Effectiveness of RPT With Elastic Band in Tx of Sarcopenia in LTCFs

NCT07513025 | Recruiting

• 1 other identifier: CHIS11403
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Long Term Care Facility

Keywords

sarcopenia; elastic band; progressive resistance training; long-term care facility

Outcome Measures

Primary Outcomes (4)

• Appendicular Skeletal Muscle Mass Index

  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.

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

• Handgrip strength of dominant hand

  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

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

• Gait speed

  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.

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

• SARC-F questionnaire

  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.

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

Secondary Outcomes (8)

• 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.

Study Arms (2)

PRT with EB

EXPERIMENTAL

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

Device: elastic band

Standard care group

NO INTERVENTION

LTCFs users who receive only standard care

Interventions

elastic band DEVICE

Participants in the experimental group will receive standard care plus progressive resistance training with elastic band (PRT-EB). The PRT-EB is planned to last for 12 weeks, with at least two sessions per week and a minimum interval of one day between sessions. Before each training session, participants will perform a 5-15-minute warm-up exercise led by the research staff. This will be followed by a 30-minute main rehabilitation exercise program and a subsequent 5-15-minute cool-down session. The elastic bands used in this study are Thera-Bands. The resistance increases by 25% with each successive color, except for silver and gold, which increase by 40%. This study will utilize six different colors of Thera-Bands-yellow, red, green, blue, black, and silver-following the principle of progression, with resistance levels increasing every two weeks. The resistance training program targets major muscle groups of both the upper and lower body, focusing on three muscle groups per section.

PRT with EB

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cishan Hospital, Ministry of Health and Welfare: lead

Study Sites (1)

CiShan hospital, MOHW

Kaohsiung City, 842, Taiwan

RECRUITING

Related Publications (12)

• Inder JD, Carlson DJ, Dieberg G, McFarlane JR, Hess NC, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis to optimize benefit. Hypertens Res. 2016 Feb;39(2):88-94. doi: 10.1038/hr.2015.111. Epub 2015 Oct 15.

  PMID: 26467494 BACKGROUND

• Baek SH, Sung JH, Park JW, Son MH, Lee JH, Kim BJ. Usefulness of muscle ultrasound in appendicular skeletal muscle mass estimation for sarcopenia assessment. PLoS One. 2023 Jan 17;18(1):e0280202. doi: 10.1371/journal.pone.0280202. eCollection 2023.

  PMID: 36649288 RESULT

• Chen KM, Li CH, Huang HT, Cheng YY. Feasible modalities and long-term effects of elastic band exercises in nursing home older adults in wheelchairs: A cluster randomized controlled trial. Int J Nurs Stud. 2016 Mar;55:4-14. doi: 10.1016/j.ijnurstu.2015.11.004. Epub 2015 Nov 28.

  PMID: 26655368 RESULT

• Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.

  PMID: 31343601 RESULT

• Akehurst E, Scott D, Rodriguez JP, Gonzalez CA, Murphy J, McCarthy H, Dorgo S, Hayes A. Associations of sarcopenia components with physical activity and nutrition in Australian older adults performing exercise training. BMC Geriatr. 2021 Apr 26;21(1):276. doi: 10.1186/s12877-021-02212-y.

  PMID: 33902464 RESULT

• Vlietstra L, Hendrickx W, Waters DL. Exercise interventions in healthy older adults with sarcopenia: A systematic review and meta-analysis. Australas J Ageing. 2018 Sep;37(3):169-183. doi: 10.1111/ajag.12521. Epub 2018 Apr 11.

  PMID: 29638028 RESULT

• Chen GB, Lin CW, Huang HY, Wu YJ, Su HT, Sun SF, Tuan SH. Using Virtual Reality-Based Rehabilitation in Sarcopenic Older Adults in Rural Health Care Facilities-A Quasi-Experimental Study. J Aging Phys Act. 2021 Oct 1;29(5):866-877. doi: 10.1123/japa.2020-0222. Epub 2021 Feb 16.

  PMID: 33596540 RESULT

• Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.

  PMID: 19588334 RESULT

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  PMID: 32033882 RESULT

• Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.

  PMID: 12028177 RESULT

• Ali S, Garcia JM. Sarcopenia, cachexia and aging: diagnosis, mechanisms and therapeutic options - a mini-review. Gerontology. 2014;60(4):294-305. doi: 10.1159/000356760. Epub 2014 Apr 8.

  PMID: 24731978 RESULT

• Frontera WR, Hughes VA, Fielding RA, Fiatarone MA, Evans WJ, Roubenoff R. Aging of skeletal muscle: a 12-yr longitudinal study. J Appl Physiol (1985). 2000 Apr;88(4):1321-6. doi: 10.1152/jappl.2000.88.4.1321.

  PMID: 10749826 RESULT

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Sheng-Hui Tuan, M.D.;Ph.D.

  Cishan Hospital, Ministry of Health and Welfare, Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Hui Tuan, M.D.;Ph.D.

CONTACT

+886-7-6613811; pj73010@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 6, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)