Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Behavioral: Exercise |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients |
- 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'). ] [ Designated as safety issue: No ]CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.
- 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'). ] [ Designated as safety issue: No ]Correlations will be assessed between cortical silent period and acute mood state.
- 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'). ] [ Designated as safety issue: No ]Correlations will be assessed between cortical silent period and acute anxiety.
- 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'). ] [ Designated as safety issue: No ]Correlations will be assessed between cortical silent period and acute anxiety and depression.
- 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'). ] [ Designated as safety issue: No ]Correlations will be assessed between cortical silent period and exercise-induced feelings.
| Estimated Enrollment: | 36 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
non-exercise control consisting of movie watching.
|
|
|
Experimental: Exercise
1 hour of moderate intensity exercise.
|
Behavioral: Exercise
1 hour of moderate-intensity exercise
|
Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Daniel Santa Mina, PhD (cand) | 416-340-4800 ext 3957 | daniel.sta.mina@uhn.ca |
| Contact: Paul Ritvo, PhD | 416-971-9800 ext 3203 | paul.ritvo@cancercare.on.ca |
| Canada, Ontario | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Principal Investigator: Daniel Santa Mina, PhD (cand) | |
More Information
No publications provided
| Responsible Party: | Daniel Santa Mina, Assistant Program Head, Kinesiology, University of Guelph-Humber |
| ClinicalTrials.gov Identifier: | NCT01715064 History of Changes |
| Other Study ID Numbers: | PCA_CSP2012 |
| Study First Received: | October 9, 2012 |
| Last Updated: | October 23, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Guelph-Humber:
|
Prostate Cancer Exercise Cortical Inhibition Cortical Silent Period Transcranial Magnetic Stimulation |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013