Effectiveness of RPT With Elastic Band in Tx of Sarcopenia in LTCFs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorCishan Hospital, Ministry of Health and Welfare
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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. -
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
elastic band
DeviceParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PRT with EBExperimental treatment 1 intervention
Group B: Standard care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.2
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
Time frame
From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.3
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.
Time frame
From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.4
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.
Time frame
From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.Secondary outcomes
1
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.
Time frame
From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.2
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.
Time frame
From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.3
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.
Time frame
From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.4
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.
Time frame
From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.Sponsors and contacts
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Source ClinicalTrials.gov