Trial Outcomes & Findings for Post-Stroke Optimization of Walking Using Explosive Resistance (NCT NCT03826771)
NCT ID: NCT03826771
Last Updated: 2025-04-24
Results Overview
The HAM-D is a clinician-rated scale with scores based on clinical interview and family report. It addresses both somatic and psychological symptoms of depression. Items are rated on either a 5-point scale (0 to 4) or 3-point scale (0 to 2), where higher scores represent increasing severity of depression. The scores of the 17 items are summed to obtain a total score (minimum score: 0, maximum score: 52).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Visit 1 through visit 24 (up to 12 weeks)
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
POWER Training - Depressed
high velocity strength training for depressed individuals
Power training: high-intensity lower extremity resistance training
|
Stretching
Upper and lower body range of motion exercises
Stretching: upper and lower body range of motion exercises
|
POWER Training - Non-Depressed
high velocity strength training for non-depressed individuals
Power training: high-intensity lower extremity resistance training
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
12
|
17
|
|
Overall Study
COMPLETED
|
12
|
9
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Stroke Optimization of Walking Using Explosive Resistance
Baseline characteristics by cohort
| Measure |
POWER Training - Depressed
n=19 Participants
high velocity strength training in depressed individuals
Power training: high-intensity lower extremity resistance training
|
Stretching
n=12 Participants
Upper and lower body range of motion exercises
Stretching: upper and lower body range of motion exercises
|
POWER Training - Non-Depressed
n=17 Participants
high velocity strength training in non-depressed individuals
Power training: high-intensity lower extremity resistance training
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
32 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
16 Participants
n=31 Participants
|
|
Age, Continuous
|
51.37 years
STANDARD_DEVIATION 10.82 • n=39 Participants
|
57.83 years
STANDARD_DEVIATION 12.25 • n=41 Participants
|
62.59 years
STANDARD_DEVIATION 9.8 • n=35 Participants
|
56.96 years
STANDARD_DEVIATION 11.70 • n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
18 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
29 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Visit 1 through visit 24 (up to 12 weeks)The HAM-D is a clinician-rated scale with scores based on clinical interview and family report. It addresses both somatic and psychological symptoms of depression. Items are rated on either a 5-point scale (0 to 4) or 3-point scale (0 to 2), where higher scores represent increasing severity of depression. The scores of the 17 items are summed to obtain a total score (minimum score: 0, maximum score: 52).
Outcome measures
| Measure |
POWER Training - Depressed
n=14 Participants
high velocity strength training in depressed individuals
Power training: high-intensity lower extremity resistance training
|
Stretching
n=9 Participants
Upper and lower body range of motion exercises
Stretching: upper and lower body range of motion exercises
|
POWER Training - Non-Depressed
n=15 Participants
high velocity strength training in non-depressed individuals
Power training: high-intensity lower extremity resistance training
|
|---|---|---|---|
|
Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression
|
5.20 units on a scale
Standard Deviation 4.31
|
2.17 units on a scale
Standard Deviation 4.72
|
0.14 units on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Visit 1 through visit 24 (up to 12 weeks)Subjects will walk on a 14-ft. long gait mat (GaitRite) to measure self-selected and fastest comfortable walking speed and other spatiotemporal parameters of walking. Subjects will be permitted a practice trial, and then be asked to complete three trials at each speed. For all trials, subjects will wear their own shoes and be asked to walk without an assistive device or ankle-foot orthosis.
Outcome measures
| Measure |
POWER Training - Depressed
n=14 Participants
high velocity strength training in depressed individuals
Power training: high-intensity lower extremity resistance training
|
Stretching
n=9 Participants
Upper and lower body range of motion exercises
Stretching: upper and lower body range of motion exercises
|
POWER Training - Non-Depressed
n=15 Participants
high velocity strength training in non-depressed individuals
Power training: high-intensity lower extremity resistance training
|
|---|---|---|---|
|
Change in Self Selected Walking Speed
|
0.08 meters per second
Standard Deviation 0.02
|
0.06 meters per second
Standard Deviation 0.02
|
0.21 meters per second
Standard Deviation 0.06
|
Adverse Events
POWER Training - Depressed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stretching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
POWER Training - Non-Depressed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
POWER Training - Depressed
n=19 participants at risk
high velocity strength training in depressed individuals
Power training: high-intensity lower extremity resistance training
|
Stretching
n=12 participants at risk
Upper and lower body range of motion exercises
Stretching: upper and lower body range of motion exercises
|
POWER Training - Non-Depressed
n=17 participants at risk
high velocity strength training in non-depressed individuals
Power training: high-intensity lower extremity resistance training
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
mild injury (sprain/contusion)
|
10.5%
2/19 • Number of events 2 • throughout the 12 week training intervention
|
0.00%
0/12 • throughout the 12 week training intervention
|
5.9%
1/17 • Number of events 1 • throughout the 12 week training intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place