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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01245283
First received: November 5, 2010
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Other: normal activities and clinical care
Other: Concentric Focused Resistance Exercise
Other: Eccentric Focused Resistance Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score); Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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); Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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); Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Six Minute Walk Test; Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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; Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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; Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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; Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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); Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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); Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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; Change from Baseline at 4 Months [ Time Frame: Baseline, 4 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: November 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245283

Locations
United States, Florida
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Kevin R Vincent, M.D. Ph.D. University of Florida Department of Orthopaedics and Rehabilitaion
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01245283     History of Changes
Other Study ID Numbers: 614-2009
Study First Received: November 5, 2010
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
knee
osteoarthritis
pain
function
impairment

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014