NCT07575958

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 1, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

April 28, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

sarcopeniaaquatic exercisehydrotherapyaquatic therapysarcopenia ultrasoundGeriatricElderlywater-based exerciseSonographic Thigh Adjustment Ratio(STAR)

Outcome Measures

Primary Outcomes (1)

  • Anterior thigh muscle thickness measured by ultrasound

    Anterior thigh muscle thickness will be measured by musculoskeletal ultrasound. STAR will be calculated by dividing anterior thigh muscle thickness by body mass index.

    From baseline to the end of treatment and 1 month after treatment completion

Secondary Outcomes (10)

  • Sonographic Thigh Adjustment Ratio (STAR)

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

  • Handgrip Strength

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

  • Five Times Chair Stand Test

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

  • Appendicular Skeletal Muscle Mass Index (ASM/height²)

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

  • 4-Meter Gait Speed Test

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

  • +5 more secondary outcomes

Study Arms (2)

Aquatic Exercise Plus Home Exercise Group

EXPERIMENTAL

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.

Behavioral: Aquatic Exercise ProgramBehavioral: Home Exercise Program

Home Exercise Only Group

ACTIVE COMPARATOR

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.

Behavioral: Home Exercise Program

Interventions

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.

Also known as: Hydrotherapy Exercise, Aquatic Therapy, Pool Exercise Program, Water-Based Exercise Training
Aquatic Exercise Plus Home Exercise Group

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.

Aquatic Exercise Plus Home Exercise GroupHome Exercise Only Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaziosmanpasa Research and Education Hospital

Istanbul, Istanbul, 34255, Turkey (Türkiye)

RECRUITING

University of Health Sciences Gaziosmanpaşa Training and Research Hospital

Istanbul, Istanbul, 34255, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30312372BACKGROUND
  • 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: 32941253BACKGROUND

Related Links

MeSH Terms

Conditions

Sarcopenia

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 8, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations