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Completed

NCT Number: NCT01715064

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

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.

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Key information

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

1 hour of moderate-intensity exercise

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Guelph-Humber

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2012
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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