Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults

NCT ID: NCT06672640

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-31

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.

Conditions

Frail Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

remote exercise group

Participants in the remote exercise group will engage in exercise sessions conducted twice weekly for eight weeks using video conferencing software. The intervention includes balance, strength, and gait training, supervised by a licensed physical therapist. Sessions are performed at participants' homes with assistance from caregivers to ensure safety and compliance.

Group Type: EXPERIMENTAL

Remote Exercise Program

Intervention Type: BEHAVIORAL

Participants in this group will engage in an eight-week exercise program conducted via video conferencing software. The sessions, which focus on balance, lower limb strength, and gait function, will be held twice weekly for 50 minutes each. Licensed physical therapists will supervise the sessions, and participants will exercise at home, with assistance from caregivers if necessary. The program aims to evaluate the effectiveness of remote exercise interventions in improving physical function and reducing the risk of falls in pre-frail older adults.

in-person exercise group

Participants in the in-person exercise group will attend supervised exercise sessions at a senior welfare center twice weekly for eight weeks. The sessions, conducted by a licensed physical therapist, focus on improving balance, lower limb strength, and gait stability. The intervention is identical to the remote exercise group, except the mode of delivery is in person at the welfare center.

Group Type: EXPERIMENTAL

In-Person Exercise Program

Intervention Type: BEHAVIORAL

Participants in this group will take part in an eight-week in-person exercise program at a senior welfare center. The sessions will be held twice weekly for 50 minutes and will be led by a licensed physical therapist. The exercise program, which includes balance, lower limb strength, and gait training, is identical to that of the remote exercise group, with the primary difference being the mode of delivery (in-person at the welfare center). This group aims to assess the effectiveness of direct supervision in a controlled environment.

control group

Participants in the control group will receive an informational booklet on exercise and attend a single educational session about physical activity. They will be encouraged to maintain their usual activities, and their physical activity levels will be self-reported and periodically monitored by the research team.

Group Type: OTHER

Physical Activity Education

Intervention Type: OTHER

Participants in this group will receive educational materials about physical activity, including a booklet and one educational session. They will not participate in any structured exercise program but will be encouraged to maintain their usual activities. The control group serves as a baseline to compare the outcomes of exercise interventions against no structured exercise, focusing on evaluating usual care versus targeted exercise programs.

Interventions

Remote Exercise Program

Participants in this group will engage in an eight-week exercise program conducted via video conferencing software. The sessions, which focus on balance, lower limb strength, and gait function, will be held twice weekly for 50 minutes each. Licensed physical therapists will supervise the sessions, and participants will exercise at home, with assistance from caregivers if necessary. The program aims to evaluate the effectiveness of remote exercise interventions in improving physical function and reducing the risk of falls in pre-frail older adults.

Intervention Type: BEHAVIORAL

In-Person Exercise Program

Participants in this group will take part in an eight-week in-person exercise program at a senior welfare center. The sessions will be held twice weekly for 50 minutes and will be led by a licensed physical therapist. The exercise program, which includes balance, lower limb strength, and gait training, is identical to that of the remote exercise group, with the primary difference being the mode of delivery (in-person at the welfare center). This group aims to assess the effectiveness of direct supervision in a controlled environment.

Intervention Type: BEHAVIORAL

Physical Activity Education

Participants in this group will receive educational materials about physical activity, including a booklet and one educational session. They will not participate in any structured exercise program but will be encouraged to maintain their usual activities. The control group serves as a baseline to compare the outcomes of exercise interventions against no structured exercise, focusing on evaluating usual care versus targeted exercise programs.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungdong University

OTHER

Sponsor Role: lead

Responsible Party

Kyeongjin Lee

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Physical Therapy, Kyungdong University

Wŏnju, Gangwon-do, South Korea

Countries

South Korea

Other Identifiers

2024-05-014

Identifier Type: -

Identifier Source: org_study_id