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Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT01715064
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : February 10, 2014
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Daniel Santa Mina, University of Guelph-Humber

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Prostate Cancer
Intervention Behavioral: Exercise
Enrollment 36
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Control (1hr of Viewing Emotionally Neutral Movie) Exercise (1hr of Mixed-modality Exercise)
Hide Arm/Group Description non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral. 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.
Period Title: Overall Study
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title Control Exercise Total
Hide Arm/Group Description non-exercise control consisting of movie watching. 1 hour of moderate intensity exercise. Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  72.2%
15
  83.3%
28
  77.8%
>=65 years
5
  27.8%
3
  16.7%
8
  22.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
61.6  (9.1) 67.7  (7.6) 64.6  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
18
 100.0%
18
 100.0%
36
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 18 participants 18 participants 36 participants
18 18 36
1.Primary Outcome
Title Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.
Hide Description CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.
Time Frame 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Exercise
Hide Arm/Group Description:
non-exercise control consisting of movie watching.
1 hour of moderate intensity exercise.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: seconds
0.001  (0.025) 0.006  (0.019)
2.Secondary Outcome
Title Profile of Mood States Questionnaire(PoMS)
Hide Description Correlations will be assessed between cortical silent period and acute mood state.
Time Frame 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
Outcome Measure Data Not Reported
3.Secondary Outcome
Title State-Trait Anxiety Inventory - Questionnaire(STAI)
Hide Description Correlations will be assessed between cortical silent period and acute anxiety.
Time Frame 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Hospital Anxiety and Depression Scale - Questionnaire(HADS)
Hide Description Correlations will be assessed between cortical silent period and acute anxiety and depression.
Time Frame 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Exercise-Induced Feelings Inventory - Questionnaire (EIFI)
Hide Description Correlations will be assessed between cortical silent period and exercise-induced feelings.
Time Frame 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
Outcome Measure Data Not Reported
Time Frame 7 months.
Adverse Event Reporting Description Serious adverse and other adverse events were collected during participants' activity in the trial (i.e. the pre-treatment assessment, during the exercise or video sessions, and during the post-treatment assessment).
 
Arm/Group Title Control Exercise
Hide Arm/Group Description non-exercise control consisting of movie watching. 1 hour of moderate intensity exercise.
All-Cause Mortality
Control Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Daniel Santa Mina
Organization: University of Guelph-Humber
Phone: 416-798-1331 ext 6065
Responsible Party: Daniel Santa Mina, University of Guelph-Humber
ClinicalTrials.gov Identifier: NCT01715064     History of Changes
Other Study ID Numbers: PCA_CSP2012
First Submitted: October 9, 2012
First Posted: October 26, 2012
Results First Submitted: May 24, 2013
Results First Posted: February 10, 2014
Last Update Posted: February 10, 2014