Functional Exercise for Sarcopenia

Sarcopenia Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570136
• Other study ID #: 202201076B0
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: Yi-Ling Hu, Ph.D
• Phone: 886-3-211-8800
• Email: huy[@]cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Behavioral:
• Functional Exercise
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.
• Education
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.

Locations

Country	Name	City	State
Taiwan	Pei Ai holistic care association	New Taipei City
Taiwan	Silver Care Association	New Taipei City
Taiwan	Chinese e-touch community service association	Taoyuan
Taiwan	Family Caregiver Care Association	Taoyuan
Taiwan	Social Service Care Association (Guishan District)	Taoyuan
Taiwan	Waishe community association	Taoyuan
Taiwan	Zhongshan community association	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of skeletal muscle strength in 12 weeks and 3 and 6 month follow-ups	Using a handheld dynamometer (MicroFET2, MMT) to measure the maximal isometric knee strength of the dominant leg with a standardized protocol.	From baseline to 6 month follow-up
Primary	Change of muscle mass in 12 weeks and 3 and 6 month follow-ups	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.	From baseline to 6 month follow-up
Primary	Change of physical performance in 12 weeks and 3 and 6 month follow-ups	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.	From baseline to 6 month follow-up
Primary	The Reach, Adoption, Adherence and Fidelity of this research.	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.	From baseline to 6 month follow-up
Secondary	Change of exercise habit in 12 weeks and 3 and 6 month follow-ups	Self-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.	From baseline to 6 month follow-up
Secondary	Change of sedentary time in 12 weeks and 3 and 6 month follow-ups	Participants 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.	From baseline to 6 month follow-up
Secondary	Change of quality of life in 12 weeks and 3 and 6 month follow-ups	The 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.	From baseline to 6 month follow-up