- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01715064
Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients
January 12, 2014 updated by: Daniel Santa Mina, University of Guelph-Humber
In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third leading cause of cancer-related death.
Unfortunately, PCa survivors are often burdened with feelings of anxiety and depression associated with the disease and associated treatments.
Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this population, but the impact of single bouts of exercise and related psychological or neurological changes have never been studied.
The primary objective of the proposed study is to examine the effect of an acute bout of exercise on neurophysiological and psychological indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa.
Participants will be randomly assigned to the intervention (60 min exercise) or control (60 min of television) and will undergo a brief neurological test (cortical silent period) and psychological questionnaires before and after their group assignment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Histologically confirmed PCa;
- > 6 months post curative therapy for PCa (radical prostatectomy or radiation therapy) with or without adjuvant androgen deprivation therapy;
- Willing and able to provide informed consent;
- If metastatic disease is present, they are asymptomatic; v) n
- No contraindications to exercise
Exclusion Criteria:
- Severe coronary artery disease (Canadian Cardiovascular Society class III or greater);
- Significant congestive heart failure (New York Heart Association class III or greater);
- Uncontrolled pain;
- Neurological or musculoskeletal co-morbidity inhibiting exercise;
- Diagnosed psychotic, addictive, or major cognitive disorders or are currently or have a history of using psychotropic medication (anti-depressants, anti-anxiety, anti-psychotics, benzodiazepines, etc);
- Contraindications to magnetic exposure (surgical clips in the brain; cardiac pace maker or valves; cochlear implants; metal rods, plates, screws in head; shrapnel/metal fragments in head/eyes; dentures);
- Prior history of seizures or diagnosis of epilepsy;
- Left-hand dominant; and
No more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine[41, 42]:
- Family history of coronary disease, cigarette smoking, hypertension (Systolic Blood Pressure (SBP) > 140 mmHg; Diastolic Blood Pressure (DBP) > 90 mmHg), known dyslipidemia, known impaired fasting, glucose (>110 mg/dL), obesity (BMI > 30 kg/m2 or waist circumference > 102cm), or physically inactive (<150 min of moderate intensity physical activity per week)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
non-exercise control consisting of movie watching.
|
|
Experimental: Exercise
1 hour of moderate intensity exercise.
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1 hour of moderate-intensity exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.
Time Frame: 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.
|
10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Profile of Mood States Questionnaire(PoMS)
Time Frame: 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.
|
10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
|
State-Trait Anxiety Inventory - Questionnaire(STAI)
Time Frame: 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.
|
10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
|
Hospital Anxiety and Depression Scale - Questionnaire(HADS)
Time Frame: 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.
|
10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
|
Exercise-Induced Feelings Inventory - Questionnaire (EIFI)
Time Frame: 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.
|
10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
October 9, 2012
First Submitted That Met QC Criteria
October 23, 2012
First Posted (Estimate)
October 26, 2012
Study Record Updates
Last Update Posted (Estimate)
February 10, 2014
Last Update Submitted That Met QC Criteria
January 12, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCA_CSP2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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