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Completed

NCT Number: NCT06672640

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

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.

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Key information

Conditions

Frail Elderly

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Kyungdong University

Wŏnju, Gangwon-do, 26495, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Remote Exercise Program

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 Program

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.

Physical Activity Education

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Kyungdong University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

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.

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