OsteoarthritisNCT04919486
Visual Feedback Non-weight Bearing Exercise on the Elderly With Knee Osteoarthritis.
A study testing visual feedback with non-weight bearing exercise and elastic band exercise in people with Osteoarthritis, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Degenerative knee arthritis is the most common chronic arthritis disease. Once the elderly suffer from this disease, it will accelerate the loss of body function and autonomy. strength performances and maintain are the most important functional performances of lower extremities, especially in walking and balance in… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- visual feedback with non-weight bearing exercise and elastic band exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jul 2020to 25 Jul 2021
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Clinical diagnosis of degenerative knee arthritis.
- Must be able to stand up and sit down.
Who cannot join
- surgery on the knee or hip joint.
- rheumatoid arthritis and uarthritis in past six years.
- lower limb fractures
- neurological diseases,e.g.,stroke、parkinson's disease
- injected hyaluronic acid into the knee joint in the past two months
- severe cardiovascular and heart failure.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei
Taipei
Chueh.ho Lin, 0977188356, chueh.ho@tmu.edu.tw
About this study
Official title: Investigating the Impacts of Visual Feedback Non-weight Bearing Exercise on Muscle Strength and Physical Fitness of Lower Limbs in Elderly People With Knee Osteoarthritis in the Community.
Degenerative knee arthritis is the most common chronic arthritis disease. Once the elderly suffer from this disease, it will accelerate the loss of body function and autonomy. strength performances and maintain are the most important functional performances of lower extremities, especially in walking and balance in daily activities for elderly people with osteoarthritis(OA) of the knee. However, combining the exercise and visual feedback may promote the muscle strength and functional performances of lower limbs, facilitating the muscle strength, motor and boady functional performances for elderly adults after OA knee. Therefore, the purpose of this proposal is to investigate the changes in muscle strength and physical fitness of lower limbs in older adults following OA knee after visual feedback non-weight bearing exercise intervention.
Read the detailed description
Backgroud:In clinical observation, aging leads to a gradual degeneration of the neuromuscular system, decreasing the muscle strength and functional performances of lower extremities. Muscle strength performances and maintain are the most important functional performances of lower extremities, especially in walking and balance in daily activities for elderly people with osteoarthritis(OA) of the knee. However, non-weight bearing exercise combing visual feedback may promote functional performances of lower limbs, facilitating the muscle strength for elderly people with OA knee.
Purpose: Therefore, the purpose of this proposal is to promote muscle strength and physical fitness after visual feedback non-weight bearing exercise intervention.
Method:After recruiting 40 elderly people with degenerative knee arthritis, they were randomly assigned to the experimental group and the control group .The experimental group conducted visual feedback under the guidance of Labview software, and used rowing machine equipment for resistance exercise training.The training time of the two groups is 12 weeks, twice a week, 30 minutes each time, a total of 24 times.Before and after exercise training , both groups used the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to understand their self-response of knee(pain、stiffness functional)；used MicroFets3 to measure hip and knee muscle strength；Elder Functional Fitness chose Chair stand test、Functional reach test、10m-Walking time are used to understand the body function.
Stastistical analysis:Data were analyzed with SPSS18.0. Paired Sample t-test and Independent-Sample T Test were used to determine the between-groupand within-group differences on all outcome measures. The statistical significance level was set at a (p<0.05).
- Conditions
- Osteoarthritis
- Being tested
- visual feedback with non-weight bearing exercise, elastic band exercise
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual feedback with non-weight bearing exerciseBehavioural
the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
elastic band exerciseBehavioural
the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | non-weight bearing visual feedback intervention under the of Labview software, and used rowing machine equipment for exercise training for 30 minutes,then eselastic band exercise training for 30 minutes. Receives: Behavioral: visual feedback with non-weight bearing exercise |
| elastic band exercise | Active comparator | elastic band exercise under the Physiotherapist, and used elastic band for exercise training for 60 minutes,include muscles flexion the hip joint, muscles extention the hip joint,etc. Receives: Behavioral: elastic band exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The scale is mainly to trace the patient's subjective perception of the knee joint within 48 hours. There are 24 questions, divided into three aspects: pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points) , Functional activities (17 questions, 0-68 points), each item is divided into five levels: none, minor, moderate, severe, and very severe. The total of the three parts is 0-96 points.
Measured: 5 minutes
Secondary outcomes (1)
MicroFets3 to measure hip and knee muscle strength
we Include Hip Abductor 、Hip adductors、Hip extensors、Hip flexors、knee extensors、knee flexors etc.Before the test, the subject practiced once and then performed a formal test. The strength of each muscle contraction was recorded in kilograms. During the formal test, the subject was required to resist MicroFET3 with maximum strength, and the tester gave the order (Strong! Push hard! Push hard!), the data uses the average of three times, and each muscle rests for one minutes.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start25 Jul 2020
- Primary completion25 Jul 2021 (estimated)
- Study completion25 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919486
- Sponsor's protocol ID
- N201908020
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2020
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin PL, Yu LF, Kuo SF, Wang XM, Lu LH, Lin CH. Effects of computer-aided rowing exercise systems on improving muscle strength and function in older adults with mild knee osteoarthritis: a randomized controlled clinical trial. BMC Geriatr. 2022 Oct 21;22(1):809. doi: 10.1186/s12877-022-03498-2.
