Clinical trial NCT06519695: Exercise Intervention for Pre-frail Elderly
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Older Adults
Keywords: frail
exercise
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 144
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reversal of pre-frailty
timeFrame: 24 weeks
Secondary outcomes:
measure: Self-efficacy for exercise
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: Hangzhou Normal University
name: Ren Jianping
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.