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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245283
• Other study ID #: 614-2009
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: November 19, 2014
• Start date: November 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
United States	UF&Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No