Frail ElderlyNCT06672640
Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults
A study testing Remote Exercise Program, In-Person Exercise Program and Physical Activity Education in people with Frail Elderly, run by Kyungdong University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Remote Exercise Program, In-Person Exercise Program and Physical Activity Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Physical Therapy, Kyungdong University
Wŏnju, Gangwon-do, 26495
About this study
Official title: Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults: A Randomized Controlled Trial
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
- Being tested
- Remote Exercise Program, In-Person Exercise Program, Physical Activity Education
- Keywords
- Telerehabilitation, Postural balance, Gait, Frail Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Exercise ProgramBehavioural
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 ProgramBehavioural
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 EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| remote exercise group | Experimental | 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. Receives: Behavioral: Remote Exercise Program |
| in-person exercise group | Experimental | 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. Receives: Behavioral: In-Person Exercise Program |
| control group | Other | 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. Receives: Other: Physical Activity Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance ability
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.
Measured: Baseline and post-intervention at 8 weeks
Lower Limb Strength
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.
Measured: Baseline and post-intervention at 8 weeks
Gait Ability
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.
Measured: Baseline and post-intervention at 8 weeks
Fall Efficacy
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.
Measured: Baseline and post-intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungdong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyeongjin Lee, Kyungdong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672640
- Sponsor's protocol ID
- 2024-05-014
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06672640
- Acronym / sponsor ID
- 2024-05-014
- Conditions
- Frail Elderly
- Keywords
- Telerehabilitation, Postural balance, Gait, Frail Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kyungdong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| remote exercise group | Experimental | Behavioral: Remote Exercise ProgramParticipants 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. |
| in-person exercise group | Experimental | Behavioral: In-Person Exercise ProgramParticipants 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. |
| control group | Other | Other: Physical Activity EducationParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Exercise ProgramParticipants 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. | Behavioural | remote exercise group |
| In-Person Exercise ProgramParticipants 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. | Behavioural | in-person exercise group |
| Physical Activity EducationParticipants 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. | Other | control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Exercise Program, In-Person Exercise Program and Physical Activity Education in people with Frail Elderly, run by Kyungdong University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance ability (time frame: Baseline and post-intervention at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.