Trial Outcomes & Findings for Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover (NCT NCT01245283)
NCT ID: NCT01245283
Last Updated: 2014-12-05
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Baseline, 4 Months
Results posted on
2014-12-05
Participant Flow
Participant milestones
| Measure |
Wait-list Non-exercise Control (CON)
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
|
Concentric Focused RX (CRX)
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.
|
Eccentric Focused RX (ERX)
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 Study
STARTED
|
32
|
28
|
30
|
|
Overall Study
COMPLETED
|
18
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
11
|
Reasons for withdrawal
| Measure |
Wait-list Non-exercise Control (CON)
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
|
Concentric Focused RX (CRX)
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.
|
Eccentric Focused RX (ERX)
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 Study
Lost to Follow-up
|
14
|
11
|
11
|
Baseline Characteristics
Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
Baseline characteristics by cohort
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
68.27 years
STANDARD_DEVIATION 6.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
28 participants
n=7 Participants
|
30 participants
n=5 Participants
|
90 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 MonthsThe 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)
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
WOMAC total baseline
|
27.1 units on a scale
Standard Deviation 12.6
|
33.3 units on a scale
Standard Deviation 14.1
|
28.9 units on a scale
Standard Deviation 11.6
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
WOMAC total 4 months
|
26.7 units on a scale
Standard Deviation 20
|
23 units on a scale
Standard Deviation 13.7
|
19.9 units on a scale
Standard Deviation 14.0
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
WOMAC Knee pain baseline
|
4.3 units on a scale
Standard Deviation 2.2
|
5.4 units on a scale
Standard Deviation 2.9
|
6.1 units on a scale
Standard Deviation 2.7
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
WOMAC Knee pain 4 months
|
4.1 units on a scale
Standard Deviation 3.0
|
3.9 units on a scale
Standard Deviation 3.3
|
3.4 units on a scale
Standard Deviation 3.0
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
WOMAC Knee stiffness baseline
|
3.8 units on a scale
Standard Deviation 1.8
|
4.1 units on a scale
Standard Deviation 1.5
|
3.5 units on a scale
Standard Deviation 1.6
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
WOMAC Knee stiffness 4 months
|
3.7 units on a scale
Standard Deviation 2.1
|
3.1 units on a scale
Standard Deviation 1.6
|
3.1 units on a scale
Standard Deviation 2.2
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
WOMAC Knee physical function baseline
|
18.9 units on a scale
Standard Deviation 9.8
|
24.4 units on a scale
Standard Deviation 11.1
|
19.2 units on a scale
Standard Deviation 8.4
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
WOMAC Knee physical function 4 months
|
18.7 units on a scale
Standard Deviation 16.3
|
15.9 units on a scale
Standard Deviation 9.6
|
13.3 units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsEach 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.
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Six Minute Walk Test; Change From Baseline at 4 Months
Six Minute Walk Baseline
|
1556 feet
Standard Deviation 342
|
3600 feet
Standard Deviation 1181
|
4652 feet
Standard Deviation 1520
|
|
Six Minute Walk Test; Change From Baseline at 4 Months
Six Minute Walk 4 months
|
1640 feet
Standard Deviation 370
|
3496 feet
Standard Deviation 1308
|
4643 feet
Standard Deviation 1127
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsFunctional 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.
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Chair Rise Time baseline
|
1.5 Seconds
Standard Deviation 1.1
|
1.2 Seconds
Standard Deviation 0.7
|
1.2 Seconds
Standard Deviation 0.6
|
|
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Chair Rise Time 4 months
|
0.7 Seconds
Standard Deviation 0.3
|
0.8 Seconds
Standard Deviation 0.3
|
1.6 Seconds
Standard Deviation 3.8
|
|
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Stair Climb Time baseline
|
6.2 Seconds
Standard Deviation 2.9
|
5.3 Seconds
Standard Deviation 3.1
|
4.3 Seconds
Standard Deviation 1.5
|
|
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Stair Climb Time 4 months
|
7.3 Seconds
Standard Deviation 3.5
|
5.3 Seconds
Standard Deviation 1.8
|
5.1 Seconds
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsEach 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.
