Phase 3 N=36 Randomized Single-blind Supportive Care

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

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01715064 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex. — 0.001; 0.006 seconds

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Exercise (Behavioral)
Age: Adult, Older Adult · 45+ yrs
Sex: Male
Sponsor: University of Guelph-Humber
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.	0.001; 0.006	—
SECONDARY Profile of Mood States Questionnaire(PoMS)	—	—
SECONDARY State-Trait Anxiety Inventory - Questionnaire(STAI)	—	—
SECONDARY Hospital Anxiety and Depression Scale - Questionnaire(HADS)	—	—
SECONDARY Exercise-Induced Feelings Inventory - Questionnaire (EIFI)	—	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01715064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.