Effects of Aquatic Exercise in Older Adults With Sarcopenia:A Randomized Trial
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: SEDA AYDIN, MD
- Número de telefone: +905530170977
- E-mail: Sedaaydin40@hotmail.com
Locais de estudo
-
-
Istanbul
-
Istanbul, Istanbul, Turquia (Türkiye), 34255
- Recrutamento
- Gaziosmanpasa Research and Education Hospital
-
Contato:
- SEDA AYDIN, MD
- Número de telefone: +905530170977
- E-mail: Sedaaydin40@hotmail.com
-
Istanbul, Istanbul, Turquia (Türkiye), 34255
- Recrutamento
- University of Health Sciences Gaziosmanpaşa Training and Research Hospital
-
Contato:
- SEDA AYDIN, MD
- Número de telefone: +905530170977
- E-mail: Sedaaydin40@hotmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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.
Outros nomes:
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.
|
|
Comparador Ativo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Five Times Sit to Stand Test
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sonographic Thigh Adjustment Ratio (STAR)
Prazo: 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
Prazo: 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
|
|
Appendicular Skeletal Muscle Mass Index (ASM/height²)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
|
|
Anterior Thigh Muscle Thickness
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- E-10840098-202.3.02-6633
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .