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

The Short Effectiveness of Self-Management Skills and Health Promotion Programs on the Health Status of the Pre-frail Individuals in the Communities

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.

Study Overview

• Status: Completed
• Conditions: Older Adults
• Intervention / Treatment: Behavioral: multicomponent exercise training program

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 Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Taoyuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unconscious
• Cognitive impairment or dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks	Behavioral: multicomponent exercise training program; One supervised 60 minutes training sessions per week were organized combining warm-up, speed-walking, resistance exercise, static and dynamic balance. Supervised walking sessions were for 10-20 minutes at a target intensity of 13-15 on the Borg scale. Thereafter, 10 resistance exercises targeting lower body, trunk and upper body muscles were performed with elastic band. In addition, participants were instructed to accumulate 150 minutes per week of moderate intensity aerobic activity in bouts of at least 10 minutes, and at least 2-3 days all major muscle groups training.
No Intervention: control arm; The control arm received an education leaflet.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shu-Hung Chang
• Collaborators: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Shu-Hung Chang, Ph. D, Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; older adults; multicomponent exercise training; physical performance; Pre-frailty; Coronavirus Disease 2019 pandemic
• Other Study ID Numbers: ZRRPF3J0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No