenia in Elderly, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Sarcopenia is a geriatric syndrome characterized by age-related loss of skeletal muscle mass, strength, and physical performance, leading to increased risk of falls, functional decline, and reduced quality of life. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Sarcopenia, Sarcopenia in Elderly
What is being tested?
Aquatic Exercise Program and Home Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 May 2026to 29 Oct 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 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥65 years
  • Diagnosis of "definite sarcopenia" according to the ISarcoPRM diagnostic algorithm
  • Not receiving nutritional supplementation and not requiring nutritional support according to the Mini Nutritional Assessment (MNA)
  • Sufficient cognitive ability to understand and follow instructions, including study-related questions and the home exercise program
  • Voluntary participation in the study
  • Ability to ambulate independently (assistive devices such as a cane are allowed; however, fully dependent individuals will be excluded)

Who cannot join

  • Inability to complete assessment tests and questionnaires
  • Presence of severe systemic disease that may contraindicate exercise
  • Severe visual or hearing impairment
  • Presence of a cardiac pacemaker
  • Severe cardiopulmonary disease
  • Uncontrolled hypertension
Show all 10Show fewer
  • Uncontrolled diabetes mellitus
  • Receiving nutritional supplementation
  • Severe anemia
  • Conditions contraindicating hydrotherapy, including aquaphobia (fear of water), behavioral disorders, dyspnea at rest, urinary or fecal incontinence, known chlorine allergy, open wounds, acute systemic illness, epilepsy, tracheostomy, indwelling drainage devices, and immunodeficiency

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Gaziosmanpasa Research and Education Hospital

    Istanbul, Istanbul, 34255

  • University of Health Sciences Gaziosmanpaşa Training and Research Hospital

    Istanbul, Istanbul, 34255

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Aquatic Exercise Program on Muscle Strength, Muscle Mass, Physical Performance and Quality of Life in Older Adults With Sarcopenia: A Randomized Controlled Trial

Sarcopenia is a geriatric syndrome characterized by age-related loss of skeletal muscle mass, strength, and physical performance, leading to increased risk of falls, functional decline, and reduced quality of life. Exercise interventions, particularly resistance training, are effective in managing sarcopenia; however, land-based exercises may be challenging for older adults due to balance impairments, joint problems, and fear of falling.

Pool-based exercise programs may offer a safe and feasible alternative, as water buoyancy reduces joint loading while providing resistance to support muscle strengthening. Despite these potential benefits, evidence regarding the effects of aquatic exercise in individuals with sarcopenia remains limited, especially in Türkiye.

Read more

This study aims to evaluate the effects of a 6-week supervised pool-based exercise program on muscle strength, muscle morphology, physical performance, mood, and quality of life in individuals aged 65 years and older with sarcopenia. Sarcopenia will be identified using the Sonographic Thigh Adjustment Ratio (STAR), based on ultrasound measurements of anterior thigh muscle thickness. In addition, appendicular skeletal muscle mass will be assessed using bioelectrical impedance analysis (ASM/height²).

Outcome measures will include ultrasound-based muscle thickness, STAR, muscle strength, functional performance tests, depressive symptoms, and health-related quality of life. Assessments will be performed at baseline, immediately after the intervention, and at 1-month follow-up.

Read the detailed description

Participants aged 65 years and older who present to the Physical Medicine and Rehabilitation outpatient clinic and volunteer to participate in the study will be screened for sarcopenia. Individuals diagnosed with definite sarcopenia according to the ISarcoPRM diagnostic algorithm will be included in the study.

The aim of the study is to evaluate the effects of a 6-week supervised pool-based exercise program on muscle strength, muscle mass, muscle morphology, physical performance, mood, and health-related quality of life.

Muscle strength will be assessed using a handgrip dynamometer and the Five Times Chair Stand Test. Muscle mass will be evaluated using bioelectrical impedance analysis (BIA), and appendicular skeletal muscle mass will be calculated. Gait speed will be assessed using the 4-meter walking test. Balance and mobility will be evaluated using the Berg Balance Scale and the Timed Up and Go (TUG) test. Physical performance will be assessed using the Short Physical Performance Battery (SPPB). Psychological status will be evaluated using the Geriatric Depression Scale, and health-related quality of life will be assessed using the SF-36 questionnaire.

In addition, anterior thigh muscle thickness will be measured using musculoskeletal ultrasound. The Sonographic Thigh Adjustment Ratio (STAR) will be calculated by dividing anterior thigh muscle thickness by body mass index, providing an ultrasound-based assessment of muscle quantity and quality.

All participants will undergo a supervised pool-based exercise program for 6 weeks. The exercise program will be designed to improve muscle strength, balance, and functional performance.

All outcome measures will be evaluated at three time points: before the intervention (baseline), immediately after completion of the 6-week exercise program, and at 1 month following the end of the intervention.

