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

Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: normal activities and clinical care; Other: Concentric Focused Resistance Exercise; Other: Eccentric Focused Resistance Exercise

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • UF&Shands Orthopaedics and Sports Medicine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 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)	Baseline, 4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Test; Change From Baseline at 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.	Baseline, 4 Months
Chair Rise Time and Stair Climb Time; Change From Baseline at 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.	Baseline, 4 Months
Leg Press Test; Change From Baseline at 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.	Baseline, 4 Months
Leg Extensions Test; Change From Baseline at 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.	Baseline, 4 Months
Leg Curl Test; Change From Baseline at 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.	Baseline, 4 Months
Chest Press; Change From Baseline at 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.	Baseline, 4 Months
Shoulder Press Test; Change From Baseline at 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.	Baseline, 4 Months
Seated Row Test; Change From Baseline at 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.	Baseline, 4 Months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Kevin R Vincent, M.D. Ph.D., University of Florida Department of Orthopaedics and Rehabilitaion

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 19, 2010
• First Posted (Estimate): November 22, 2010

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: osteoarthritis; pain; knee; function; impairment
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 614-2009