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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
normal activities and clinical care
Concentric Focused Resistance Exercise
Eccentric Focused Resistance Exercise
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, osteoarthritis, pain, function, impairment

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF&Shands Orthopaedics and Sports Medicine Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Wait-list Non-exercise Control (CON)

Concentric Focused RX (CRX)

Eccentric Focused RX (ERX)

Arm Description

Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 5, 2010
Last Updated
November 19, 2014
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01245283
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, osteoarthritis, pain, function, impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait-list Non-exercise Control (CON)
Arm Type
Active Comparator
Arm Description
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
Arm Title
Concentric Focused RX (CRX)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Eccentric Focused RX (ERX)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
normal activities and clinical care
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Concentric Focused Resistance Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Eccentric Focused Resistance Exercise
Intervention Description
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 Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
Description
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)
Time Frame
Baseline, 4 Months
Secondary Outcome Measure Information:
Title
Six Minute Walk Test; Change From Baseline at 4 Months
Description
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.
Time Frame
Baseline, 4 Months
Title
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Description
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.
Time Frame
Baseline, 4 Months
Title
Leg Press Test; Change From Baseline at 4 Months
Description
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.
Time Frame
Baseline, 4 Months
Title
Leg Extensions Test; Change From Baseline at 4 Months
Description
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.
Time Frame
Baseline, 4 Months
Title
Leg Curl Test; Change From Baseline at 4 Months
Description
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.
Time Frame
Baseline, 4 Months
Title
Chest Press; Change From Baseline at 4 Months
Description
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.
Time Frame
Baseline, 4 Months
Title
Shoulder Press Test; Change From Baseline at 4 Months
Description
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.
Time Frame
Baseline, 4 Months
Title
Seated Row Test; Change From Baseline at 4 Months
Description
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.
Time Frame
Baseline, 4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin R Vincent, M.D. Ph.D.
Organizational Affiliation
University of Florida Department of Orthopaedics and Rehabilitaion
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF&Shands Orthopaedics and Sports Medicine Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States

12. IPD Sharing Statement

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

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