Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring osteoarthrosis, unicompartmental knee replacement, knee, resistance training, Muscle power, gait analysis, gait, physiotherapy, Gyro sensor
Eligibility Criteria
Inclusion Criteria:
- medial osteoarthrosis in knee assigned to unicompartmental knee replacement
- 18+ years.
Exclusion Criteria:
- rheumatoid arthritis
- neuro muscular conditions
- alcohol or drug abuse
- cognitive problems
- patients not fluid in the Danish language
- walking disability caused by other than in condition in question
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
resistance training
Arm Description
Outcomes
Primary Outcome Measures
Muscle power test (by a power rig)
Secondary Outcome Measures
Gait quality
Instrumentet gait analysis using a combined gyro-sensor and accelerometer - inertia measurement unit(IMU).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01345825
Brief Title
Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement
Official Title
A Randomized Controlled Trial: The Effectiveness of 8-weeks Progressive Strength Training to Patients With Unicompartmental Knee Replacement, Initiated Within the First Postoperative Week
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose and Study hypotheses:
The purpose of the study is to investigate the effect of progressive resistance training in the early postoperative phase on patients who has had unicompartmental knee replacement. The hypotheses are that this group compared to a control group will achieve greater muscle strength and functional ability in terms of gait and working capacity.
Study design:
The subjects will be randomized into two groups; intervention and control. Intervention group: strength training two times a week supervised by a physiotherapist.
Control group: Training at home, following extradited guidelines.
Endpoint:
Primary endpoint is two months postoperative. The following test will be used: muscle power test (by a Power Rig), instrumented gait analysis using a combined accelerometer and gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step test.
Furthermore, the questionnaire KOOS will be used for monitoring every 2 weeks.
Sample size:
The power calculation is based on an expected improvement in muscle power by 25%. The risk of a type 1 error is set to 5 %, and the power is set to 80%. The calculations showed that 24 patients are needed in both groups, but 30 patient will be included in both groups to account for dropouts.
Perspectives:
This study is, to our knowledge, the first study to investigate the effect of strength training after unicompartmental knee replacement. Moreover it has , to our knowledge not been. At the moment no guidelines for rehabilitation exist, and research showed that this group of patients has a decreased function in their daily living compared with the background population. If, as expected, cases have an overall increased function compared to controls, this study can provide a basis for future rehabilitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
osteoarthrosis, unicompartmental knee replacement, knee, resistance training, Muscle power, gait analysis, gait, physiotherapy, Gyro sensor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
resistance training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
Week 1: 2 sets x 12 repetitions at 12 RM Week 2: 3 sets of 12 repetitions with 12 RM Week 3: 3 sets of 10 repetitions with 10 RM Week 4-5: 3 sets of 10 repetitions with 10 RM Week 6: 3 sets of 8 repetitions with 8 RM Week 7: 4 sets of 8 repetitions with 8 RM Week 8: 4 sets of 8 repetitions with 8 RM
Primary Outcome Measure Information:
Title
Muscle power test (by a power rig)
Time Frame
prior to operation (baseline), 9 weeks post operativ and 1 year post operative
Secondary Outcome Measure Information:
Title
Gait quality
Description
Instrumentet gait analysis using a combined gyro-sensor and accelerometer - inertia measurement unit(IMU).
Time Frame
prior to operation (baseline), 9 weeks post operativ and 1 year post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
medial osteoarthrosis in knee assigned to unicompartmental knee replacement
18+ years.
Exclusion Criteria:
rheumatoid arthritis
neuro muscular conditions
alcohol or drug abuse
cognitive problems
patients not fluid in the Danish language
walking disability caused by other than in condition in question
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Søballe
Organizational Affiliation
Orthopaedic Surgery Research Unit, Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement
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