Visual Feedback Non-weight Bearing Exercise on the Elderly With Knee Osteoarthritis.
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
visual feedback with non-weight bearing exercise
elastic band exercise
Sponsored by
About this trial
This is an interventional prevention trial for Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- TaipeiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experiment group
elastic band exercise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04919486
Brief Title
Visual Feedback Non-weight Bearing Exercise on the Elderly With Knee Osteoarthritis.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2020 (Actual)
Primary Completion Date
July 25, 2021 (Anticipated)
Study Completion Date
July 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment group
Arm Type
Experimental
Arm Description
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.
Arm Title
elastic band exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
visual feedback with non-weight bearing exercise
Intervention Description
the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
Intervention Type
Behavioral
Intervention Name(s)
elastic band exercise
Intervention Description
the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
MicroFets3 to measure hip and knee muscle strength
Description
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.
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chueh ho LIN
Phone
+886 977188356
Email
chueh.ho@tmu.edu.tw
Facility Information:
Facility Name
Taipei
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chueh.ho Lin
Phone
0977188356
Email
chueh.ho@tmu.edu.tw
12. IPD Sharing Statement
Citations:
PubMed Identifier
36266615
Citation
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.
Results Reference
derived
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Visual Feedback Non-weight Bearing Exercise on the Elderly With Knee Osteoarthritis.
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