Clinical trial NCT05570136: Functional Exercise for Sarcopenia
Official title: The Effect of Functional Exercise Interventions for Older Adults With Sarcopenia: A Hybrid Approach Study Aiming for Community Implementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: habit
community
older adult
functional exercise
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment group will receive functional exercise intervention, and the sham control group will receive weekly newsletters and phone calls.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. age 65 or older
2. reside in northern Taiwan
3. at risk of /with sarcopenia determined by AWGS diagnostic guidelines

Exclusion Criteria:

1. meets physical activity guidelines for older adults: conduct at least 150 minutes of moderate-intensity activity or 75 minutes of vigorous-intensity activity weekly
2. needs 24-hour resistance for the activity of daily living activities
3. has severe knee or back pain
4. severely impaired mobility or wheelchair bounded (ruling out possible secondary sarcopenia patients)
5. unstable cardiac conditions such as ventricular dysrhythmias, pulmonary edema, or other musculoskeletal conditions
6. impaired cognition (Mini-Mental State Examination \[MMSE\] score \< 24, or \<17 for participants with lower education level)
7. has a metal clip, implant, or pacemaker

Primary outcomes:
measure: Change of skeletal muscle strength in 12 weeks and 3 and 6 month follow-ups
timeFrame: From baseline to 6 month follow-up
measure: Change of muscle mass in 12 weeks and 3 and 6 month follow-ups
timeFrame: From baseline to 6 month follow-up
measure: Change of physical performance in 12 weeks and 3 and 6 month follow-ups
timeFrame: From baseline to 6 month follow-up
measure: The Reach, Adoption, Adherence and Fidelity of this research.
timeFrame: From baseline to 6 month follow-up
Secondary outcomes:
measure: Change of exercise habit in 12 weeks and 3 and 6 month follow-ups
timeFrame: From baseline to 6 month follow-up
measure: Change of sedentary time in 12 weeks and 3 and 6 month follow-ups
timeFrame: From baseline to 6 month follow-up
measure: Change of quality of life in 12 weeks and 3 and 6 month follow-ups
timeFrame: From baseline to 6 month follow-up
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Pei Ai holistic care association
city: New Taipei City
country: Taiwan
facility: Silver Care Association
city: Taoyuan
country: Taiwan
facility: Chinese e-touch community service association
city: Taoyuan
country: Taiwan
facility: Family Caregiver Care Association
city: Taoyuan
country: Taiwan
facility: Social Service Care Association (Guishan District)
city: Taoyuan
country: Taiwan
facility: Waishe community association
city: Taoyuan
country: Taiwan
facility: Zhongshan community association
Study officials:
References: