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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT with EB | Experimental | LTCFs users who receive standard care plus progressive resistance training with elastic band |
|
| Standard care group | No Intervention | LTCFs users who receive only standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| maximal voluntary isometric contraction of biceps brachii/ triceps brachii/ quadriceps muscle | In this study, the maximal voluntary isometric contraction (MVIC) strength of the dominant biceps brachii, triceps brachii, and quadriceps muscle are measured using the MicroFET3 device (Hoggan, Health Industrial, UT, USA) under standardized posture. The average of two measurements of each muscle is recorded as the participant's MVIC strength. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng-Hui Tuan, M.D.;Ph.D. | Contact | +886-7-6613811 | 3101 | pj73010@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheng-Hui Tuan, M.D.;Ph.D. | Cishan Hospital, Ministry of Health and Welfare, Kaohsiung, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CiShan hospital, MOHW | Recruiting | Kaohsiung City | 842 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26467494 | Background | 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. | |
| 36649288 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2025 | Apr 3, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2025 | Apr 3, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention. |
| 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 | In this study, a portable ultrasound device, equipped with a 12 MHz linear probe, is used for measurements. All measurements are performed under the same parameter settings by a physician with years of clinical ultrasound experience. The measurement of the biceps brachii muscle is conducted with the participant in a supine position, the upper limb extended and fully relaxed. The probe is positioned at two-thirds of the distance from the acromion to the anterior elbow crease along the line connecting these two points. The probe is placed gently in a transverse orientation, and the measurement range is defined as the distance between the lower edge of the subcutaneous fat and the most prominent point of the humerus. | 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 | In this study, a portable ultrasound device, equipped with a 12 MHz linear probe, is used for measurements. All measurements are performed under the same parameter settings by a physician with years of clinical ultrasound experience. The measurement of the quadriceps muscle is conducted with participants in a supine position, with both lower limbs extended and fully relaxed. The probe is placed at the midpoint of the line connecting the anterior superior iliac spine (ASIS) and the superior border of the patella (see illustration on the left). The thickness of the quadriceps muscle is defined as the sum of the thickness of the rectus femoris and vastus intermedius muscles, measured in a transverse scan. | 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 | In this study, a portable ultrasound device, equipped with a 12 MHz linear probe, is used for measurements. All measurements are performed under the same parameter settings by a physician with years of clinical ultrasound experience. The measurement of the gastrocnemius muscle is performed with participants in a prone position, both legs extended and relaxed, with the feet hanging off the edge of the examination table. The examiner places the ultrasound probe close to the skin, ensuring the probe beam is perpendicular to the skin surface. The medial cross-sectional area of the medial head of the gastrocnemius muscle is identified, with the largest cross-sectional area selected as the standard imaging plane, and the corresponding skin surface location is marked. Measurements include: 1. Fat thickness (FT): The distance from the superficial fascia to the skin. 2. Muscle thickness (MT): The distance from the superficial fascia to the deep fascia. | From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention. |
| hand dexterity | This study utilizes the Box and Block Test (BBT) for the objective assessment of hand dexterity. Participants are instructed to use their dominant hand to transfer blocks, one at a time, from a box on the same side, across a central partition, and into a box on the opposite side. During the test, participants must ensure that only one block is moved at a time and that all blocks must cross the partition. The number of blocks successfully transferred within 1 minute is recorded, with a higher count indicating better hand function. | From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention. |
| Calf Circumference | The measurement of calf circumference (CC) is conducted bilaterally, including the paretic and non-paretic sides of stroke patients. Participants are positioned in either a seated or supine posture, with the knees and hips flexed at 90°, and the feet naturally placed on the floor or bed, with the ankles relaxed. The examiner faces the participant and identifies the largest circumference of the calf on both sides. A flexible tape measure is used to measure CC, ensuring it is positioned perpendicular to the axis of the calf. The measurement error is kept below 0.1 cm. To minimize the influence of edema, measurements are performed in the morning. Each leg is measured twice, and the highest value is recorded. | From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention. |
| EQ-5D questionnaire | The EQ-5D is a widely used health-related quality of life assessment tool suitable for evaluating functional outcomes in stroke patients. It covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension includes three to five response options, reflecting varying levels of health status. | From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention. |
| Mini Nutritional Assessment | The Mini Nutritional Assessment (MNA) is a comprehensive nutritional evaluation tool designed to assess various aspects of a patient's condition over the past three months, including dietary intake, mobility, upper arm circumference, and calf circumference. The MNA consists of 18 items divided into two main sections: nutritional screening and general assessment. The total score ranges from 0 to 30. | From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention. |
| 26655368 | 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. |
| 31343601 | 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. |
| 33902464 | 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. |
| 29638028 | 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. |
| 33596540 | 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. |
| 19588334 | 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. |
| 32033882 | 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. |
| 12028177 | 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. |
| 24731978 | 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. |
| 10749826 | 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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |