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

NCT ID: NCT01715064

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-05-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

non-exercise control consisting of movie watching.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise

1 hour of moderate intensity exercise.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

1 hour of moderate-intensity exercise

Interventions

Exercise

1 hour of moderate-intensity exercise

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Guelph-Humber

OTHER

Sponsor Role: lead

Responsible Party

Daniel Santa Mina

Assistant Program Head, Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25505413 (View on PubMed)

Other Identifiers

PCA_CSP2012

Identifier Type: -

Identifier Source: org_study_id