AgingNCT05790369
Effects of Home-Based Ankle Training Program on The Muscle Strength, Balance and Gait Function in the Elderly
A study testing Resistance training (New ankle machine training) and Resistance training (Elastic band training ) in people with Aging, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The occurrence of frequent falls influences the independence of the elderly's physical functions, and the factors related to falls include: weakness in the lower limbs, age, past injury experiences and so forth. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Resistance training (New ankle machine training) and Resistance training (Elastic band training )
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2021to 8 Jan 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy elderly people over 65 years old have no exercise habits.
- The ability to walk independently or without equipment is at least 10m.
- Able to independently perform activities related to daily life, such as doing housework, walking, climbing stairs, etc.
- Elderly people who have a history of minor stroke or upper limb surgery but have not affected the ankle movement can be included in the scope of the case.
Who cannot join
- There is a musculoskeletal system disease, or the movement of the limbs is severely restricted.
- If there is a history of lower limb surgery, which affects neurological symptoms and mobility, it is excluded.
- Exclude specific diseases, such as stroke, spinal cord injury,etc., who have obvious sequelae of movement.
- Participated in other programs including Muscular strength, Balance ability, Gait function training, etc. in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The occurrence of frequent falls influences the independence of the elderly's physical functions, and the factors related to falls include: weakness in the lower limbs, age, past injury experiences and so forth. Prolonged inactivity also increases the risk of falls, which is subsequently prone to bringing about other complications, which enhances the odds of falling again on the elderly.
In the literature, training methods for the lower limbs were for the most part of complex training, whereas only a few studied on the single part training. In locomotion, the ankle first touches the ground, needing strong ankle muscular strength to support the body. Nevertheless, previous studies rarely mentioned whether a single ankle muscular strength could reduce the risk of falls.
Read more
Traditionally, the training of ankle muscular strength practically utilizes elastic bands, and there are plenty of benefits confirmed in the literature. However, it is even harder to implement the operation in reality, especially in the elderly. To resolve this problem effectively, a new type of ankle training machine is added to this study. It can be adjusted to different levels of resistance, provide multi directional training, and allow the subjects to be trained in a sitting position achieving a stable state. In addition, this machine is easy to operate for the elderly.
The aims of this research are: (1) to propose two different types of ankle training methods and designed a 6 week training programs, (2) to explore whether the training programs can improve muscular strength, balance capacity and gait function and (3) compare the training effects between the two types of ankle training methods. In this study, 60 voluntary old citizens, aged over 65, will be recruited, and they will be randomly divided into: 30 members in the Elastic Band Training Group (EBTG) and 30 members in the New Ankle Training Machine Training Group (NAMTG). During the six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks; meanwhile, coaches can affirm whether the plan is executed properly, confirming the effectiveness of the home training. Through these two groups of home ankle training programs with different interventional approaches lasting six weeks, the objective of the intervention is to boost muscular strength, balance ability as well as gait ability, meanwhile to decline the risk of falls and to reduce high medical expenses and care labor costs.
- Conditions
- Aging
- Being tested
- Resistance training (New ankle machine training), Resistance training (Elastic band training )
- Keywords
- Ankle strengthening training, Muscular strength, Balance ability, Gait function, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training (New ankle machine training)Behavioural
A six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks.
Resistance training (Elastic band training )Behavioural
A six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| New ankle machine training group (NAMTG) | Experimental | home-based ankle training program consisted of 6 exercises for their general physical fitness and use a device (new ankle machine) to provide progressive resisted exercise for the ankle strength Receives: Behavioral: Resistance training (New ankle machine training) |
| Elastic band training group (EBTG) | Active comparator | home-based ankle training program consisted of 6 exercises for their general physical fitness and use Thera band to provide progressive resisted exercise for the ankle strength Receives: Behavioral: Resistance training (Elastic band training ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength test
Sit-to-stand test, recoding by the time in seconds
Measured: Change from Baseline (before the training) at the completion of 6 weeks training
Postural stability test
One-leg standing with eye-open and eye-closed, recoding by the the center of pressure from a force plate
Measured: Change from Baseline (before the training) at the completion of 6 weeks training
Y- balance test
Recoding the distance in the anterior, posterio-medial and posterio-lateral in cm.
Measured: Change from Baseline (before the training) at the completion of 6 weeks training
Gait analysis
Recoding the joint angle in degrees by the IMU sensors.
Measured: Change from Baseline (before the training) at the completion of 6 weeks training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start9 Dec 2021
- Primary completion8 Jan 2023
- Study completion8 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiu-Chen Lin, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790369
- Sponsor's protocol ID
- CMUH110-REC2-192
- Status last verified
- May 2023
- First submitted
- 20 Oct 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-Based Ankle Training Program on The Muscle Strength, Balance and Gait Function in the Elderly
- ClinicalTrials.gov ID
- NCT05790369
- Acronym / sponsor ID
- CMUH110-REC2-192
- Conditions
- Aging
- Keywords
- Ankle strengthening training, Muscular strength, Balance ability, Gait function, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 8 Jan 2023 (actual)
- Study completion
- 8 Jan 2023 (actual)
- First posted
- 30 Mar 2023 (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.
