NCT06519695

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 19, 2024

Last Update Submit

July 29, 2024

Conditions

Older Adults

Keywords

frailexercise

Outcome Measures

Primary Outcomes (1)

  • Reversal of pre-frailty

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

    24 weeks

Secondary Outcomes (1)

  • Self-efficacy for exercise

    24 weeks

Study Arms (2)

Multicomponent exercises group

EXPERIMENTAL

Multicomponent exercise intervention under the guidance of the wellness motivation theory

Behavioral: Multicomponent exercises

Control group

NO INTERVENTION

Health education about exercise only once.

Interventions

Multicomponent exercisesBEHAVIORAL

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

Multicomponent exercises group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • physical restrictions to perform the tests and/or exercises,
  • cognitive impairment;
  • medical contraindications for participation in an exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Normal University

Hangzhou, Zhejiang, 311121, China

Location

Related Publications (4)

  • 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.

    PMID: 35231098RESULT

  • 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.

    PMID: 26389979RESULT

  • 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.

    PMID: 33189414RESULT

  • Fang J, Ren J, Wang J, Qiu X, Zhang S, Yuan S, Wu L, Xie L. Combining motivational and exercise intervention components to reverse pre-frailty and promote self-efficacy among community-dwelling pre-frail older adults: a randomized controlled trial. BMC Geriatr. 2024 Oct 30;24(1):896. doi: 10.1186/s12877-024-05464-6.

    PMID: 39478450DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ren Jianping

    Hangzhou Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of department

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 25, 2024

Study Start

July 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)