Effectiveness of Individual Physical Activity Programs to Prevent Sarcopenia and Frailty Among Older Adults

Study Overview
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Brief Summary
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Sarcopenia and frailty could be prevented and rehabilitated through individual physical activities in the form of combined exercise that could be practiced at home in daily life.

Detailed Description
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The volunteers were randomly assigned to either the intervention or control group using sealed envelopes containing documents marked with either IG (intervention group) or CG (control group). The intervention group received training, after which they demonstrated and practiced the physical activities. They were provided with an exercise leaflet for self-practice at home and were followed up by phone, LINE application, and leaders of social club for older adults at least once a week to ensure regular practice. The older adults' relatives and caregivers were also trained and encouraged to practice with them in a 1:1 match. Support techniques and warning signs for stopping or taking a break during exercise were added to each posture, along with suggestions for suitable environmental management, such as flat plains, sufficient light, and no barriers within 2 meters, to reduce the risks of accidents. However, the control group did not receive any intervention apart from general suggestions and continued with their usual daily activities.

Official Title
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Effectiveness of Individual Physical Activity Programs to Prevent and Slow Progression of Sarcopenia and Frailty Among Thai Community-dwelling Older Adults: A Double-blind Randomized Clinical Trial

Conditions
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Sarcopenia, Frailty

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged between 60 and 80 years. Those who are able to walk independently or with the aid of walking devices. Exclusion Criteria: Participants with leg or foot amputations. Participants who had been admitted to hospitals in the past 6 months. Those with underlying medical conditions such as heart disease, bone and muscle injuries, and infectious diseases. Individuals who did not pass the Physical Activity Readiness Questionnaire (PAR-Q).

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The Experimental groups or physical activity groups were assigned to three groups based on their muscle mass: normal, probable sarcopenia, and sarcopenia groups. The volunteers were provided with instructions on individual physical activities to be practiced at home for 30 weeks, 2-5 days per week and 50 minutes per session. These physical activities consisted of flexibility exercise for 10 minutes, aerobic exercise for 20 minutes, and resistance exercise for 20 minutes, as outlined in supplement 1. The volunteers were instructed on exercise techniques and physical activities by either sports scientists or registered nurses, and caregivers such as relatives or staff from the social club for older adults were allowed to be present during practice. | Behavioral: Physical activity<br>* resistance, aerobic, and flexibility exercises<br>|
| No Intervention: Control<br>The control group did not receive any intervention apart from general suggestions and continued with their usual daily activities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The status of sarcopenia aligns with the criteria set by the Asian Working Group for Sarcopenia (AWGS). | Sarcopenia status was assessed through three aspects, including a muscle strength test using handgrip strength measured with a dynamometer, a physical performance test using the Short Physical Performance Battery (SPPB), and an appendicular skeletal muscle mass (ASM) test measured with the ACCUNIQ BC 380 tool based on bioelectrical impedance analysis (BIA). The results were aligned with the standards set by the Asian Working Group for Sarcopenia (AWGS). Sarcopenia was diagnosed by low ASM with low muscle strength or low physical performance, dynapenia was diagnosed by low muscle strength only, and pre-sarcopenia was diagnosed by low ASM or low physical performance. Participants underwent assessments both at the beginning and at the 30-week endpoint. | 30 weeks | 
| Muscle strength | Muscle strength, specifically handgrip strength, was measured using a hand-held dynamometer. Participants gripped the dynamometer with their dominant hand while standing, maintaining their upper arm close to the body and their elbow bent to 90 degrees, exerting maximum force. This test was conducted twice, and the superior result was recorded. Low muscle strength was diagnosed if the handgrip strength was < 26 kilograms in males and < 18 kilograms in females. Participants underwent assessments at both the beginning and the 30-week endpoint. | 30 weeks | 
| Physical performance | The physical performance test utilized the Short Physical Performance Battery (SPPB) to evaluate physical function, with a maximum score of 12 points. Low physical performance was diagnosed if the SPPB score was ≤ 9. Participants underwent assessments at both the beginning and the 30-week endpoint. | 30 weeks | 
| Muscle mass | Appendicular skeletal muscle mass (ASM) was measured using the ACCUNIQ BC 380 tool based on bioelectrical impedance analysis (BIA), and the Skeletal Muscle Mass Index (SMI) was calculated by dividing ASM in kilograms by the height in meters squared. Low muscle mass is diagnosed if SMI is < 7.0 kilograms/meter^2 in men and < 5.47 kg/m^2 in women. Participants underwent assessments at both the beginning and the 30-week endpoint. | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical frailty status based on the 5 criteria of frailty phenotype, as defined by Fried et al. 2001. | Frailty phenotype assessment followed Fried et al.'s (2001) criteria, including weakness, slowness, unintentional weight loss, exhaustion, and low physical activity. Participants were categorized as frail if they met three or more criteria, pre-frail with one or two, and robust if none were fulfilled. (i) Weakness: Handgrip strength measured with a dynamometer. (ii) Slowness: Assessed by the time taken in a 15-feet walk test. (iii) Unintentional Weight Loss: Evaluated by recording weight loss exceeding 10 pounds or 5% in the last 3 months. (iv) Exhaustion: Assessed with two questions from the CES-D depression scale. (v) Low Physical Activity: Determined by asking about the frequency of moderate physical activities in the past week. Participants underwent assessments at both the beginning and the 30-week endpoint. | 30 weeks |