NCT05476471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

July 22, 2022

Last Update Submit

July 25, 2022

Conditions

Keywords

multicomponent exercise trainingolder adultsphysical activityphysical performancePre-frailtyCoronavirus Disease 2019 pandemic

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • upper limb muscle strength

    4 month follow up

  • static balance ability

    4 month follow up

  • physical agility and dynamic balance ability

    4 month follow up

Study Arms (2)

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

Behavioral: multicomponent exercise training program

control arm

NO INTERVENTION

The control arm received an education leaflet.

Interventions

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.

intervention arm

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unconscious
  • Cognitive impairment or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan

Taoyuan District, Taiwan

Location

Related Publications (1)

  • Chang SH, Chiang CC, Chien NH. Efficacy of a multicomponent exercise training program intervention in community-dwelling older adults during the COVID-19 pandemic: A cluster randomized controlled trial. Geriatr Nurs. 2023 Jan-Feb;49:148-156. doi: 10.1016/j.gerinurse.2022.11.019. Epub 2022 Dec 16.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Shu-Hung Chang, Ph. D

    Chang Gung University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 27, 2022

Study Start

January 1, 2020

Primary Completion

January 1, 2020

Study Completion

May 31, 2020

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations