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A Study of the Intervention Effect of a Hybrid Exercise Program on Elderly With Sarcopenia

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
self-determine sequence exercise program
resistance training
Taichi exercise and resistance training
Randomly selected exercise program
Sponsored by
Northeast Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sarcopenia focused on measuring sarcopenia, elderly, exercise program, explainable artificial intelligence

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: satisfied the Asian screening criteria for sarcopenia by the Asian Working Group for Sarcopenia; age higher than 60 but less than 75 years of age. Exclusion Criteria: with serious illness or breathing failure; with neuro-muscular diseases; taking medication that has an effect on the function of skeletal muscles; with conditions relating to the neurological system or the mental health; in another scheduled training plan.

Sites / Locations

  • Chinese Center of Exercise Epidemiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

No Intervention

Experimental

Experimental

Arm Label

self-determine sequence exercise program

resistance training

control group

Taichi exercise and resistance training

Randomly selected exercise program

Arm Description

The trial was divided into three cycles, and participants were allowed to choose any one of the a Taichi exercise program, a hybrid program of Taichi exercise and resistance training programs, and resistance training as their intervention content before the start of each cycle. Participants who chose Taichi exercise performed one hour of Taichi exercise for each session, while participants who chose a hybrid exercise program of Taichi exercise and resistance training completed Taichi exercise in the first half hour and resistance training for the second half hour. Participants who chose resistance training performed one hour of resistance training. One hour per training session, three times a week for 24 weeks

Resistance strength training for resistance exercise and aimed at promoting the greatest hypertrophy response. Training is divided into three cycles, with progressive training load. Resistance exercise intervention three times a week for 24 weeks, one hour each time.

The participants in the control group were introduced by nurses to education about sarcopenia and various methods for preventing it, such as consuming more protein through their diet and participating in greater physical exercise.

The trial was divided into three cycles, each lasting eight weeks. Participants performed a hybrid program of Taichi exercise and resistance training of varying duration and intensity in each cycle. Each session lasted one hour, three times a week for 24 weeks.

The trial was divided into three cycles, and participants were allowed to choose any one of the a Yijinjing exercise program, a hybrid program of Yijinjing exercise and resistance training programs, and resistance training as their intervention content before the start of each cycle. Participants who chose Yijinjing exercise performed one hour of Yijinjing exercise for each session, while participants who chose a hybrid exercise program of Yijinjing exercise and resistance training completed Yijinjing exercise in the first half hour and resistance training for the second half hour. Participants who chose resistance training performed one hour of resistance training. One hour per training session, three times a week for 24 weeks

Outcomes

Primary Outcome Measures

Using quantitative CT to investigate the change of skeletal muscle area in sarcopenic elderly.
Participants will receive quantitative CT scans before and after the intervention to assess the change from baseline skeletal muscle area at 6 months.
Using a Jamar hydraulic hand dynamometer to investigate change of handgrip in sarcopenic elderly.
Participants will receive a handgrip strength test before and after the intervention to assess the change from baseline handgrip strength at 6 months.
Using a bioelectrical impedance body composition analyzer with a multifrequency device to investigate the change of relative skeletal muscle mass index in sarcopenic elderly.
Participants will receive a relative skeletal muscle mass index test before and after the intervention to assess the change from baseline relative skeletal muscle index at 6 months.

Secondary Outcome Measures

Collect participants' self-evaluation of their life state and physical state.
Participants were asked to write a self-assessment report of no more than 500 words before and after the intervention, including physical status and life status.
Collect video of participants throughout the intervention.
The entire intervention process was videotaped and video of the entire intervention process was collected from the participants.

