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Active, not recruitingNCT06519695Updated Jul 31, 2024

Exercise Intervention for Pre-frail Elderly

An interventional study of Multicomponent exercises in Older Adults, sponsored by Hangzhou Normal University. Active, not recruiting at 1 site in China. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Hangzhou Normal University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jul 2022, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
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Study summary

The aim of this study is to evaluate the effectiveness of multicomponet exercise for reversing pre-frailty among Chinese community-dwelling pre-frail older adults.Meanwhile,to explore the effects of multicomponent exercise on self-efficiency of exercise.

Read the 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:

  1. 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.
  2. 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.
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Conditions studied

  • Older Adults

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Keywords

  • frail
  • exercise
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's enrollment of 144 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • physical restrictions to perform the tests and/or exercises,
  • cognitive impairment;
  • medical for participation in an exercise program.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    Multicomponent exercises group

    Multicomponent exercise intervention under the guidance of the wellness motivation theory

    Behavioral: Multicomponent exercises

  • No intervention
    Control group

    Health education about exercise only once.

Interventions

  • BehavioralMulticomponent exercises

    Performed exercise three times a week, one time at a community health service station and two times at home

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What researchers measure

Primary outcomes

  1. Reversal of pre-frailty

    Reversal rate of pre-frailty (from pre-frail to robust in this study)

    Time frame: 24 weeks

Secondary outcomes

  1. Self-efficacy for exercise

    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.

    Time frame: 24 weeks

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Study locations

1 site
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References and documents

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. PubMed 35231098 ↗
  • 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. PubMed 26389979 ↗
  • 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. PubMed 33189414 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06519695
Lead sponsor
Hangzhou Normal University
Responsible party
Jianping Ren (director of department, Hangzhou Normal University) — Principal investigator
First posted
Jul 25, 2024
Start date
Jul 1, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2024 (estimated)
Last update
Jul 31, 2024

Study contacts

Ren Jianping
principal investigator · Hangzhou Normal University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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