Effects of Aquatic Exercise in Older Adults With Sarcopenia:A Randomized Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Aquatic Exercise Program, Home Exercise Program.
- Кому может быть актуально
- Состояния в реестре: Sarcopenia, Sarcopenia in Elderly. Базовые параметры: от 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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. - Поведенческое 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.
Первичные конечные точки
- Five Times Sit to Stand Test [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
Вторичные конечные точки (10)
- Sonographic Thigh Adjustment Ratio (STAR) [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
- Handgrip Strength [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
- Anterior Thigh Muscle Thickness [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
- Appendicular Skeletal Muscle Mass Index (ASM/height²) [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
- 4-Meter Gait Speed Test [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
- Short Physical Performance Battery (SPPB) [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
- Berg Balance Scale [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
- Timed Up and Go (TUG) Test [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
- Geriatric Depression Scale (GDS) [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-u]
- SF-36 Quality of Life Scale [Срок оценки: Baseline, immediately after the 6-week intervention, and 1 month post-treatment follow-up]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Turkey (Türkiye) · 2 центра
- Gaziosmanpasa Research and Education Hospital — Istanbul
- University of Health Sciences Gaziosmanpaşa Training and Research Hospital — Istanbul
Публикации
- 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( PMID 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. PMID 32941253
Идентификаторы
NCT: NCT07575958 · E-10840098-202.3.02-6633