Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01245283
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : October 8, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE November 5, 2010
First Posted Date  ICMJE November 22, 2010
Results First Submitted Date  ICMJE July 2, 2014
Results First Posted Date  ICMJE October 8, 2014
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status. Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible). 0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) [ Time Frame: Baseline, 4 Months ]
    The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status.
  • Medical Outcomes Short Form (SF-36) [ Time Frame: Baseline, 4 Months ]
    A validated, internationally recognized standard instrument for assessing perceived Quality of Life (QOL) will be used to assess overall QOL. Subjects will complete the assessment at the time intervals indicated to document any change in their perception of their QOL.
  • Tampa Scale of Kinesiophobia (TSK) [ Time Frame: Baseline, 4 Months ]
    We have shown that this measurement predicts self-reported disability in patients with chronic musculoskeletal pain. Subjects will complete the TSK at the time intervals indicated to document any change in their pereception of their disability.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
  • Six Minute Walk Test; Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
    Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change. 6 minute walk test is a baseline and 4 month post intervention measurement. It is used to measure distance covered while walking during 6 minutes.
  • Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
    Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.
  • Leg Press Test; Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
    Each participant will do a one repetition maximum. Participants will perform a leg press. The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.
  • Leg Extensions Test; Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
    Each participant perform a one repetition maximum . Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs. The exercise is done using a machine called the Leg Extension Machine. This resistence is measured in pounds.
  • Leg Curl Test; Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
    Each participant will perform a one repetition maximum. Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles. The exercise involves flexing the lower leg against resistance towards the buttocks. This resistence is measured in pounds.
  • Chest Press; Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
    Each participant will perform a one repetition maximum. Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position. This resistence is measured in pounds.
  • Shoulder Press Test; Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
    Each participant will perform a one repetition maximum. Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead. This resistence is measured in pounds.
  • Seated Row Test; Change From Baseline at 4 Months [ Time Frame: Baseline, 4 Months ]
    Each participant will perform a one repetition maximum. Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position. This resistence is measured in pounds.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
  • Six Minute Walk Test [ Time Frame: Baseline, 4 Months ]
    Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change.
  • Chair Rise Time and Stair Climb Time [ Time Frame: Baseline, 4 Months ]
    Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any chage in their functional abilities.
  • Habitual Physical Activity [ Time Frame: Baseline, 4 Months ]
    To determine whether the patient increased habitual physical activity within the community during the study period, a 7-day pedometer test will be performed. Subjects will complete the 7-day pedometer test at the time intervals indicated to document any change in their habitual physical activity.
  • Gait Analysis [ Time Frame: Baseline, 4 Months ]
    The gait analysis will be a simple test that involves walking on a 26' long portable gait mat. Subjects will complete the analysis at the time intervals indicated to document any change in their gait.
  • Biomarkers of Cartilage Turnover - Collagen Type II C-telopeptide (CTX-II) [ Time Frame: Baseline, 4 Months ]
    CTX-II is a major structural component of cartilage. The measurement of CTXII in urine is a marker of cartilage degradation and has been shown to be sensitive to OA severity and radiographic evidence of disease progression. Analysis will be performed at the time intervals indicated to document any change in levels of the biomarker.
  • Biomarkers of Cartilage Turnover - C-propeptide of type II procollagen (CPII) [ Time Frame: Baseline, 4 Months ]
    CPII is a marker of cartilage synthesis and has been shown to be sensitive to radiographic OA severity as well as disease progression. Analysis will be completed at the time intervals indicated to document any change in the levels of the biomarker.
  • Maximal Aerobic Fitness [ Time Frame: Baseline ]
    Tthe participant's maximal aerobic fitness, or oxygen consumption (VO2max) will be determined using a walking symptom-limited graded exercise test at baseline to ensure the participant is safe to engage in a resistance exercise program.
  • Changes in Fat Free Mass [ Time Frame: Baseline, 4 Months ]
    Improvements in fat free mass may be related to improvements in function and knee pain. Analysis will be completed at the time intervals indicated to document any change.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
Official Title  ICMJE Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
Brief Summary The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Other: normal activities and clinical care
    Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines
  • Other: Concentric Focused Resistance Exercise
    Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
  • Other: Eccentric Focused Resistance Exercise
    Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Study Arms  ICMJE
  • Active Comparator: Wait-list Non-exercise Control (CON)
    Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
    Intervention: Other: normal activities and clinical care
  • Active Comparator: Concentric Focused RX (CRX)
    Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
    Intervention: Other: Concentric Focused Resistance Exercise
  • Active Comparator: Eccentric Focused RX (ERX)
    The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while "assistance" is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
    Intervention: Other: Eccentric Focused Resistance Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2010)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis (OA) of the knee for >6 months
  • moderate to severe pain immediately following a 50-foot walk
  • knee pain primarily due to tibiofemoral OA and not from patellofemoral OA
  • bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee
  • willing and able to participate in regular exercise for four months
  • free from musculoskeletal limitations that would preclude resistance exercise participation
  • free of abnormal cardiovascular responses during the screening graded maximal walk test

Exclusion Criteria:

  • unable to walk
  • regular resistance exercise training (>3X week) within the past 6 months
  • specific low back pain or acute back injury
  • spinal stenosis that precludes walking one block due to neurogenic claudication
  • any major injury to either knee within the prior 12 months
  • any surgery to either knee within the last 12 months
  • lumbar radiculopathy
  • vascular claudication
  • significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee
  • have had corticosteroid or viscosupplement injections within three months of study participation
  • have added new over the counter or prescription pain medication within two months of study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01245283
Other Study ID Numbers  ICMJE 614-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kevin R Vincent, M.D. Ph.D. University of Florida Department of Orthopaedics and Rehabilitaion
PRS Account University of Florida
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP