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

U

University of Guelph-Humber

Status and phase

Completed
Phase 3
Phase 2

Conditions

Prostate Cancer

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01715064
PCA_CSP2012

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

Male

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Control
No Intervention group
Description:
non-exercise control consisting of movie watching.
Exercise
Experimental group
Description:
1 hour of moderate intensity exercise.
Treatment:
Behavioral: Exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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