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

Older Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05476471
• Other study ID #: ZRRPF3J0031
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2022
• Source: Chang Gung University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: May 31, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• older adult with age = 60 years

• community-dwelling

• no hearing and visual acuity difficulties

Exclusion Criteria:

• Unconscious

• Cognitive impairment or dementia

Related Conditions & MeSH terms

• Older Adults

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taoyuan	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Shu-Hung Chang	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	International Physical Activity Questionnaire (IPAQ)	4 month follow up
Primary	short physical performance battery	sit-to-stand, standing balance, and gait-speed	4 month follow up
Primary	Frailty	Frailty measurement used study of osteoporotic fracture index (SOF)	4 month follow up
Secondary	upper limb muscle strength	hand-grip strength	4 month follow up
Secondary	static balance ability	single-leg standing with the eyes open	4 month follow up
Secondary	physical agility and dynamic balance ability	Timed-Up and Go and Functional Reach Test	4 month follow up