Being tested
Aquatic Exercise Program, Home Exercise Program
Keywords
sarcopenia, aquatic exercise, hydrotherapy, aquatic therapy, sarcopenia ultrasound, Geriatric, Elderly, water-based exercise, Sonographic Thigh Adjustment Ratio(STAR)
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aquatic Exercise ProgramBehavioural

    Also called Hydrotherapy Exercise, Aquatic Therapy, Pool Exercise Program, Water-Based Exercise Training

    The aquatic exercise program will be conducted under supervision in a pool environment for a total of 15 sessions over 6 weeks. The program will consist of 2 sessions per week during the first 3 weeks and 3 sessions per week during the last 3 weeks. Each session will include structured exercises designed to improve muscle strength, balance, and functional performance in older adults with sarcopenia. Participants will also continue a standardized home exercise program throughout the study period.

  • Home Exercise ProgramBehavioural

    Participants in the control group will perform a standardized home exercise program for a total of 6 weeks. The program will consist of exercises designed to improve muscle strength, balance, and functional performance in older adults with sarcopenia. Participants will be instructed to perform the exercises regularly at home throughout the study period. No supervised aquatic exercise or additional intervention will be provided.

Study groups in NCT07575958
Study groupRoleWhat they receive
Aquatic Exercise Plus Home Exercise GroupExperimentalParticipants in this group will receive an aquatic exercise program in addition to a standardized home exercise program. The aquatic exercise program will be conducted under supervision and will include exercises aimed at improving muscle strength, balance, and physical performance. The home exercise program will be prescribed to be performed regularly throughout the study period.
Receives: Behavioral: Aquatic Exercise Program; Behavioral: Home Exercise Program
Home Exercise Only GroupActive comparatorParticipants in this group will receive only a standardized home exercise program. The program will include exercises targeting muscle strength and physical function and will be performed regularly throughout the study period.
Receives: Behavioral: Home Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Five Times Sit to Stand Test

    Lower extremity muscle strength and functional performance will be evaluated using the Five Times Chair Stand Test. The time required to complete five sit-to-stand repetitions will be recorded in seconds..

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

Secondary outcomes (10)
  1. Sonographic Thigh Adjustment Ratio (STAR)

    Anterior thigh muscle thickness will be measured using musculoskeletal ultrasound, and the Sonographic Thigh Adjustment Ratio (STAR) will be calculated by dividing muscle thickness by body mass index (BMI, kg/m²).

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

  2. Handgrip Strength

    Muscle strength will be assessed using a handgrip dynamometer (Jamar). Grip strength will be recorded in kilograms.

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

  3. Anterior Thigh Muscle Thickness

    Anterior thigh muscle thickness will be measured using musculoskeletal ultrasound. STAR (Sonographic Thigh Adjustment Ratio) will be calculated by dividing anterior thigh muscle thickness by body mass index.

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

  4. Appendicular Skeletal Muscle Mass Index (ASM/height²)

    Appendicular skeletal muscle mass will be measured using bioelectrical impedance analysis (BIA). ASM will be calculated as the sum of lean mass of all four extremities and normalized to height squared (kg/m²).

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

  5. 4-Meter Gait Speed Test

    Gait speed will be assessed using the 4-meter walking test, and walking speed will be recorded in meters per second.

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

  6. Short Physical Performance Battery (SPPB)

    Physical performance will be evaluated using the Short Physical Performance Battery (SPPB), which includes balance, gait speed, and chair stand tests. Scores range from 0 to 12, with higher scores indicating better performance.

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

  7. Berg Balance Scale

    Balance will be assessed using the Berg Balance Scale, consisting of 14 items evaluating static and dynamic balance. Total scores range from 0 to 56, with higher scores indicating better balance performance.

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

  8. Timed Up and Go (TUG) Test

    Mobility and functional performance will be evaluated using the Timed Up and Go test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds.

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

  9. Geriatric Depression Scale (GDS)

    Depressive symptoms will be assessed using the 30-item Geriatric Depression Scale (GDS-30), a self-report questionnaire designed to evaluate depressive symptoms in older adults. Total scores range from 0 to 30, with higher scores indicating greater depressive symptom severity.

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-u

  10. SF-36 Quality of Life Scale

    Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates multiple domains including physical functioning, bodily pain, vitality, social functioning, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life.

    Measured: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start1 May 2026
  3. Primary completion24 Aug 2026
  4. Study completion29 Oct 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to two groups. Both groups will receive a home-based exercise program, while the intervention group will additionally participate in a 6-week structured water-based exercise program. Outcomes including muscle strength, physical performance, and quality of life will be measured before and after the intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07575958
Sponsor's protocol ID
E-10840098-202.3.02-6633
Status last verified
Sep 2026
First submitted
28 Apr 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The dataset contains sensitive personal and health-related information, and participants did not provide consent for public data sharing. Data may be made available in aggregated form upon reasonable request.

Publications

  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

    PubMed 30312372
  • Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

    PubMed 32941253

Questions about this trial

What is this clinical trial studying?

A study testing Aquatic Exercise Program and Home Exercise Program in people with Sarcopenia and Sarcopenia in Elderly, run by Gaziosmanpasa Research and Education Hospital 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 6 inclusion and 10 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 25 Sep 2026. 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?

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?

Five Times Sit to Stand Test (time frame: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up). 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 NCT07575958, which also lists 2 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 25 Sep 2026.

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