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Functional Exercise for Sarcopenia (STEP)

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Functional Exercise
Education
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring habit, community, older adult, functional exercise

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pei Ai holistic care associationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 4, 2022
Last Updated
September 6, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05570136
Brief Title
Functional Exercise for Sarcopenia
Acronym
STEP
Official Title
The Effect of Functional Exercise Interventions for Older Adults With Sarcopenia: A Hybrid Approach Study Aiming for Community Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
habit, community, older adult, functional exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The treatment group will receive functional exercise intervention, and the sham control group will receive weekly newsletters and phone calls.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Functional Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of skeletal muscle strength in 12 weeks and 3 and 6 month follow-ups
Description
Using a handheld dynamometer (MicroFET2, MMT) to measure the maximal isometric knee strength of the dominant leg with a standardized protocol.
Time Frame
From baseline to 6 month follow-up
Title
Change of muscle mass in 12 weeks and 3 and 6 month follow-ups
Description
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.
Time Frame
From baseline to 6 month follow-up
Title
Change of physical performance in 12 weeks and 3 and 6 month follow-ups
Description
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.
Time Frame
From baseline to 6 month follow-up
Title
The Reach, Adoption, Adherence and Fidelity of this research.
Description
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.
Time Frame
From baseline to 6 month follow-up
Secondary Outcome Measure Information:
Title
Change of exercise habit in 12 weeks and 3 and 6 month follow-ups
Description
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.
Time Frame
From baseline to 6 month follow-up
Title
Change of sedentary time in 12 weeks and 3 and 6 month follow-ups
Description
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.
Time Frame
From baseline to 6 month follow-up
Title
Change of quality of life in 12 weeks and 3 and 6 month follow-ups
Description
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.
Time Frame
From baseline to 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 65 or older reside in northern Taiwan at risk of /with sarcopenia determined by AWGS diagnostic guidelines Exclusion Criteria: meets physical activity guidelines for older adults: conduct at least 150 minutes of moderate-intensity activity or 75 minutes of vigorous-intensity activity weekly needs 24-hour resistance for the activity of daily living activities has severe knee or back pain severely impaired mobility or wheelchair bounded (ruling out possible secondary sarcopenia patients) unstable cardiac conditions such as ventricular dysrhythmias, pulmonary edema, or other musculoskeletal conditions impaired cognition (Mini-Mental State Examination [MMSE] score < 24, or <17 for participants with lower education level) has a metal clip, implant, or pacemaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ling Hu, Ph.D
Phone
886-3-211-8800
Ext
3057
Email
huy@cgu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Hsu, BS
Phone
886-3-211-8800
Ext
3057
Email
m1106203@cgu.edu.tw
Facility Information:
Facility Name
Pei Ai holistic care association
City
New Taipei City
ZIP/Postal Code
242
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YEN-TZU CHEN
Phone
02-29031191

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional Exercise for Sarcopenia

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