The occurrence of frequent falls influences the independence of the elderly's physical functions, and the factors related to falls include: weakness in the lower limbs, age, past injury experiences and so forth. Prolonged inactivity also increases the risk of falls, which is subsequently prone to bringing about other complications, which enhances the odds of falling again on the elderly.
In the literature, training methods for the lower limbs were for the most part of complex training, whereas only a few studied on the single part training. In locomotion, the ankle first touches the ground, needing strong ankle muscular strength to support the body. Nevertheless, previous studies rarely mentioned whether a single ankle muscular strength could reduce the risk of falls.
Traditionally, the training of ankle muscular strength practically utilizes elastic bands, and there are plenty of benefits confirmed in the literature. However, it is even harder to implement the operation in reality, especially in the elderly. To resolve this problem effectively, a new type of ankle training machine is added to this study. It can be adjusted to different levels of resistance, provide multi directional training, and allow the subjects to be trained in a sitting position achieving a stable state. In addition, this machine is easy to operate for the elderly.
The aims of this research are: (1) to propose two different types of ankle training methods and designed a 6 week training programs, (2) to explore whether the training programs can improve muscular strength, balance capacity and gait function and (3) compare the training effects between the two types of ankle training methods. In this study, 60 voluntary old citizens, aged over 65, will be recruited, and they will be randomly divided into: 30 members in the Elastic Band Training Group (EBTG) and 30 members in the New Ankle Training Machine Training Group (NAMTG). During the six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks; meanwhile, coaches can affirm whether the plan is executed properly, confirming the effectiveness of the home training. Through these two groups of home ankle training programs with different interventional approaches lasting six weeks, the objective of the intervention is to boost muscular strength, balance ability as well as gait ability, meanwhile to decline the risk of falls and to reduce high medical expenses and care labor costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New ankle machine training group (NAMTG) | Experimental | Behavioral: Resistance training (New ankle machine training)home-based ankle training program consisted of 6 exercises for their general physical fitness and use a device (new ankle machine) to provide progressive resisted exercise for the ankle strength |
| Elastic band training group (EBTG) | Active comparator | Behavioral: Resistance training (Elastic band training )home-based ankle training program consisted of 6 exercises for their general physical fitness and use Thera band to provide progressive resisted exercise for the ankle strength |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Healthy elderly people over 65 years old have no exercise habits.
- The ability to walk independently or without equipment is at least 10m.
- Able to independently perform activities related to daily life, such as doing housework, walking, climbing stairs, etc.
- Elderly people who have a history of minor stroke or upper limb surgery but have not affected the ankle movement can be included in the scope of the case.
Key exclusion criteria (4 listed)
- There is a musculoskeletal system disease, or the movement of the limbs is severely restricted.
- If there is a history of lower limb surgery, which affects neurological symptoms and mobility, it is excluded.
- Exclude specific diseases, such as stroke, spinal cord injury,etc., who have obvious sequelae of movement.
- Participated in other programs including Muscular strength, Balance ability, Gait function training, etc. in the past 6 months
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 |
|---|---|---|
| Resistance training (New ankle machine training)A six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks. | Behavioural | New ankle machine training group (NAMTG) |
| Resistance training (Elastic band training )A six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks. | Behavioural | Elastic band training group (EBTG) |
Primary outcome
Muscle strength test
Time frame: Change from Baseline (before the training) at the completion of 6 weeks training
Sit-to-stand test, recoding by the time in seconds
Postural stability test
Time frame: Change from Baseline (before the training) at the completion of 6 weeks training
One-leg standing with eye-open and eye-closed, recoding by the the center of pressure from a force plate
Y- balance test
Time frame: Change from Baseline (before the training) at the completion of 6 weeks training
Recoding the distance in the anterior, posterio-medial and posterio-lateral in cm.
Gait analysis
Time frame: Change from Baseline (before the training) at the completion of 6 weeks training
Recoding the joint angle in degrees by the IMU sensors.
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 11 May 2023.
- Individual participant dataSharing planned: No
Related trials for Aging
Recruiting
Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study
Aging, Dementia
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Plant-based Diet in Older People: What Consequences for Muscle Health?
Aging
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 Resistance training (New ankle machine training) and Resistance training (Elastic band training ) in people with Aging, run by China Medical University Hospital at 1 site in Taiwan.
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 4 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 11 May 2023. 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 Taiwan. 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?
Muscle strength test (time frame: Change from Baseline (before the training) at the completion of 6 weeks training). 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 11 May 2023.