The Effectiveness of Health Promotion Programs on the Pre-frail Individuals

Not Applicable

Completed

• Conditions: Older Adults
• Interventions: Behavioral: multicomponent exercise training program

• Registration Number: NCT05476471
• Lead Sponsor: Shu-Hung Chang

Brief Summary

This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.

Detailed Description

This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.

Design: A two-arm parallel cluster randomized controlled trial. Older adults ≥60 years old were recruited from eight community units in northern Taiwan. One-hundred and sixty-seven eligible subjects consented to participate in the study. Community units were randomly assigned to either an intervention arm (n=82) or a control arm (n=87). The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet. Assessments were performed at baseline and 16 weeks for physical activity, physical performance, and pre-frailty rate. Analysis of covariance or chi-square test adjusted for pretest evaluated the differences between the two study arms.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-05-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-25
• Last Update Submitted: 2022-07-25
• Study First Posted: 2022-07-27
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• older adult with age ≥ 60 years
• community-dwelling
• no hearing and visual acuity difficulties

Exclusion Criteria

• Unconscious
• Cognitive impairment or dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention arm	multicomponent exercise training program	The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks

Primary Outcome Measures

Name	Time	Method
Frailty	4 month follow up	Frailty measurement used study of osteoporotic fracture index (SOF)
Physical activity	4 month follow up	International Physical Activity Questionnaire (IPAQ)
short physical performance battery	4 month follow up	sit-to-stand, standing balance, and gait-speed

Secondary Outcome Measures

Name	Time	Method
physical agility and dynamic balance ability	4 month follow up	Timed-Up and Go and Functional Reach Test
upper limb muscle strength	4 month follow up	hand-grip strength
static balance ability	4 month follow up	single-leg standing with the eyes open

Trial Locations

Locations (1)

Taoyuan; 🇨🇳 Taoyuan, Taiwan