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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715064
• Other study ID #: PCA_CSP2012
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 9, 2012
• Last updated: January 12, 2014
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: University of Guelph-Humber
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Exercise
1 hour of moderate-intensity exercise

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph-Humber

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.	CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	No
Secondary	Profile of Mood States Questionnaire(PoMS)	Correlations will be assessed between cortical silent period and acute mood state.	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	No
Secondary	State-Trait Anxiety Inventory - Questionnaire(STAI)	Correlations will be assessed between cortical silent period and acute anxiety.	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	No
Secondary	Hospital Anxiety and Depression Scale - Questionnaire(HADS)	Correlations will be assessed between cortical silent period and acute anxiety and depression.	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	No
Secondary	Exercise-Induced Feelings Inventory - Questionnaire (EIFI)	Correlations will be assessed between cortical silent period and exercise-induced feelings.	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	No