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Clinical Trials/NCT01715064
NCT01715064
Completed
Phase 2

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

University of Guelph-Humber1 site in 1 country36 target enrollmentJuly 2012
ConditionsProstate Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University of Guelph-Humber
Enrollment
36
Locations
1
Primary Endpoint
Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Santa Mina

Assistant Program Head, Kinesiology

University of Guelph-Humber

Eligibility 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)

Outcomes

Primary Outcomes

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 Outcomes

  • Profile of Mood States Questionnaire(PoMS)(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)(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)(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)(10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)

Study Sites (1)

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