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


Phase 2/Phase 3
45 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Change from baseline in Cortical Silent Period (CSP) will be determined using Transcranial Magnetic Stimulation (TMS) of the motor cortex.

Outcome Description:

CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.

Outcome Time Frame:

10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').

Safety Issue:

No

Authority:

Canada: Ethics Review Committee

Study ID:

PCA_CSP2012

NCT ID:

NCT01715064

Start Date:

July 2012

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Exercise
  • Cortical Inhibition
  • Cortical Silent Period
  • Transcranial Magnetic Stimulation
  • Prostatic Neoplasms

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