Trial Outcomes & Findings for Power Training Combined With Interval Treadmill Training (NCT NCT03625570)
NCT ID: NCT03625570
Last Updated: 2024-12-13
Results Overview
Calculated from the 10 meter walk test in meters/second at self-selected speed and then normalized by stature to yield non-dimensional units. Higher values represent faster gait speeds.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline and immediate post training (8-10 weeks post baseline)
Results posted on
2024-12-13
Participant Flow
Participants were enrolled at two sites (academic medical center and a children's hospital). Participants were recruited from the surrounding community and regional tertiary pediatric care centers.
Of the 44 enrolled participants, 43 were randomized. 1 participant was excluded prior to randomization due to the inability to cooperate and complete baseline assessments.
Participant milestones
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Traditional Treadmill Training)
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Primary Endpoint - Immediate Post
STARTED
|
23
|
20
|
|
Primary Endpoint - Immediate Post
COMPLETED
|
20
|
18
|
|
Primary Endpoint - Immediate Post
NOT COMPLETED
|
3
|
2
|
|
Secondary Endpoint - 2 Months Post
STARTED
|
20
|
18
|
|
Secondary Endpoint - 2 Months Post
COMPLETED
|
18
|
17
|
|
Secondary Endpoint - 2 Months Post
NOT COMPLETED
|
2
|
1
|
|
Secondary Endpoint - 6 Months Post
STARTED
|
18
|
17
|
|
Secondary Endpoint - 6 Months Post
COMPLETED
|
18
|
16
|
|
Secondary Endpoint - 6 Months Post
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Traditional Treadmill Training)
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Primary Endpoint - Immediate Post
Withdrawal by Subject
|
2
|
1
|
|
Primary Endpoint - Immediate Post
PI decision; unable to perform exercises
|
1
|
0
|
|
Primary Endpoint - Immediate Post
Withdrawn; COVID-19 shut down
|
0
|
1
|
Baseline Characteristics
Power Training Combined With Interval Treadmill Training
Baseline characteristics by cohort
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=23 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=20 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.07 years
STANDARD_DEVIATION 2.18 • n=99 Participants
|
13.77 years
STANDARD_DEVIATION 2.55 • n=107 Participants
|
13.39 years
STANDARD_DEVIATION 2.36 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
20 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
GMFCS Level
GMFCS Level I
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
GMFCS Level
GMFCS Level II
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
GMFCS Level
GMFCS Level III
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Body mass
|
44.43 kilograms (kg)
STANDARD_DEVIATION 12.22 • n=99 Participants
|
48.40 kilograms (kg)
STANDARD_DEVIATION 19.86 • n=107 Participants
|
46.28 kilograms (kg)
STANDARD_DEVIATION 16.15 • n=206 Participants
|
|
Height
|
1.50 meters
STANDARD_DEVIATION 0.12 • n=99 Participants
|
1.53 meters
STANDARD_DEVIATION 0.15 • n=107 Participants
|
1.516 meters
STANDARD_DEVIATION 0.14 • n=206 Participants
|
|
Enrollment Site
LSUHSC
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Enrollment Site
SCRI
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: The a priori analytic approach included all participants in the primary analysis with the first (baseline) and second assessments. Least squares (LS) means adjusted for baseline and 3 covariates (Age group; Site; GMFCS level)
Calculated from the 10 meter walk test in meters/second at self-selected speed and then normalized by stature to yield non-dimensional units. Higher values represent faster gait speeds.
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=20 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Self-selected Gait Speed (Normalized)
|
-0.0010 dimensionless
Standard Error 0.0096
|
0.0163 dimensionless
Standard Error 0.0100
|
PRIMARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: The a priori analytic approach included all participants in the primary analysis with the first (baseline) and second assessments. LS Means adjusted for baseline and 3 covariates (Age group; Site; GMFCS level)
Calculated from the 10 meter walk test in meters/second at fast walking speed and then normalized by stature to yield non-dimensional units. Higher values equal faster gait speeds.
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=20 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Fast Gait Speed (Normalized)
|
0.0204 dimensionless
Standard Error 0.0074
|
0.0093 dimensionless
Standard Error 0.0080
|
PRIMARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: The a priori analytic approach included all participants in the primary analysis with the first (baseline) and second assessments. LS Means adjusted for 3 covariates (Age group; Site; GMFCS level)
Lower extremity peak power produced during a power leg press test averaged over 5 trials; product of force x velocity; adjusted for sled angle and body mass
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=20 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Peak Power
|
71.21 watts
Standard Error 18.71
|
19.19 watts
Standard Error 19.83
|
PRIMARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: The a priori analytic approach included all participants in the primary analysis with the first (baseline) and second assessments. LS Means adjusted for 3 covariates (Age group; Site; GMFCS level)
Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=20 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Average Strides Per Day
|
-95.84 strides/day
Standard Error 284.85
|
-16.03 strides/day
Standard Error 318.79
|
SECONDARY outcome
Timeframe: Baseline and 2 months post training (16 weeks post baseline)Population: LS Means adjusted for baseline and 3 covariates (Age group; Site; GMFCS level)
Calculated from the 10 meter walk test in meters/second at self-selected speed and then normalized by stature to yield non-dimensional units. Higher values equal faster speeds.
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=18 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=17 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Self-selected Gait Speed (Normalized)
|
0.0156 dimensionless
Standard Error 0.0092
|
0.0144 dimensionless
Standard Error 0.0092
|
SECONDARY outcome
Timeframe: Baseline and 2 months post training (16 weeks post baseline)Population: LS Means adjusted for baseline and 3 covariates (Age group; Site; GMFCS level)
Calculated from the 10 meter walk test in meters/second at fast walking speed and then normalized by stature to yield non-dimensional units. Higher values equal faster speeds.
