- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919486
Visual Feedback Non-weight Bearing Exercise on the Elderly With Knee Osteoarthritis.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan
- Recruiting
- Taipei
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Contact:
- Chueh.ho Lin
- Phone Number: 0977188356
- Email: chueh.ho@tmu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of degenerative knee arthritis.
- Must be able to stand up and sit down.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experiment group
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.
|
the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
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ACTIVE_COMPARATOR: elastic band exercise
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.
|
the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MicroFets3 to measure hip and knee muscle strength
Time Frame: 20 minutes
|
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.
|
20 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201908020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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