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NCT Number: NCT07575958

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia in Elderly Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Research and Education Hospital, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Aquatic Exercise Program

Behavioral

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.

Other names: Hydrotherapy Exercise, Aquatic Therapy, Pool Exercise Program, Water-Based Exercise Training

Home Exercise Program

Behavioral

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.

Primary outcomes

  1. Five Times Sit to Stand Test

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

    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..

Secondary outcomes

  1. Sonographic Thigh Adjustment Ratio (STAR)

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

    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).

  2. Handgrip Strength

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

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

  3. Anterior Thigh Muscle Thickness

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

    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.

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

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

    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).

  5. 4-Meter Gait Speed Test

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

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

  6. Short Physical Performance Battery (SPPB)

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

    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.

  7. Berg Balance Scale

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

    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.

  8. Timed Up and Go (TUG) Test

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

    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.

  9. Geriatric Depression Scale (GDS)

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

    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.

  10. SF-36 Quality of Life Scale

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

SEDA AYDIN, MD

CONTACT

[email protected]

+905530170977

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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