Exercise Intervention for Pre-frail Elderly

NCT ID: NCT06519695

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Older Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multicomponent exercises group

Multicomponent exercise intervention under the guidance of the wellness motivation theory

Group Type EXPERIMENTAL

Multicomponent exercises

Intervention Type BEHAVIORAL

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

Control group

Health education about exercise only once.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multicomponent exercises

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hangzhou Normal University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianping Ren

director of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ren Jianping

Role: PRINCIPAL_INVESTIGATOR

Hangzhou Normal University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 35231098 (View on PubMed)

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.

Reference Type RESULT
PMID: 26389979 (View on PubMed)

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.

Reference Type RESULT
PMID: 33189414 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39478450 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JRen

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Traditional Exercise RCT in Visually Impaired Adults
NCT07265024 ENROLLING_BY_INVITATION NA