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

NCT01245283 | Completed Results

• 1 other identifier: 614-2009
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee; osteoarthritis; pain; function; impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Six Minute Walk Test; Change From Baseline at 4 Months

  Baseline, 4 Months

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

  Baseline, 4 Months

• Leg Press Test; Change From Baseline at 4 Months

  Baseline, 4 Months

• Leg Extensions Test; Change From Baseline at 4 Months

  Baseline, 4 Months

• Leg Curl Test; Change From Baseline at 4 Months

  Baseline, 4 Months

Study Arms (3)

Wait-list Non-exercise Control (CON)

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.

Other: normal activities and clinical care

Concentric Focused RX (CRX)

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.

Other: Concentric Focused Resistance Exercise

Eccentric Focused RX (ERX)

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.

Other: Eccentric Focused Resistance Exercise

Interventions

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

Wait-list Non-exercise Control (CON)

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.

Concentric Focused RX (CRX)

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.

Eccentric Focused RX (ERX)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kevin R. Vincent, M.D. Ph.D.
• Organization: UF&Shands Orthopaedics and Sports Medicine Institute

vincekr@ortho.ufl.edu

352-273-7458

Study Officials

• Kevin R Vincent, M.D. Ph.D.

  University of Florida Department of Orthopaedics and Rehabilitaion

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 22, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 5, 2014
• Results First Posted: October 8, 2014

Record last verified: 2014-11

Locations

US (1)