- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06519695
Exercise Intervention for Pre-frail Elderly
A Study on the Exercise Intervention Mode of Modern Exercises and Traditional Chinese Exercises for the Community-Dwelling Pre-frail Elderly: Based on the Wellness Motivation Theory
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Based on the Wellness Motivation Theory (WMT), this study aimed to develop a theoretical model of exercise intervention for the pre-frail elderly. This study was to establish an exercise intervention mode, conduct empirical research through randomized controlled trials, and propose improvement strategies, aiming at improving the effectiveness of health management services for the community-dwelling pre-frail elderly. Specific research objectives are as follows:
- To develop a theoretical model of exercise intervention for the pre-frail elderly based on the WMT, and to explain the operation mechanism of the exercise intervention mode.
- An empirical study was conducted to verify the applicability and effectiveness of the exercise intervention mode, analyze the influencing factors of the intervention effect, and propose optimization strategies to improve the exercise intervention effect of the elderly in pre-frailty.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 311121
- Hangzhou Normal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- community-dwelling prefrail older adults based on Fried frailty phenotype;
- age≥60 years,≤85 years;
- not engaged in regular physical activity or exercise programs in the previous 6 months;
- no hearing or visual impairment that might hinder communication;
- Written informed consent.
Exclusion Criteria:
- physical restrictions to perform the tests and/or exercises,
- cognitive impairment;
- medical contraindications for participation in an exercise program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multicomponent exercises group
Multicomponent exercise intervention under the guidance of the wellness motivation theory
|
Performed exercise three times a week, one time at a community health service station and two times at home
|
|
No Intervention: Control group
Health education about exercise only once.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reversal of pre-frailty
Time Frame: 24 weeks
|
Reversal rate of pre-frailty (from pre-frail to robust in this study)
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy for exercise
Time Frame: 24 weeks
|
The Self-Efficacy for Exercise Scale was designed to test people's confidence to continue exercising despite barriers to exercise.
The score of each item ranged from 0 to 10, with higher scores representing greater exercise self-efficacy.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ren Jianping, Hangzhou Normal University
Publications and helpful links
General Publications
- Dun Y, Hu P, Ripley-Gonzalez JW, Zhou N, Li H, Zhang W, Chen M, Zheng Q, Cui N, Wu S, Liu S. Effectiveness of a multicomponent exercise program to reverse pre-frailty in community-dwelling Chinese older adults: a randomised controlled trial. Age Ageing. 2022 Mar 1;51(3):afac026. doi: 10.1093/ageing/afac026.
- McMahon SK, Wyman JF, Belyea MJ, Shearer N, Hekler EB, Fleury J. Combining Motivational and Physical Intervention Components to Promote Fall-Reducing Physical Activity Among Community-Dwelling Older Adults: A Feasibility Study. Am J Health Promot. 2016 Nov;30(8):638-644. doi: 10.4278/ajhp.130522-ARB-265. Epub 2016 Jun 16.
- Barrachina-Igual J, Martinez-Arnau FM, Perez-Ros P, Flor-Rufino C, Sanz-Requena R, Pablos A. Effectiveness of the PROMUFRA program in pre-frail, community-dwelling older people: A randomized controlled trial. Geriatr Nurs. 2021 Mar-Apr;42(2):582-591. doi: 10.1016/j.gerinurse.2020.10.014. Epub 2020 Nov 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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