PubMed 36266615
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impacts of Visual Feedback Non-weight Bearing Exercise on Muscle Strength and Physical Fitness of Lower Limbs in Elderly People With Knee Osteoarthritis in the Community.
- ClinicalTrials.gov ID
- NCT04919486
- Acronym / sponsor ID
- N201908020
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 25 Jul 2021 (estimated)
- Study completion
- 25 Jul 2021 (estimated)
- First posted
- 9 Jun 2021 (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.
Degenerative knee arthritis is the most common chronic arthritis disease. Once the elderly suffer from this disease, it will accelerate the loss of body function and autonomy. strength performances and maintain are the most important functional performances of lower extremities, especially in walking and balance in daily activities for elderly people with osteoarthritis(OA) of the knee. However, combining the exercise and visual feedback may promote the muscle strength and functional performances of lower limbs, facilitating the muscle strength, motor and boady functional performances for elderly adults after OA knee. Therefore, the purpose of this proposal is to investigate the changes in muscle strength and physical fitness of lower limbs in older adults following OA knee after visual feedback non-weight bearing exercise intervention.
Detailed description
Backgroud:In clinical observation, aging leads to a gradual degeneration of the neuromuscular system, decreasing the muscle strength and functional performances of lower extremities. Muscle strength performances and maintain are the most important functional performances of lower extremities, especially in walking and balance in daily activities for elderly people with osteoarthritis(OA) of the knee. However, non-weight bearing exercise combing visual feedback may promote functional performances of lower limbs, facilitating the muscle strength for elderly people with OA knee.
Purpose: Therefore, the purpose of this proposal is to promote muscle strength and physical fitness after visual feedback non-weight bearing exercise intervention.
Method:After recruiting 40 elderly people with degenerative knee arthritis, they were randomly assigned to the experimental group and the control group .The experimental group conducted visual feedback under the guidance of Labview software, and used rowing machine equipment for resistance exercise training.The training time of the two groups is 12 weeks, twice a week, 30 minutes each time, a total of 24 times.Before and after exercise training , both groups used the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to understand their self-response of knee(pain、stiffness functional)；used MicroFets3 to measure hip and knee muscle strength；Elder Functional Fitness chose Chair stand test、Functional reach test、10m-Walking time are used to understand the body function.
Stastistical analysis:Data were analyzed with SPSS18.0. Paired Sample t-test and Independent-Sample T Test were used to determine the between-groupand within-group differences on all outcome measures. The statistical significance level was set at a (p<0.05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Behavioral: visual feedback with non-weight bearing exercisenon-weight bearing visual feedback intervention under the of Labview software, and used rowing machine equipment for exercise training for 30 minutes,then eselastic band exercise training for 30 minutes. |
| elastic band exercise | Active comparator | Behavioral: elastic band exerciseelastic band exercise under the Physiotherapist, and used elastic band for exercise training for 60 minutes,include muscles flexion the hip joint, muscles extention the hip joint,etc. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of degenerative knee arthritis.
- Must be able to stand up and sit down.
Key exclusion criteria (6 listed)
- surgery on the knee or hip joint.
- rheumatoid arthritis and uarthritis in past six years.
- lower limb fractures
- neurological diseases,e.g.,stroke、parkinson's disease
- injected hyaluronic acid into the knee joint in the past two 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 |
|---|---|---|
| visual feedback with non-weight bearing exercisethe training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times. | Behavioural | Experiment group |
| elastic band exercisethe training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times. | Behavioural | elastic band exercise |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 5 minutes
The scale is mainly to trace the patient's subjective perception of the knee joint within 48 hours. There are 24 questions, divided into three aspects: pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points) , Functional activities (17 questions, 0-68 points), each item is divided into five levels: none, minor, moderate, severe, and very severe. The total of the three parts is 0-96 points.
1 secondary outcome
MicroFets3 to measure hip and knee muscle strength
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Derived from this study: PubMed 36266615Lin PL, Yu LF, Kuo SF, Wang XM, Lu LH, Lin CH. Effects of computer-aided rowing exercise systems on improving muscle strength and function in older adults with mild knee osteoarthritis: a randomized controlled clinical trial. BMC Geriatr. 2022 Oct 21;22(1):809. doi: 10.1186/s12877-022-03498-2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual feedback with non-weight bearing exercise and elastic band exercise in people with Osteoarthritis, run by Taipei Medical University 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chueh ho LIN (+886 977188356, chueh.ho@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919486, which also lists 1 linked publication.
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 9 Jun 2021.