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

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ClinicalTrials.gov Identifier: NCT01245283
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : October 8, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Knee Osteoarthritis
Interventions Other: normal activities and clinical care
Other: Concentric Focused Resistance Exercise
Other: Eccentric Focused Resistance Exercise
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description

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

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

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.

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.

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.

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.

Period Title: Overall Study
Started 32 28 30
Completed 18 17 19
Not Completed 14 11 11
Reason Not Completed
Lost to Follow-up             14             11             11
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX) Total
Hide Arm/Group Description

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

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

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 32 28 30 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 28 participants 30 participants 90 participants
68.9  (7.1) 69.5  (6.5) 66.8  (5.4) 68.27  (6.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 30 participants 90 participants
Female
22
  68.8%
19
  67.9%
21
  70.0%
62
  68.9%
Male
10
  31.3%
9
  32.1%
9
  30.0%
28
  31.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 28 participants 30 participants 90 participants
32 28 30 90
1.Primary Outcome
Title Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:

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

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

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.

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.

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.

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.

Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
WOMAC total baseline 27.1  (12.6) 33.3  (14.1) 28.9  (11.6)
WOMAC total 4 months 26.7  (20) 23  (13.7) 19.9  (14.0)
WOMAC Knee pain baseline 4.3  (2.2) 5.4  (2.9) 6.1  (2.7)
WOMAC Knee pain 4 months 4.1  (3.0) 3.9  (3.3) 3.4  (3.0)
WOMAC Knee stiffness baseline 3.8  (1.8) 4.1  (1.5) 3.5  (1.6)
WOMAC Knee stiffness 4 months 3.7  (2.1) 3.1  (1.6) 3.1  (2.2)
WOMAC Knee physical function baseline 18.9  (9.8) 24.4  (11.1) 19.2  (8.4)
WOMAC Knee physical function 4 months 18.7  (16.3) 15.9  (9.6) 13.3  (9.6)
2.Secondary Outcome
Title Six Minute Walk Test; Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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.
Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: feet
Six Minute Walk Baseline 1556  (342) 3600  (1181) 4652  (1520)
Six Minute Walk 4 months 1640  (370) 3496  (1308) 4643  (1127)
3.Secondary Outcome
Title Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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.
Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: Seconds
Chair Rise Time baseline 1.5  (1.1) 1.2  (0.7) 1.2  (0.6)
Chair Rise Time 4 months 0.7  (0.3) 0.8  (0.3) 1.6  (3.8)
Stair Climb Time baseline 6.2  (2.9) 5.3  (3.1) 4.3  (1.5)
Stair Climb Time 4 months 7.3  (3.5) 5.3  (1.8) 5.1  (1.8)
4.Secondary Outcome
Title Leg Press Test; Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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.
Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: foot x pounds
Leg Press Baseline 319  (116) 374  (99) 327  (116)
Leg Press 4 months 399  (109) 357  (115) 412  (97)
5.Secondary Outcome
Title Leg Extensions Test; Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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.
Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: foot x pounds
Leg Extention Baseline 147  (58) 186  (97) 174  (104)
Leg Extention 4 months 181  (87) 167  (91) 191  (89)
6.Secondary Outcome
Title Leg Curl Test; Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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.
Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: foot x pounds
Leg Curl Baseline 154  (42) 168  (57) 155  (63)
Leg Curl 4 months 182  (63) 166  (53) 175  (49)
7.Secondary Outcome
Title Chest Press; Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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.
Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: foot x pounds
Chest Press Baseline 170  (70) 184  (137) 167  (103)
Chest Press 4 months 199  (117) 170  (117) 174  (123)
8.Secondary Outcome
Title Shoulder Press Test; Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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.
Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: foot x pounds
Shoulder Press Baseline 158  (56) 158  (96) 152  (86)
Shoulder Press 4 months 190  (92) 153  (87) 147  (90)
9.Secondary Outcome
Title Seated Row Test; Change From Baseline at 4 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description:
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
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.
Overall Number of Participants Analyzed 32 28 30
Mean (Standard Deviation)
Unit of Measure: foot x pounds
Seated Row Baseline 195  (64) 194  (88) 175  (79)
Seated Row 4 months 215  (99) 219  (88) 193  (107)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Hide Arm/Group Description

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

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

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.

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.

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.

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.

All-Cause Mortality
Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/28 (0.00%)      1/30 (3.33%)    
Musculoskeletal and connective tissue disorders       
Broken hip  1  0/32 (0.00%)  0 0/28 (0.00%)  0 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Wait-list Non-exercise Control (CON) Concentric Focused RX (CRX) Eccentric Focused RX (ERX)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/32 (6.25%)      2/28 (7.14%)      1/30 (3.33%)    
Musculoskeletal and connective tissue disorders       
Subject inability to complete the maximum exercise test  1 [1]  2/32 (6.25%)  2/28 (7.14%)  1/30 (3.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Not related to study
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kevin R. Vincent, M.D. Ph.D.
Organization: UF&Shands Orthopaedics and Sports Medicine Institute
Phone: 352-273-7458
EMail: vincekr@ortho.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01245283    
Other Study ID Numbers: 614-2009
First Submitted: November 5, 2010
First Posted: November 22, 2010
Results First Submitted: July 2, 2014
Results First Posted: October 8, 2014
Last Update Posted: December 5, 2014