Clinical trial NCT01245283: Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
Official title: Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee
osteoarthritis
pain
function
impairment
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-11-22
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
Secondary outcomes:
measure: Six Minute Walk Test; Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
measure: Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
measure: Leg Press Test; Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
measure: Leg Extensions Test; Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
measure: Leg Curl Test; Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
measure: Chest Press; Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
measure: Shoulder Press Test; Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
measure: Seated Row Test; Change From Baseline at 4 Months
timeFrame: Baseline, 4 Months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida Department of Orthopaedics and Rehabilitaion
name: Kevin R Vincent, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: