Trial Outcomes & Findings for Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients (NCT NCT01715064)
NCT ID: NCT01715064
Last Updated: 2014-02-10
Results Overview
CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.
COMPLETED
PHASE2/PHASE3
36 participants
10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
2014-02-10
Participant Flow
Eligible patients were approached for participation by a research coordinator from June to October, 2010. 86 eligible participants were approached for participation and 19 agreed (22% participation rate). Seventeen participants responded to the study poster. The 36 participants were randomly assigned to the exercise (n=18) or control (n=18) group.
Participant milestones
| Measure |
Control (1hr of Viewing Emotionally Neutral Movie)
non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral.
|
Exercise (1hr of Mixed-modality Exercise)
1 hour of moderate intensity exercise. The session included 5- min warm-up, 25-min of resistance training, 25-min of aerobic training, and 5-min cool-down. Each session was led by a personal trainer and supervised by an exercise physiologist.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Control
n=18 Participants
non-exercise control consisting of movie watching.
|
Exercise
n=18 Participants
1 hour of moderate intensity exercise.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.
Outcome measures
| Measure |
Control
n=18 Participants
non-exercise control consisting of movie watching.
|
Exercise
n=18 Participants
1 hour of moderate intensity exercise.
|
|---|---|---|
|
Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.
|
0.001 seconds
Standard Deviation 0.025
|
0.006 seconds
Standard Deviation 0.019
|
SECONDARY outcome
Timeframe: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').Correlations will be assessed between cortical silent period and acute mood state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').Correlations will be assessed between cortical silent period and acute anxiety.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').Correlations will be assessed between cortical silent period and acute anxiety and depression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').Correlations will be assessed between cortical silent period and exercise-induced feelings.
Outcome measures
Outcome data not reported
Adverse Events
Control
Exercise
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place