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Clinical Trials/NCT06672640
NCT06672640
Completed
Not Applicable

Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults: A Randomized Controlled Trial

Kyungdong University1 site in 1 country90 target enrollmentJune 1, 2023
ConditionsFrail Elderly

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frail Elderly
Sponsor
Kyungdong University
Enrollment
90
Locations
1
Primary Endpoint
Balance ability
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aims to compare the effects of remote versus in-person exercise interventions on physical function, balance, gait stability, and fall efficacy in pre-frail older adults aged 65 years and above. Participants are randomly assigned to either a remote exercise group, an in-person exercise group, or a control group. The exercise intervention includes balance, strength, and gait training conducted twice weekly for eight weeks. The control group receives educational materials on physical activity. The primary outcome measures include assessments of balance, lower limb strength, gait ability, and fall efficacy. This study seeks to determine if remote exercise is as effective as in-person exercise in enhancing physical function in pre-frail older adults, potentially providing a feasible alternative to traditional in-person programs and addressing barriers such as limited mobility and access to exercise facilities.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kyungdong University
Responsible Party
Principal Investigator
Principal Investigator

Kyeongjin Lee

professor

Kyungdong University

Eligibility Criteria

Inclusion Criteria

  • Aged 65 years or older
  • Classified as pre-frail based on Fried's frailty criteria (meeting at least two out of five specified indicators)
  • Experienced a fall in the preceding six months or have impaired gait and balance (TUG ≥ 13.5 seconds, BBS ≤ 45)
  • Mini-Mental State Examination (MMSE) score of 24 or higher
  • Demonstrate the physical capacity to engage in the remote exercise (e.g., ability to stand from a seated position and walk short distances)

Exclusion Criteria

  • Neurological or musculoskeletal conditions that impede physical activity
  • Recent history of severe cardiovascular disease (within the past three months)
  • Inability to commit to continuous participation throughout the study period
  • Any other medical condition that might interfere with the intervention or pose a risk to the participant

Outcomes

Primary Outcomes

Balance ability

Time Frame: Baseline and post-intervention at 8 weeks

Balance performance will be assessed using the Timed Up and Go (TUG) test and Berg Balance Scale (BBS). The TUG measures the time taken for a participant to stand up from a chair, walk three meters, turn around, walk back, and sit down. The BBS is a comprehensive assessment of balance ability during various tasks.

Lower Limb Strength

Time Frame: Baseline and post-intervention at 8 weeks

Lower limb strength will be evaluated using the Five Times Sit-to-Stand Test (FTSTS) and the 30-Second Chair Stand Test (30SCS). The FTSTS measures the time it takes for participants to rise from a chair five times, and the 30SCS measures the number of times participants can rise from a chair in 30 seconds.

Gait Ability

Time Frame: Baseline and post-intervention at 8 weeks

Gait ability will be assessed using the Dynamic Gait Index (DGI) and the 10-Meter Walk Test (10MWT). The DGI assesses participants' ability to modify balance while walking in response to external demands, and the 10MWT measures the time taken to walk 10 meters at a comfortable speed.

Fall Efficacy

Time Frame: Baseline and post-intervention at 8 weeks

Fall efficacy will be measured using the Modified Falls Efficacy Scale (MFES). This scale evaluates participants' confidence in performing daily activities without falling, providing an indication of fall-related self-efficacy.

Study Sites (1)

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