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

7 maja 2026 zaktualizowane przez: Seda Aydın, Gaziosmanpasa Research and Education Hospital

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.

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

44

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Turcja (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turcja (Türkiye), 34255
        • Rekrutacyjny
        • Gaziosmanpasa Research and Education Hospital
        • Kontakt:
      • Istanbul, Istanbul, Turcja (Türkiye), 34255
        • Rekrutacyjny
        • University of Health Sciences Gaziosmanpaşa Training and Research Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

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

Exclusion Criteria:

  1. Inability to complete assessment tests and questionnaires
  2. Presence of severe systemic disease that may contraindicate exercise
  3. Severe visual or hearing impairment
  4. Presence of a cardiac pacemaker
  5. Severe cardiopulmonary disease
  6. Uncontrolled hypertension
  7. Uncontrolled diabetes mellitus
  8. Receiving nutritional supplementation
  9. Severe anemia
  10. 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Aquatic Exercise Plus Home Exercise Group
Participants 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.
Behawioralne: Aquatic Exercise Program
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.
Inne nazwy:
  • Terapia wodna
  • Hydrotherapy Exercise
  • Pool Exercise Program
  • Water-Based Exercise Training
Behawioralne: Home Exercise Program
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.
Aktywny komparator: Home Exercise Only Group
Participants 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.
Behawioralne: Home Exercise Program
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Anterior thigh muscle thickness measured by ultrasound
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sonographic Thigh Adjustment Ratio (STAR)
Ramy czasowe: 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).
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up
Handgrip Strength
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up
Five Times Chair Stand Test
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up
Appendicular Skeletal Muscle Mass Index (ASM/height²)
Ramy czasowe: 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).
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up
4-Meter Gait Speed Test
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up
Short Physical Performance Battery (SPPB)
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up
Timed Up and Go (TUG) Test
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up
Berg Balance Scale
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up
Geriatric Depression Scale (GDS)
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-u
SF-36 Quality of Life Scale
Ramy czasowe: 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.
Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Gaziosmanpasa Research and Education Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2026

Ukończenie studiów (Szacowany)

1 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

28 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 maja 2026

Pierwszy wysłany (Rzeczywisty)

8 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • E-10840098-202.3.02-6633

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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