Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments normal activities and clinical care, concentric focused resistance exercise, eccentric focused resistance exercise
Sponsor University of Florida
Start date November 2010
End date June 2013
Trial size 90 participants
Trial identifier NCT01245283, 614-2009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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)
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.
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)
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.
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.

Primary Outcomes

Measure
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score); Change from Baseline at 4 Months
time frame: Baseline, 4 Months
Medical Outcomes Short Form (SF-36); Change from Baseline at 4 Months
time frame: Baseline, 4 Months
Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 4 Months
time frame: Baseline, 4 Months

Secondary Outcomes

Measure
Six Minute Walk Test; Change from Baseline at 4 Months
time frame: Baseline, 4 Months
Chair Rise Time and Stair Climb Time; Change from Baseline at 4 Months
time frame: Baseline, 4 Months
Habitual Physical Activity; Change from Baseline at 4 Months
time frame: Baseline, 4 Months
Gait Analysis; Change from Baseline at 4 Months
time frame: Baseline, 4 Months
Biomarkers of Cartilage Turnover - Collagen Type II C-telopeptide (CTX-II); Change from Baseline at 4 Months
time frame: Baseline, 4 Months
Biomarkers of Cartilage Turnover - C-propeptide of type II procollagen (CPII); Change from Baseline at 4 Months
time frame: Baseline, 4 Months
Maximal Aerobic Fitness
time frame: Baseline
Changes in Fat Free Mass; Change from Baseline at 4 Months
time frame: Baseline, 4 Months

Eligibility Criteria

Male or female participants from 60 years up to 85 years old.

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

Additional Information

Official title Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
Principal investigator Kevin R Vincent, M.D. Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University of Florida.