Clinical trial NCT01715064: Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients
Official title: Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Exercise
Cortical Inhibition
Cortical Silent Period
Transcranial Magnetic Stimulation
Lead sponsor: University of Guelph-Humber
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 36
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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)

Primary outcomes:
measure: Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.
timeFrame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
Secondary outcomes:
measure: Profile of Mood States Questionnaire(PoMS)
timeFrame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
measure: State-Trait Anxiety Inventory - Questionnaire(STAI)
timeFrame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
measure: Hospital Anxiety and Depression Scale - Questionnaire(HADS)
timeFrame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
measure: Exercise-Induced Feelings Inventory - Questionnaire (EIFI)
timeFrame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
citation: Santa Mina D, Guglietti CL, de Jesus DR, Azargive S, Matthew AG, Alibhai SM, Trachtenberg J, Daskalakis JZ, Ritvo P. The acute effects of exercise on cortical excitation and psychosocial outcomes in men treated for prostate cancer: a randomized controlled trial. Front Aging Neurosci. 2014 Nov 26;6:332. doi: 10.3389/fnagi.2014.00332. eCollection 2014.