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=18 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=17 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Fast Gait Speed (Normalized)
|
0.0528 dimensionless
Standard Error 0.0125
|
0.0226 dimensionless
Standard Error 0.0127
|
SECONDARY outcome
Timeframe: Baseline and 2 months post training (16 weeks post baseline)Population: LS Means adjusted for 3 covariates (Age group; Site; GMFCS level)
Lower extremity peak power produced during a power leg press test averaged over 5 trials; product of force x velocity; adjusted for sled angle and body mass
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=18 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=16 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Peak Power
|
57.9248 watts
Standard Error 22.3544
|
1.5342 watts
Standard Error 23.4939
|
SECONDARY outcome
Timeframe: Baseline and 2 months post training (16 weeks post baseline)Population: LS Means adjusted for 3 covariates (Age group; Site; GMFCS level)
Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=18 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=13 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Average Strides Per Day
|
-139.77 strides/day
Standard Error 324.13
|
-299.82 strides/day
Standard Error 373.20
|
SECONDARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: LS Means adjusted for baseline and 3 covariates (Age group; Site; GMFCS level)
Distance covered while walking as fast as possible for 1 minute measured in meters
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=20 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in One Minute Walk Test
|
8.349 meters
Standard Error 2.637
|
7.750 meters
Standard Error 2.764
|
SECONDARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: LS Means adjusted for 3 covariates (Age group; Site; GMFCS level) and side tested (left and right)
Cross-sectional area of rectus femoris taken at 50% distance between anterior superior iliac spine and apex of patella using 2D Bmode Ultrasound imaging in cm\^2; Average of Right and Left Sides
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=17 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Cross-sectional Area
|
0.3390 cm^2
Standard Error 0.0667
|
0.2692 cm^2
Standard Error 0.0684
|
SECONDARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: LS means adjusted for 3 covariates (Age group; Site; GMFCS level) and side tested (left and right)
Isokinetic dynamometer (Biodex System 3/4) according to published standard procedures for isokinetic strength. Calculated for knee extensors at 60 degrees/second in newton-meters
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=20 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Isokinetic Muscle Strength of Knee Extensors
|
3.8778 Nm
Standard Error 3.0255
|
2.1524 Nm
Standard Error 3.1937
|
SECONDARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: LS Means adjusted for 3 covariates (Age group; Site; GMFCS level)
Average strides/day at medium (31 to 60 stride/min) and high (\> 60 stride/min) stride rates as captured by Step Watch accelerometer as worn for a minimum of 4 days
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=19 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=16 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute)
|
0.01313 strides/minute
Standard Error 0.0289
|
-0.06635 strides/minute
Standard Error 0.0323
|
SECONDARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: Least squares (LS) means adjusted for 3 covariates (Age group; Site; GMFCS level)
Patient-Reported Outcomes Measurement Information System (PROMIS); The PROMIS item bank was developed from patient-reported outcome measures that indicate patients' state of well-being and functional abilities. The results of the Physical Function-Mobility domain are reported here as the Change in the T-score from baseline to 8-10wks post baseline. The T-score is a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured so for a positive concept, such as Physical Function-Mobility, a higher T-score or 'change' in the T-score represents higher physical functioning and mobility.
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=20 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System Physical Function-Mobility (PROMIS v2.0 Pediatric Profile 49 - Physical Function-Mobility)
|
2.229 T-score
Standard Error 1.72
|
2.792 T-score
Standard Error 1.83
|
SECONDARY outcome
Timeframe: Baseline and immediate post training (8-10 weeks post baseline)Population: LS Means adjusted for baseline and 3 covariates (Age group; Site; GMFCS level)
1repetition maximum (1RM) testing on a leg press reported in lbs; external load reported after adjusting for the angle of the press
Outcome measures
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=20 Participants
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=18 Participants
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Change in 1RM (Muscle Strength)
|
54.568 lbs
Standard Error 13.031
|
49.961 lbs
Standard Error 14.263
|
Adverse Events
PT³ (Power Training Combined With Interval Treadmill Training)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Traditional Training (Strength Training Combined With Treadmill Training)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=23 participants at risk
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=20 participants at risk
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Surgical and medical procedures
Ventriculoperitoneal (VP) shunt revision (Not Related to the Study)
|
4.3%
1/23 • Number of events 1 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
0.00%
0/20 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
Other adverse events
| Measure |
PT³ (Power Training Combined With Interval Treadmill Training)
n=23 participants at risk
Power Training combined with interval treadmill training
Power training combined with interval treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
Traditional Training (Strength Training Combined With Treadmill Training)
n=20 participants at risk
Strength training combined with traditional treadmill training
Strength training combined with traditional treadmill training: Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
blisters
|
8.7%
2/23 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
15.0%
3/20 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
|
Ear and labyrinth disorders
dizziness
|
4.3%
1/23 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
0.00%
0/20 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
|
Respiratory, thoracic and mediastinal disorders
exercise-induced asthma
|
4.3%
1/23 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
0.00%
0/20 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
|
General disorders
fatigue
|
4.3%
1/23 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
0.00%
0/20 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
|
General disorders
knee or leg pain
|
4.3%
1/23 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
20.0%
4/20 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
|
General disorders
muscle soreness
|
4.3%
1/23 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
5.0%
1/20 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
|
General disorders
muscle spasm
|
0.00%
0/23 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
5.0%
1/20 • From enrollment to 6 months post-intervention (32 weeks post baseline)
|
Additional Information
Dr. Noelle G. Moreau
Louisiana State University Health Sciences Center - New Orleans
Phone: 504-568-4291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place