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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01715064
First Posted: October 26, 2012
Last Update Posted: February 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Santa Mina, University of Guelph-Humber
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Daniel Santa Mina, University of Guelph-Humber:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 36
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715064


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University of Guelph-Humber
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
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
Last Verified: January 2014

Keywords provided by Daniel Santa Mina, 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


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