The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis, Arthropathy of Knee Joint
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.
Exclusion Criteria:
- The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
Sites / Locations
- Sports Medicine Center, Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Exercise
Arm Description
Standard rehabilitation procedure
Aerobic exercise combined with resistance training; Concentric resistance training; Eccentric resistance training
Outcomes
Primary Outcome Measures
Change from baseline muscle mass
Muscle mass measurement is measured by dual-energy x-ray absorptiometry (DXA). DXA measures the muscle mass of the whole body and the measurement is assessed at pre-operation, three months, six months and nine months after the operation, and twelve-month follow-up.
Secondary Outcome Measures
Change from baseline lower extremity muscle strength
Lower extremity muscle strength, including extension and flexion of the hip, knee and ankle were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min. The participants are assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up and received verbal encouragement during the exertion of peak torque.
Motion analysis
Gait analysis by VICON three-dimensional, 8-camera motion capture system.The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Change from baseline SF-36 questionnaire assessment
SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower score the more disability. The higher the score the less disability. Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score. The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Change from baseline KOOS questionnaire assessment
KOOS contains 5 subscales with a total of 42 items: 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation and 5) knee-related quality of life. Each question receives a score from 0 to 4 and the scores are transformed to a 0-100 score (0, extreme symptoms, 100, no symptoms). The User's Guide, is available from www.koos.nu. The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Physical fitness---6-minutes' walk test
The 6-minutes' walk test measures the distance an individual is able to walk over a total of 6 minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Physical fitness---8 feet up and go
The 8 feet up and go test indicates the level of the participant's motor agility and dynamic balance and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Physical fitness---30-sec sit to stand
30-sec sit to stand (times in 30sec) is assessed lower body strength, needed for numerous tasks such as climbing stairs, walking and getting out of a chair. Also reduces the chance of falling. Number of full stands that can be completed in 30 seconds with arms folded across chest and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Full Information
NCT ID
NCT03339323
First Posted
November 8, 2017
Last Updated
March 12, 2020
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03339323
Brief Title
The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty
Official Title
The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background:
Total knee arthroplasty (TKA) is one of the most common operations in orthopedics. After surgery, the decline of bone mineral density and muscle mass was proved, oral bisphosphonate is commonly used to prevent BMD loss in clinic treatment, however, the loss of muscle mass can only be maintained with exercise intervention. The goals of TKA rehabilitation should be based on control pain, improve ambulation, maximize the range of motion, develop muscle strength, and provide emotional support. We planned to find out a potential adjuvant effective option in muscle mass for the management of post-TKA. Literature suggested that exercise training has been found to have the considerable effect on TKA. However, no suitable exercise prescription was established on the scientific basis. The current study aimed to find out a potential treatment mode.
Study Rationale:
This project will be performed for consecutive three years, the patients with post-TKA patients are managed with the treadmill exercise training in the first year. In the second year, resistance exercise is prescribed. In the third year, eccentric exercise plus resistance training will be arranged in the exercise group. We will analyze the data of the three years and cross-comparative analysis. A prescription of exercise training, a period of 24 weeks each year, 3 times a week, for each 10 minutes warm-up, 40 minutes exercise training, and 10-minute cool down for exercise prescription
Study Objectives:
To investigate the effect of long-term exercise training, eccentric and resistance exercise on muscle mass in patients with total knee arthroplasty. To monitor the performance index included: physiological indices, muscle mass, ambulation and the quality of life index.
Study Design Duration of Treatment: Total of 6-month exercise intervention in each year. The number of Planned Patients: 35 subjects in each control and exercise group in one year, the total of 210 subjects in three years.
Investigational Product: Automated biochemistry analyzer, Biospace Inbody 7.20 Analysis of body composition instrumentation; Dual Energy X-ray Absorptiometer (DEXA), isokinetic muscle strength measurement, VICON to analysis ambulation, functional fitness, the questionnaire including SF-36, KOOS and VAS pain score.
Endpoints: Data collection in pre-surgery, 3 months, 6 months, 9 months and 12 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Arthropathy of Knee Joint
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard rehabilitation procedure
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Aerobic exercise combined with resistance training; Concentric resistance training; Eccentric resistance training
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
TKA patients do the exercise intervention
Primary Outcome Measure Information:
Title
Change from baseline muscle mass
Description
Muscle mass measurement is measured by dual-energy x-ray absorptiometry (DXA). DXA measures the muscle mass of the whole body and the measurement is assessed at pre-operation, three months, six months and nine months after the operation, and twelve-month follow-up.
Time Frame
Baseline; three month ; six month and nine month after operation; twelve-month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline lower extremity muscle strength
Description
Lower extremity muscle strength, including extension and flexion of the hip, knee and ankle were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min. The participants are assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up and received verbal encouragement during the exertion of peak torque.
Time Frame
Baseline; three month ; six month and nine month after operation; twelve-month follow-up
Title
Motion analysis
Description
Gait analysis by VICON three-dimensional, 8-camera motion capture system.The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Time Frame
Baseline; three month ; six month and nine month after operation; twelve-month follow-up
Title
Change from baseline SF-36 questionnaire assessment
Description
SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower score the more disability. The higher the score the less disability. Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score. The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Time Frame
Baseline; three month ; six month and nine month after operation; twelve-month follow-up
Title
Change from baseline KOOS questionnaire assessment
Description
KOOS contains 5 subscales with a total of 42 items: 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation and 5) knee-related quality of life. Each question receives a score from 0 to 4 and the scores are transformed to a 0-100 score (0, extreme symptoms, 100, no symptoms). The User's Guide, is available from www.koos.nu. The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Time Frame
Baseline; three month ; six month and nine month after operation; twelve-month follow-up
Title
Physical fitness---6-minutes' walk test
Description
The 6-minutes' walk test measures the distance an individual is able to walk over a total of 6 minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Time Frame
Baseline; three month , six month and nine month after operation; twelve-month follow-up
Title
Physical fitness---8 feet up and go
Description
The 8 feet up and go test indicates the level of the participant's motor agility and dynamic balance and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Time Frame
Baseline; three month , six month and nine month after operation; twelve-month follow-up
Title
Physical fitness---30-sec sit to stand
Description
30-sec sit to stand (times in 30sec) is assessed lower body strength, needed for numerous tasks such as climbing stairs, walking and getting out of a chair. Also reduces the chance of falling. Number of full stands that can be completed in 30 seconds with arms folded across chest and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Time Frame
Baseline; three month , six month and nine month after operation; twelve-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.
Exclusion Criteria:
The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Wen-Wei HSU, MD
Phone
+886-5-362-1000
Ext
2000
Email
wwh@cgmh.org.tw
Facility Information:
Facility Name
Sports Medicine Center, Chang Gung Memorial Hospital
City
Chiayi City
ZIP/Postal Code
613
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao-Ling Lai, bachelor
Phone
Tel: +886-5-362-1000
Ext
2515
Email
zhaoling0708@yahoo.com.tw
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty
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