Trial Outcomes & Findings for Exercise and Brain Stimulation for Post-stroke Depression (NCT NCT03056287)
NCT ID: NCT03056287
Last Updated: 2025-05-14
Results Overview
The Hamilton Rating Scale for Depression is a clinician-administered depression assessment scale containing 17 items pertaining to symptoms of depression experienced over the past week. A total score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a total score of 20 or higher indicates at least moderate severity depression. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
assessed at baseline and weekly throughout the 8 week intervention. Change from baseline to week 8 reported as primary outcome
Results posted on
2025-05-14
Participant Flow
Participant milestones
| Measure |
Aerobic Exercise
Treadmill aerobic exercise
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
|
rTMS
repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
AET+rTMS
Combined aerobic exercise and rTMS
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
Sham
Sham rTMS
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
4
|
5
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Aerobic Exercise
Treadmill aerobic exercise
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
|
rTMS
repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
AET+rTMS
Combined aerobic exercise and rTMS
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
Sham
Sham rTMS
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
move out of area
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Exercise and Brain Stimulation for Post-stroke Depression
Baseline characteristics by cohort
| Measure |
Aerobic Exercise
n=4 Participants
Treadmill aerobic exercise
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
|
rTMS
n=6 Participants
repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
AET+rTMS
n=6 Participants
Combined aerobic exercise and rTMS
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
Sham
n=7 Participants
Sham rTMS
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
6 participants
n=4 Participants
|
6 participants
n=27 Participants
|
7 participants
n=483 Participants
|
23 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: assessed at baseline and weekly throughout the 8 week intervention. Change from baseline to week 8 reported as primary outcomeThe Hamilton Rating Scale for Depression is a clinician-administered depression assessment scale containing 17 items pertaining to symptoms of depression experienced over the past week. A total score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a total score of 20 or higher indicates at least moderate severity depression. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
Outcome measures
| Measure |
Aerobic Exercise
n=4 Participants
Treadmill aerobic exercise
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
|
rTMS
n=6 Participants
repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
AET+rTMS
n=6 Participants
Combined aerobic exercise and rTMS
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
Sham
n=7 Participants
Sham rTMS
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
|---|---|---|---|---|
|
Change From Baseline to Post Training in Hamilton Rating Scale for Depression
|
-2.75 units on a scale
Standard Deviation 4.5
|
-7.5 units on a scale
Standard Deviation 5.46
|
-7.83 units on a scale
Standard Deviation 4.49
|
-2.29 units on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: assessed at baseline as well as weekly throughout the 8 week intervention. Change from baseline to week 8 reported as outcomeOutcome measures
| Measure |
Aerobic Exercise
n=4 Participants
Treadmill aerobic exercise
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
|
rTMS
n=6 Participants
repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
AET+rTMS
n=6 Participants
Combined aerobic exercise and rTMS
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
Sham
n=7 Participants
Sham rTMS
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
|---|---|---|---|---|
|
Change From Baseline to Week 8 in Self-selected Walking Speed
|
8.2 centimeters per second
Standard Deviation 9.52
|
7.7 centimeters per second
Standard Deviation 15.43
|
30.65 centimeters per second
Standard Deviation 20.24
|
2.19 centimeters per second
Standard Deviation 15.04
|
Adverse Events
Aerobic Exercise
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AET+rTMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aerobic Exercise
n=4 participants at risk
Treadmill aerobic exercise
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
|
rTMS
n=6 participants at risk
repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
AET+rTMS
n=6 participants at risk
Combined aerobic exercise and rTMS
Aerobic exercise: treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
Sham
n=7 participants at risk
Sham rTMS
Repetitive transcranial magnetic stimulation: Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
fall
|
25.0%
1/4 • Number of events 1 • Throughout the 8 week intervention as well as during an 8 week follow-up period. Collected over a total of weeks
|
0.00%
0/6 • Throughout the 8 week intervention as well as during an 8 week follow-up period. Collected over a total of weeks
|
16.7%
1/6 • Number of events 1 • Throughout the 8 week intervention as well as during an 8 week follow-up period. Collected over a total of weeks
|
0.00%
0/7 • Throughout the 8 week intervention as well as during an 8 week follow-up period. Collected over a total of weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place