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Functional Exercise for Sarcopenia

The Effect of Functional Exercise Interventions for Older Adults With Sarcopenia: A Hybrid Approach Study Aiming for Community Implementation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05570136
Acronym
STEP
Enrollment
60
Registered
2022-10-06
Start date
2022-10-15
Completion date
2025-12-30
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

habit, community, older adult, functional exercise

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.

Interventions

Treatment group will receive the 12-week STEP by a trained interventionist. During the intervention period, an occupational therapist will help the participant to learn the STEP exercise and principles and help the older adults to be more independent on functional exercising.

BEHAVIORALEducation

In the education group, participant will receive weekly health newsletters containing general health aging materials. A staff member will call the control group participants weekly to document any new exercise programs from usual community services.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

The treatment group will receive functional exercise intervention, and the sham control group will receive weekly newsletters and phone calls.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of skeletal muscle strength in 12 weeks and 3 and 6 month follow-upsFrom baseline to 6 month follow-upUsing a handheld dynamometer (MicroFET2, MMT) to measure the maximal isometric knee strength of the dominant leg with a standardized protocol.
Change of muscle mass in 12 weeks and 3 and 6 month follow-upsFrom baseline to 6 month follow-upSkeletal 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 physical performance in 12 weeks and 3 and 6 month follow-upsFrom baseline to 6 month follow-upThe 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.
The Reach, Adoption, Adherence and Fidelity of this research.From baseline to 6 month follow-upReach 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.

Secondary

MeasureTime frameDescription
Change of sedentary time in 12 weeks and 3 and 6 month follow-upsFrom baseline to 6 month follow-upParticipants will wear an ActiGraph accelerometer over the right hip on an elasticized belt for seven days after the consent visit. Participants will be asked to wear the accelerometer throughout the day except swimming, showering, or bathing.
Change of quality of life in 12 weeks and 3 and 6 month follow-upsFrom baseline to 6 month follow-upThe Chinese The World Health Organization Quality of Life-Brief assessment (WHOQoL-BREF) is a validated measure that assesses physical, psychological, social relationships, and environmental quality of life.
Change of exercise habit in 12 weeks and 3 and 6 month follow-upsFrom baseline to 6 month follow-upSelf-Reported Habit Index (SRHI), a self-rated assessment, which incorporates constructs such as habit strength, frequency, relevance to self-identity, and automaticity. Higher scores indicate that behavior is more strongly habitual.

Countries

Taiwan

Contacts

Primary ContactYi-Ling Hu, Ph.D
huy@cgu.edu.tw886-3-211-8800
Backup ContactJamie Hsu, BS
m1106203@cgu.edu.tw886-3-211-8800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026