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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
University College South Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistance Training

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 18, 2018
    Last Updated
    October 25, 2018
    Sponsor
    University College South Denmark
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    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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