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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04919486
Other study ID # N201908020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 25, 2020
Est. completion date July 25, 2021

Study information

Verified date July 2020
Source Taipei Medical University
Contact Chueh ho LIN
Phone +886 977188356
Email chueh.ho@tmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 25, 2021
Est. primary completion date July 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
visual feedback with non-weight bearing exercise
the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
elastic band exercise
the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.

Locations

Country Name City State
Taiwan Taipei Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 minutes
Secondary 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. 20 minutes
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