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Completed

NCT Number: NCT01245283

Resistance Exercise and 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal activities and clinical care

Other

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

Other

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

Other

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

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months

    Time frame: Baseline, 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)

Secondary outcomes

  1. Six Minute Walk Test; Change From Baseline at 4 Months

    Time frame: Baseline, 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.

  2. Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months

    Time frame: Baseline, 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.

  3. Leg Press Test; Change From Baseline at 4 Months

    Time frame: Baseline, 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.

  4. Leg Extensions Test; Change From Baseline at 4 Months

    Time frame: Baseline, 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.

  5. Leg Curl Test; Change From Baseline at 4 Months

    Time frame: Baseline, 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.

  6. Chest Press; Change From Baseline at 4 Months

    Time frame: Baseline, 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.

  7. Shoulder Press Test; Change From Baseline at 4 Months

    Time frame: Baseline, 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.

  8. Seated Row Test; Change From Baseline at 4 Months

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2010
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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