Skip to main content
OpenTrials
Completed

NCT Number: NCT05476471

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Older Adults Behavior Motor Activity

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taoyuan

Taoyuan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unconscious
  • Cognitive impairment or dementia

Treatment and study plan

multicomponent exercise training program

Behavioral

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.

Primary outcomes

  1. Physical activity

    Time frame: 4 month follow up

    International Physical Activity Questionnaire (IPAQ)

  2. short physical performance battery

    Time frame: 4 month follow up

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

  3. Frailty

    Time frame: 4 month follow up

    Frailty measurement used study of osteoporotic fracture index (SOF)

Secondary outcomes

  1. upper limb muscle strength

    Time frame: 4 month follow up

    hand-grip strength

  2. static balance ability

    Time frame: 4 month follow up

    single-leg standing with the eyes open

  3. physical agility and dynamic balance ability

    Time frame: 4 month follow up

    Timed-Up and Go and Functional Reach Test

Sponsors and collaborators

Lead sponsor

Shu-Hung Chang

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2022
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.