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Clinical Trials/NCT07513025
NCT07513025
Completed
Not Applicable

The Clinical Effectiveness of Progressive Resistance Training With Elastic Band in Postponing and Preventing Sarcopenia Among Older Adults in Rural Long-Term Care Facilities

Cishan Hospital, Ministry of Health and Welfare1 site in 1 country60 target enrollmentStarted: May 5, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Cishan Hospital, Ministry of Health and Welfare
Enrollment
60
Locations
1
Primary Endpoint
Appendicular Skeletal Muscle Mass Index

Overview

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of progressive resistance training using elastic bands in treating and delaying the progression of sarcopenia among older adults in long-term care facilities. Sarcopenia, characterized by a progressive decline in muscle mass and strength, affects more than 20% of individuals aged over 65 in Taiwan and is a significant risk factor for impaired daily functioning, falls, and increased mortality in older adults. While resistance or aerobic exercises are known to improve muscle strength and function in the elderly, such interventions are challenging to implement long-term in rural care facilities due to limited resources.

The study aims to determine:

Whether elastic band progressive resistance training can achieve clinical benefits in treating and delaying sarcopenia with minimal rehabilitation personnel.

Whether this training model can be adapted to rural care facilities and other resource-limited settings, aligning with the goals of Taiwan's Long-Term Care 2.0 program.

Participants will engage in a 12-week program, involving twice-weekly, 30-minute sessions of upper and lower limb resistance training using elastic bands. The training incorporates major muscle groups and proprioceptive neuromuscular facilitation (PNF) techniques.

Primary outcomes:

Skeletal muscle mass index of the limbs Dominant hand grip strength Walking speed SARC-F questionnaire scores

Secondary outcomes:

Maximal voluntary isometric contraction (MVIC) of the dominant hand Muscle thickness assessed via ultrasound Functional activities of the dominant upper limb Calf circumference Quality of life indicators

The study will be conducted in long-term care facilities affiliated with or contracted by the Ministry of Health and Welfare Qishan Hospital. The findings aim to provide evidence for scalable, low-resource sarcopenia interventions suitable for rural and underserved populations.

Detailed Description

Study Objectives Sarcopenia is a progressive condition characterized by the loss of muscle mass and decline in muscle function. The prevalence of sarcopenia in the elderly population aged over 65 years in Taiwan exceeds 20%. Sarcopenia is an independent risk factor for impaired daily functioning, falls, and increased mortality among older adults. Previous studies have demonstrated that resistance or aerobic exercise can improve muscle strength and functionality in the elderly. However, due to manpower constraints, such exercise programs are challenging to implement long-term in rural care facilities. Therefore, a simple and safe resistance training model that minimizes the risk of exercise-related injuries in older populations is needed.

Previous research has shown that progressive resistance training using elastic bands can effectively enhance muscle strength in older adults under safe conditions while reducing the risk of bone and joint injuries associated with traditional resistance training. However, the efficacy of elastic band training in delaying the progression of sarcopenia and determining the optimal exercise prescription for the elderly remain contentious.

This study aims to implement progressive resistance training using elastic bands for the upper and lower limbs of older adults in long-term care facilities to achieve the following expected outcomes:

Demonstrate that progressive resistance training using elastic bands can provide clinical benefits in treating and delaying sarcopenia with minimal rehabilitation personnel, while minimizing the risk of exercise-related injuries.

Apply the findings to rural daycare centers and other facilities with limited manpower resources, aligning with the goals of Taiwan's current Long-Term Care 2.0 program.

Study Methods This study will be conducted in long-term care facilities affiliated with or contracted by the Ministry of Health and Welfare Qishan Hospital, including nursing homes and daycare centers. Older adults with sufficient cognitive function to participate in rehabilitation exercises will undergo a 12-week intervention of progressive resistance training using elastic bands, performed twice per week. The training will target major muscle groups of the upper and lower limbs and incorporate proprioceptive neuromuscular facilitation (PNF) techniques. Each session will last 30 minutes.

The differences in primary and secondary outcomes will be compared before and after the intervention.

Primary outcomes include diagnostic criteria for sarcopenia: appendicular skeletal muscle mass index, dominant hand grip strength, walking speed, and SARC-F questionnaire scores.

Secondary outcomes include maximal voluntary isometric contraction (MVIC) of the dominant hand, muscle thickness assessed via ultrasound, functional activities of the dominant upper limb, calf circumference, and quality of life indicators.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Older adults aged 60 years or above who are either receiving daycare services at long-term care facilities affiliated with or contracted by this hospital, or residents living in the hospital-affiliated nursing home.
  • Individuals with sufficient cognitive and physical capacity to participate in a progressive resistance training program incorporating elastic bands, with each session lasting at least 30 minutes. -

Exclusion Criteria

  • Inability to maintain a seated position for more than one hour.
  • Presence of uncontrolled hypertension, recent infections, major cardiovascular diseases, or other contraindications to exercise training as defined by the American College of Sports Medicine (ACSM).
  • Long-term bedridden individuals unable to participate in the progressive resistance training program incorporating elastic bands.
  • Individuals with respiratory diseases requiring regular oxygen support in daily life.

Arms & Interventions

PRT with EB

Experimental

LTCFs users who receive standard care plus progressive resistance training with elastic band

Intervention: elastic band (Device)

Standard care group

No Intervention

LTCFs users who receive only standard care

Outcomes

Primary Outcomes

Appendicular Skeletal Muscle Mass Index

Time Frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.

ASMMI is defined as appendicular skeletal muscle mass(kg)/height (m\^2). This study utilizes BIA for body muscle mass measurement, considering the accessibility of the equipment and budget constraints.

Handgrip strength of dominant hand

Time Frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.

In this study, grip strength is measured using a JAMAR electronic dynamometer, with a minimum scale of 0.1 pounds. The testing procedure is as follows: The participant is seated with the shoulder in a neutral position, the upper arm relaxed alongside the body, and the elbow flexed at a 90-degree angle. The participant holds the JAMAR dynamometer with their dominant hand. They are instructed to gradually apply force, reaching their maximum grip strength within 3 seconds. Before the test, a practice trial is provided to ensure the participant understands the procedure. The grip strength is tested twice, with a 30-second rest between trials. The average of the two trials is recorded as the final result

Gait speed

Time Frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.

The testing procedure is as follows: A stopwatch is used to measure the time (in seconds) from the command "Ready, go" until the participant crosses a 6-meter distance marked on the floor. Two trials are conducted, with a 10-minute rest between each trial. Walking speed (m/s) is calculated for each trial, and the average of the two trials is used for data analysis.

SARC-F questionnaire

Time Frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.

The SARC-F questionnaire consists of five questions, each scored based on the participant's self-reported responses, with a total score ranging from 0 to 10. Higher scores indicate a higher risk of sarcopenia. The questionnaire is designed for use in various clinical and community settings without requiring specialized equipment or professional expertise, making it suitable for large-scale screening.

Secondary Outcomes

  • maximal voluntary isometric contraction of biceps brachii/ triceps brachii/ quadriceps muscle(From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.)
  • Sonographic thickness of biceps brachii muscle(From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.)
  • Sonographic thickness of quadriceps muscle(From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.)
  • Sonographic thickness of gastrocnemius muscle(From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.)
  • hand dexterity(From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.)
  • Calf Circumference(From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.)
  • EQ-5D questionnaire(From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.)
  • Mini Nutritional Assessment(From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.)

Investigators

Sponsor
Cishan Hospital, Ministry of Health and Welfare
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sheng-Hui Tuan

Doctor

Cishan Hospital, Ministry of Health and Welfare

Study Sites (1)

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