Functional Exercise for Sarcopenia (STEP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Behavioral: Functional Exercise; Behavioral: Education

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Ling Hu, Ph.D; Phone Number: 3057 886-3-211-8800; Email: huy@cgu.edu.tw
• Study Contact Backup: Name: Jamie Hsu, BS; Phone Number: 3057 886-3-211-8800; Email: m1106203@cgu.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 242
    • Active, not recruiting
    • Pei Ai holistic care association
  • New Taipei City, Taiwan
    • Active, not recruiting
    • Silver Care Association
  • Taoyuan, Taiwan
    • Active, not recruiting
    • Chinese e-touch community service association
  • Taoyuan, Taiwan
    • Active, not recruiting
    • Family Caregiver Care Association
  • Taoyuan, Taiwan
    • Active, not recruiting
    • Social Service Care Association (Guishan District)
  • Taoyuan, Taiwan
    • Active, not recruiting
    • Waishe community association
  • Taoyuan, Taiwan
    • Recruiting
    • Zhongshan community association
    • Contact: SHU-LING CHIU; Phone Number: 03-322-2617

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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.	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.
Sham Comparator: Control; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: community; older adult; habit; functional exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 202201076B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No