Trial Outcomes & Findings for tDCS for Increasing Exercise Adherence in Depressed Individuals (NCT NCT03178903)
NCT ID: NCT03178903
Last Updated: 2023-02-27
Results Overview
Accelerometry-based moderate-to-vigorous physical activity (MVPA)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
8 week assessment
Results posted on
2023-02-27
Participant Flow
Participant milestones
| Measure |
tDCS and Aerobic Exercise
Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
Sham tDCS and Aerobic Exercise
Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
tDCS for Increasing Exercise Adherence in Depressed Individuals
Baseline characteristics by cohort
| Measure |
tDCS and Aerobic Exercise
n=25 Participants
Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
Sham tDCS and Aerobic Exercise
n=26 Participants
Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Depressive Symptoms
|
22.9 units on a scale
STANDARD_DEVIATION 10.0 • n=5 Participants
|
21.8 units on a scale
STANDARD_DEVIATION 11.6 • n=7 Participants
|
22.3 units on a scale
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Minutes of Moderate-to-Vigorous Physical Activity (MVPA)
|
14.9 minutes per day
STANDARD_DEVIATION 11.0 • n=5 Participants
|
20.0 minutes per day
STANDARD_DEVIATION 14.4 • n=7 Participants
|
17.4 minutes per day
STANDARD_DEVIATION 13.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 week assessmentPopulation: The numbers analyzed include only individuals that provided valid wear-time data on the primary outcome measure, using accelerometry. Specifically, only participants that provided 3 days of 8 hours/day valid wear time were included in the analysis of the primary outcome.
Accelerometry-based moderate-to-vigorous physical activity (MVPA)
Outcome measures
| Measure |
tDCS and Aerobic Exercise
n=19 Participants
Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
Sham tDCS and Aerobic Exercise
n=17 Participants
Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
|---|---|---|
|
Physical Activity Levels
|
17.4 minutes per day
Standard Deviation 9.8
|
21.0 minutes per day
Standard Deviation 17.4
|
Adverse Events
tDCS and Aerobic Exercise
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham tDCS and Aerobic Exercise
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
tDCS and Aerobic Exercise
n=25 participants at risk
Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
Sham tDCS and Aerobic Exercise
n=26 participants at risk
Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Inpatient Hospitalization
|
4.0%
1/25 • Number of events 1 • 6 months
It does not differ from clinicaltrials.gov definitions
|
0.00%
0/26 • 6 months
It does not differ from clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Medical Hospitalization
|
4.0%
1/25 • Number of events 1 • 6 months
It does not differ from clinicaltrials.gov definitions
|
0.00%
0/26 • 6 months
It does not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Medical Hospitalization
|
4.0%
1/25 • Number of events 1 • 6 months
It does not differ from clinicaltrials.gov definitions
|
0.00%
0/26 • 6 months
It does not differ from clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Medical Hospitalization
|
4.0%
1/25 • Number of events 1 • 6 months
It does not differ from clinicaltrials.gov definitions
|
0.00%
0/26 • 6 months
It does not differ from clinicaltrials.gov definitions
|
Other adverse events
| Measure |
tDCS and Aerobic Exercise
n=25 participants at risk
Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
Sham tDCS and Aerobic Exercise
n=26 participants at risk
Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.
Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • 6 months
It does not differ from clinicaltrials.gov definitions
|
3.8%
1/26 • Number of events 1 • 6 months
It does not differ from clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
knee injury
|
4.0%
1/25 • Number of events 1 • 6 months
It does not differ from clinicaltrials.gov definitions
|
0.00%
0/26 • 6 months
It does not differ from clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place