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Functional Exercise for Sarcopenia (STEP)

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Enrolling

Conditions

Sarcopenia

Treatments

Behavioral: Education
Behavioral: Functional Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05570136
202201076B0

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Treatment
Experimental group
Description:
Participants in the treatment group will receive the 12-week STEP by a trained interventionist. In the first four weeks, the interventionist will focus on building participants' selfefficacy and health literacy and help participants learn the STEP exercise and principles. In the following four weeks, the interventionist will help the older adults to be more independent in prescribing exercise activities for themselves. In the last four weeks, participants will be fulling knowledgeable and independent on functional exercising; the interventionist will allocate community resources for long-term maintenance. After program completion, trained raters will administer at post-tests. There will also be a 3-month and 6-month follow-up evaluation after program completion.
Treatment:
Behavioral: Functional Exercise
Control
Sham Comparator group
Description:
Participants in the control group will receive weekly health newsletters and will not get any suggestions or encouragement to do exercise from the research team. A staff member will call the control group participants weekly to document any new exercise programs from usual community services. At this stage, participants will not be excluded from the study if they join an exercise program, but we will document what kind of exercise they are conducting. Trained raters will administer at post-tests and two follow-ups.
Treatment:
Behavioral: Education

Trial contacts and locations

7

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Central trial contact

Jamie Hsu, BS; Yi-Ling Hu, Ph.D

Data sourced from clinicaltrials.gov

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