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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Santa Mina, University of Guelph-Humber
ClinicalTrials.gov Identifier:
NCT01715064
First received: October 9, 2012
Last updated: January 12, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by 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'). ] [ Designated as safety issue: No ]
    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'). ] [ 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.


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

Ages Eligible for Study:   45 Years to 85 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715064

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University of Guelph-Humber
  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
Results First Received: May 24, 2013
Last Updated: January 12, 2014
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 August 19, 2014