- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03722277
Variable Resistance Training in Patients With Osteoarthrosis of the Knee
Variable Resistance Training Versus Conventional Rubber Band Training: Effects on Functional Capacity and Strength in Patients With Osteoarthrosis of the Knee
This is a randomized controlled trial investigating the effect of variable load training in patients with knee osteoarthrosis.
The intervention will consist of resistance training with variable load in knee extension- and flexion. The control group will receive conventional strength training with rubber band.
Outcome measures will be the Knee Osteoarthrosis Outcome Score, functional capacity measured in a sit to stand test, 30m. pace walk and a 9 step stair climb test. Additionally isometric strength in knee flexion- and extension will be measured.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Knee pain and minimum three of the following
- >50 years
- morning stiffness < 30 min
- crepitation
- bone tenderness
- bone osteophytes
- absence of inflammation
Exclusion Criteria:
- Other causes of symptoms to the knee
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Variable load training
The participants will be training two times per week in 10 weeks. Training will consist of variable load training in knee flexion- and extension. Training will be based on symptoms in isometric strength at five different angles of flexion- and extension. |
Based on symptoms/strength measured in an isometric maximum strength test at five different angles of knee flexion- and extension, participants will be training with variable load during both concentric and excentric phase of the dynamic movement.
Initially participants will start at 40% of symptom limited isometric strength, this will increase to 50% during the training period.
|
|
ACTIVE_COMPARATOR: Conventional strength training
The participants will be training two times per week in 10 weeks.
Training will consist of a training programme consisting of strength training with rubber bands for hip and knee.
|
Conventional strength training with rubber bands in knee flexion- and extension, additionally hip abduction- and adduction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self reported knee function
Time Frame: At baseline and 10 weeks follow up
|
Knee Osteoarthrosis Outcome Score (100-0, 100 indicating no symptoms and 0 indicating extreme symptoms)
|
At baseline and 10 weeks follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in functional capacity
Time Frame: At baseline and 10 weeks follow up
|
Sit to stand test
|
At baseline and 10 weeks follow up
|
|
Change in isometric strength
Time Frame: At baseline and 10 weeks follow up
|
Isometric strength in knee flexion- and extension
|
At baseline and 10 weeks follow up
|
|
Change in functional capacity
Time Frame: At baseline and 10 weeks follow up
|
30m pace walk
|
At baseline and 10 weeks follow up
|
|
Change in functional capacity
Time Frame: At baseline and 10 weeks follow up
|
9 step stair climb test
|
At baseline and 10 weeks follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
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
- Variable Load
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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