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Clinical Trials/NCT05476471
NCT05476471CompletedNot Applicable

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

Shu-Hung Chang1 site in 1 country169 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
169
Locations
1
Primary Endpoint
Frailty

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
60 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Unconscious
  • •Cognitive impairment or dementia

Arms & Interventions

intervention arm

Experimental

The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks

Intervention: multicomponent exercise training program (Behavioral)

control arm

No Intervention

The control arm received an education leaflet.

Outcomes

Primary Outcomes

Frailty

Time Frame: 4 month follow up

Frailty measurement used study of osteoporotic fracture index (SOF)

Physical activity

Time Frame: 4 month follow up

International Physical Activity Questionnaire (IPAQ)

short physical performance battery

Time Frame: 4 month follow up

sit-to-stand, standing balance, and gait-speed

Secondary Outcomes

  • physical agility and dynamic balance ability(4 month follow up)
  • upper limb muscle strength(4 month follow up)
  • static balance ability(4 month follow up)

Investigators

Sponsor
Shu-Hung Chang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Shu-Hung Chang

Professor

Chang Gung University of Science and Technology

Study Sites (1)

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