The Effect of Functional Exercise Interventions for Older Adults With Sarcopenia: A Hybrid Approach Study Aiming for Community Implementation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sarcopenia
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 60
- Locations
- 7
- Primary Endpoint
- Change of muscle mass in 12 weeks and 3 and 6 month follow-ups
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Sarcopenia is one of the major causes of functional decline and negative health outcomes among older adults. Prominent evidence suggests exercise interventions can reverse sarcopenia. However, past studies mainly focus on structured exercise programs, automatically excluding many older adults who are not motivated and lack the time/resources to conduct the structural exercise. Therefore, we propose to examine the effect of the Sarcopenia Translation functional Exercise Program (the STEP program) on community-dwelling older adults. The STEP is a functional exercise program designed to address low motivation and other time/resources barriers for rapid translation in community settings. The 12-week STEP program teaches older adults to apply functional exercise activities incorporating resistant training principles in their daily routines.
With a dual focus apriori in assessing clinical effectiveness and potential implementation strategies for future community implementations, we will conduct a single-blind randomized control trial among 60 community-dwelling older adults at risk or with sarcopenia. The study's purposes are threefold: (1) to assess the effect of the functional exercise intervention compared to usual care on primary outcomes of sarcopenia (muscle strength, muscle mass, and physical function); (2) to assess the long-term effects of the functional exercise intervention on primary outcomes of sarcopenia; (3) explore potential implementation strategies for rapid community implementation including development of a communityappropriate protocol for tracking long-term effects such as metabolomic biomarkers. This study aims to develop an effective functional exercise program as an alternative to structured exercise programs. Additionally, the goal is to accelerate the translation of the functional exercise program for older adults at risk or with sarcopenia in real-world settings.
Investigators
Yi-Ling Hu
Assistant Professor
Chang Gung Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- •age 65 or older
- •reside in northern Taiwan
- •at risk of /with sarcopenia determined by AWGS diagnostic guidelines
Exclusion Criteria
- •meets physical activity guidelines for older adults: conduct at least 150 minutes of moderate-intensity activity or 75 minutes of vigorous-intensity activity weekly
- •needs 24-hour resistance for the activity of daily living activities
- •has severe knee or back pain
- •severely impaired mobility or wheelchair bounded (ruling out possible secondary sarcopenia patients)
- •unstable cardiac conditions such as ventricular dysrhythmias, pulmonary edema, or other musculoskeletal conditions
- •impaired cognition (Mini-Mental State Examination \[MMSE\] score \< 24, or \<17 for participants with lower education level)
- •has a metal clip, implant, or pacemaker
Outcomes
Primary Outcomes
Change of muscle mass in 12 weeks and 3 and 6 month follow-ups
Time Frame: From baseline to 6 month follow-up
Skeletal muscle mass will be measured by a portable Bio-impedance analysis (BIA) instrument at 50hz (Yida muscle mass and strength analyzer; YD01A), which had preliminary valid data for Taiwanese older adults and can be easily carried to community settings.
Change of skeletal muscle strength in 12 weeks and 3 and 6 month follow-ups
Time Frame: From baseline to 6 month follow-up
Using a handheld dynamometer (MicroFET2, MMT) to measure the maximal isometric knee strength of the dominant leg with a standardized protocol.
The Reach, Adoption, Adherence and Fidelity of this research.
Time Frame: From baseline to 6 month follow-up
Reach includes recruitment and retention rates. Adoption will be surveyed among participants and service networks at post-test. Adherence will be measured by the average number of activities recorded in the STEP activity planner. Fidelity is defined as treatment delivery, treatment receipt, and treatment enactment.
Change of physical performance in 12 weeks and 3 and 6 month follow-ups
Time Frame: From baseline to 6 month follow-up
The Short Physical Performance Battery (SPPB) is an assessment of lower extremity function with three subtests: (1) standing balance, (2) four-meter gait speed, and (3) five repetitions of sit-to-stand motion.
Secondary Outcomes
- Change of quality of life in 12 weeks and 3 and 6 month follow-ups(From baseline to 6 month follow-up)
- Change of exercise habit in 12 weeks and 3 and 6 month follow-ups(From baseline to 6 month follow-up)
- Change of sedentary time in 12 weeks and 3 and 6 month follow-ups(From baseline to 6 month follow-up)