Full Information

First Posted
January 11, 2023
Last Updated
February 6, 2023
Sponsor
Northeast Normal University
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1. Study Identification

Unique Protocol Identification Number
NCT05694117
Brief Title
A Study of the Intervention Effect of a Hybrid Exercise Program on Elderly With Sarcopenia
Official Title
White Box Modeling of Self-Determine Sequence Exercise Program Among Sarcopenic Elderly: Uncovers a Novel Strategy Overcoming Decline of Skeletal Muscle Area
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northeast Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Sarcopenia is a geriatric condition characterized by a progressive decrease in skeletal muscle content and loss of muscle function. Resistance exercise, Taichi exercise and the hybrid exercise program consisting of the two aforementioned methods have been demonstrated could increase the skeletal muscle mass of the elderly with sarcopenia. However, note that the above contents may be performed in a different order in a treatment, equally important but less well understood is the sequence in which it should be performed. Surprisingly, the exercise sequence has not been comprehensively investigated. Therefore, investigators designed a self-ordered exercise program combining resistance exercise, tai chi and a hybrid exercise program to investigate whether the decline in skeletal muscle area could be better overcome and the reversal of sarcopenia in elderly with sarcopenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, elderly, exercise program, explainable artificial intelligence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
self-determine sequence exercise program
Arm Type
Experimental
Arm Description
The trial was divided into three cycles, and participants were allowed to choose any one of the a Taichi exercise program, a hybrid program of Taichi exercise and resistance training programs, and resistance training as their intervention content before the start of each cycle. Participants who chose Taichi exercise performed one hour of Taichi exercise for each session, while participants who chose a hybrid exercise program of Taichi exercise and resistance training completed Taichi exercise in the first half hour and resistance training for the second half hour. Participants who chose resistance training performed one hour of resistance training. One hour per training session, three times a week for 24 weeks
Arm Title
resistance training
Arm Type
Experimental
Arm Description
Resistance strength training for resistance exercise and aimed at promoting the greatest hypertrophy response. Training is divided into three cycles, with progressive training load. Resistance exercise intervention three times a week for 24 weeks, one hour each time.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The participants in the control group were introduced by nurses to education about sarcopenia and various methods for preventing it, such as consuming more protein through their diet and participating in greater physical exercise.
Arm Title
Taichi exercise and resistance training
Arm Type
Experimental
Arm Description
The trial was divided into three cycles, each lasting eight weeks. Participants performed a hybrid program of Taichi exercise and resistance training of varying duration and intensity in each cycle. Each session lasted one hour, three times a week for 24 weeks.
Arm Title
Randomly selected exercise program
Arm Type
Experimental
Arm Description
The trial was divided into three cycles, and participants were allowed to choose any one of the a Yijinjing exercise program, a hybrid program of Yijinjing exercise and resistance training programs, and resistance training as their intervention content before the start of each cycle. Participants who chose Yijinjing exercise performed one hour of Yijinjing exercise for each session, while participants who chose a hybrid exercise program of Yijinjing exercise and resistance training completed Yijinjing exercise in the first half hour and resistance training for the second half hour. Participants who chose resistance training performed one hour of resistance training. One hour per training session, three times a week for 24 weeks
Intervention Type
Behavioral
Intervention Name(s)
self-determine sequence exercise program
Intervention Description
The Taichi exercise utilized the simplified eight styles of Taichi. The resistance training program consisted of three cycles. In the first cycle, investigators used a light load but high repetitions (ranging from 40% to 60% of one repetition maximum and 12-20 repetitions). During the second phase of our training, investigators raised the training load by doing sets of moderate intensity and a medium number of repetitions (ranging from 60% to 80% of one repetition maximum and 5-12 repetitions). In the third cycle, investigators aimed to improve the participants' maximal muscular resistance by using a greater training load and fewer repetitions (ranging from 70% to 85% of one repetition maximum and 5-8 repetitions).
Intervention Type
Behavioral
Intervention Name(s)
resistance training
Intervention Description