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Leg Press Test; Change From Baseline at 4 Months
Leg Press Baseline
|
319 foot x pounds
Standard Deviation 116
|
374 foot x pounds
Standard Deviation 99
|
327 foot x pounds
Standard Deviation 116
|
|
Leg Press Test; Change From Baseline at 4 Months
Leg Press 4 months
|
399 foot x pounds
Standard Deviation 109
|
357 foot x pounds
Standard Deviation 115
|
412 foot x pounds
Standard Deviation 97
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsEach 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.
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Leg Extensions Test; Change From Baseline at 4 Months
Leg Extention Baseline
|
147 foot x pounds
Standard Deviation 58
|
186 foot x pounds
Standard Deviation 97
|
174 foot x pounds
Standard Deviation 104
|
|
Leg Extensions Test; Change From Baseline at 4 Months
Leg Extention 4 months
|
181 foot x pounds
Standard Deviation 87
|
167 foot x pounds
Standard Deviation 91
|
191 foot x pounds
Standard Deviation 89
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsEach 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.
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Leg Curl Test; Change From Baseline at 4 Months
Leg Curl Baseline
|
154 foot x pounds
Standard Deviation 42
|
168 foot x pounds
Standard Deviation 57
|
155 foot x pounds
Standard Deviation 63
|
|
Leg Curl Test; Change From Baseline at 4 Months
Leg Curl 4 months
|
182 foot x pounds
Standard Deviation 63
|
166 foot x pounds
Standard Deviation 53
|
175 foot x pounds
Standard Deviation 49
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsEach 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.
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Chest Press; Change From Baseline at 4 Months
Chest Press Baseline
|
170 foot x pounds
Standard Deviation 70
|
184 foot x pounds
Standard Deviation 137
|
167 foot x pounds
Standard Deviation 103
|
|
Chest Press; Change From Baseline at 4 Months
Chest Press 4 months
|
199 foot x pounds
Standard Deviation 117
|
170 foot x pounds
Standard Deviation 117
|
174 foot x pounds
Standard Deviation 123
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsEach 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.
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Shoulder Press Test; Change From Baseline at 4 Months
Shoulder Press Baseline
|
158 foot x pounds
Standard Deviation 56
|
158 foot x pounds
Standard Deviation 96
|
152 foot x pounds
Standard Deviation 86
|
|
Shoulder Press Test; Change From Baseline at 4 Months
Shoulder Press 4 months
|
190 foot x pounds
Standard Deviation 92
|
153 foot x pounds
Standard Deviation 87
|
147 foot x pounds
Standard Deviation 90
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsEach 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.
Outcome measures
| Measure |
Wait-list Non-exercise Control (CON)
n=32 Participants
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
|
Concentric Focused RX (CRX)
n=28 Participants
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.
|
Eccentric Focused RX (ERX)
n=30 Participants
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.
|
|---|---|---|---|
|
Seated Row Test; Change From Baseline at 4 Months
Seated Row Baseline
|
195 foot x pounds
Standard Deviation 64
|
194 foot x pounds
Standard Deviation 88
|
175 foot x pounds
Standard Deviation 79
|
|
Seated Row Test; Change From Baseline at 4 Months
Seated Row 4 months
|
215 foot x pounds
Standard Deviation 99
|
219 foot x pounds
Standard Deviation 88
|
193 foot x pounds
Standard Deviation 107
|
Adverse Events
Wait-list Non-exercise Control (CON)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Concentric Focused RX (CRX)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Eccentric Focused RX (ERX)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wait-list Non-exercise Control (CON)
n=32 participants at risk
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
|
Concentric Focused RX (CRX)
n=28 participants at risk
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.
|
Eccentric Focused RX (ERX)
n=30 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Broken hip
|
0.00%
0/32
|
0.00%
0/28
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Wait-list Non-exercise Control (CON)
n=32 participants at risk
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
|
Concentric Focused RX (CRX)
n=28 participants at risk
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.
|
Eccentric Focused RX (ERX)
n=30 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Subject inability to complete the maximum exercise test
|
6.2%
2/32
|
7.1%
2/28
|
3.3%
1/30
|
Additional Information
Kevin R. Vincent, M.D. Ph.D.
UF&Shands Orthopaedics and Sports Medicine Institute
Phone: 352-273-7458
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place