Variable Resistance Training in Patients With Osteoarthrosis of the Knee
Primary Purpose
Resistance Training
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Variable load training
Conventional strength training
Sponsored by
About this trial
This is an interventional treatment trial for Resistance Training
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Variable load training
Conventional strength training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in self reported knee function
Knee Osteoarthrosis Outcome Score (100-0, 100 indicating no symptoms and 0 indicating extreme symptoms)
Secondary Outcome Measures
Change in functional capacity
Sit to stand test
Change in isometric strength
Isometric strength in knee flexion- and extension
Change in functional capacity
30m pace walk
Change in functional capacity
9 step stair climb test
Full Information
NCT ID
NCT03722277
First Posted
October 18, 2018
Last Updated
October 25, 2018
Sponsor
University College South Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03722277
Brief Title
Variable Resistance Training in Patients With Osteoarthrosis of the Knee
Official Title
Variable Resistance Training Versus Conventional Rubber Band Training: Effects on Functional Capacity and Strength in Patients With Osteoarthrosis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College South Denmark
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistance Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Variable load training
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional strength training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Variable load training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional strength training
Intervention Description
Conventional strength training with rubber bands in knee flexion- and extension, additionally hip abduction- and adduction.
Primary Outcome Measure Information:
Title
Change in self reported knee function
Description
Knee Osteoarthrosis Outcome Score (100-0, 100 indicating no symptoms and 0 indicating extreme symptoms)
Time Frame
At baseline and 10 weeks follow up
Secondary Outcome Measure Information:
Title
Change in functional capacity
Description
Sit to stand test
Time Frame
At baseline and 10 weeks follow up
Title
Change in isometric strength
Description
Isometric strength in knee flexion- and extension
Time Frame
At baseline and 10 weeks follow up
Title
Change in functional capacity
Description
30m pace walk
Time Frame
At baseline and 10 weeks follow up
Title
Change in functional capacity
Description
9 step stair climb test
Time Frame
At baseline and 10 weeks follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Variable Resistance Training in Patients With Osteoarthrosis of the Knee
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