The resistance training program consisted of three cycles. In the first cycle, investigators used a light load but high repetitions (ranging from 40% to 60% of one repetition maximum and 12-20 repetitions). During the second phase of our training, investigators raised the training load by doing sets of moderate intensity and a medium number of repetitions (ranging from 60% to 80% of one repetition maximum and 5-12 repetitions). In the third cycle, investigators aimed to improve the participants' maximal muscular resistance by using a greater training load and fewer repetitions (ranging from 70% to 85% of one repetition maximum and 5-8 repetitions). Participants in the RTG completed four sets of each movement, with two to three minutes of rest between each set.
Intervention Type
Behavioral
Intervention Name(s)
Taichi exercise and resistance training
Intervention Description
The training of the Taichi exercise and resistance training group consisted of two cycles, the first cycle was aimed at learning and consolidating Taichi exercise, and the second cycle was aimed at improving and consolidating. The Taichi exercise and resistance training group was scheduled for 30 min of Taichi exercise per training. The resistance training program consisted of three cycles. In the first cycle, investigators used a light load but high repetitions (ranging from 40% to 60% of one repetition maximum and 12-20 repetitions). During the second phase of our training, investigators raised the training load by doing sets of moderate intensity and a medium number of repetitions (ranging from 60% to 80% of one repetition maximum and 5-12 repetitions). In the third cycle, investigators aimed to improve the participants' maximal muscular resistance by using a greater training load and fewer repetitions (ranging from 70% to 85% of one repetition maximum and 5-8 repetitions).
Intervention Type
Behavioral
Intervention Name(s)
Randomly selected exercise program
Intervention Description
Participants in the randomly selected exercise program group who chose Yijinjing exercise were required to complete one hour of Yijinjing exercise training, and those who chose Yijinjing exercise hybrid strength training had to complete half an hour of Yijinjing training. The resistance training program consisted of three cycles. In the first cycle, investigators used a light load but high repetitions (ranging from 40% to 60% of one repetition maximum and 12-20 repetitions). During the second phase of our training, investigators raised the training load by doing sets of moderate intensity and a medium number of repetitions (ranging from 60% to 80% of one repetition maximum and 5-12 repetitions). In the third cycle, investigators aimed to improve the participants' maximal muscular resistance by using a greater training load and fewer repetitions (ranging from 70% to 85% of one repetition maximum and 5-8 repetitions).
Primary Outcome Measure Information:
Title
Using quantitative CT to investigate the change of skeletal muscle area in sarcopenic elderly.
Description
Participants will receive quantitative CT scans before and after the intervention to assess the change from baseline skeletal muscle area at 6 months.
Time Frame
Month 6
Title
Using a Jamar hydraulic hand dynamometer to investigate change of handgrip in sarcopenic elderly.
Description
Participants will receive a handgrip strength test before and after the intervention to assess the change from baseline handgrip strength at 6 months.
Time Frame
Month 6
Title
Using a bioelectrical impedance body composition analyzer with a multifrequency device to investigate the change of relative skeletal muscle mass index in sarcopenic elderly.
Description
Participants will receive a relative skeletal muscle mass index test before and after the intervention to assess the change from baseline relative skeletal muscle index at 6 months.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Collect participants' self-evaluation of their life state and physical state.
Description
Participants were asked to write a self-assessment report of no more than 500 words before and after the intervention, including physical status and life status.
Time Frame
Month 6
Title
Collect video of participants throughout the intervention.
Description
The entire intervention process was videotaped and video of the entire intervention process was collected from the participants.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: satisfied the Asian screening criteria for sarcopenia by the Asian Working Group for Sarcopenia; age higher than 60 but less than 75 years of age. Exclusion Criteria: with serious illness or breathing failure; with neuro-muscular diseases; taking medication that has an effect on the function of skeletal muscles; with conditions relating to the neurological system or the mental health; in another scheduled training plan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Yang
Organizational Affiliation
Chinese Center of Exercise Epidemiology
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese Center of Exercise Epidemiology
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130024
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of the Intervention Effect of a Hybrid Exercise Program on Elderly With Sarcopenia

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