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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer, Exercise, Cortical Inhibition, Cortical Silent Period, Transcranial Magnetic Stimulation

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)MaleDoes not accept 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)

Sites / Locations

University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Exercise

Arm Description

non-exercise control consisting of movie watching.

1 hour of moderate intensity exercise.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Profile of Mood States Questionnaire(PoMS)

Correlations will be assessed between cortical silent period and acute mood state.

State-Trait Anxiety Inventory - Questionnaire(STAI)

Correlations will be assessed between cortical silent period and acute anxiety.

Hospital Anxiety and Depression Scale - Questionnaire(HADS)

Correlations will be assessed between cortical silent period and acute anxiety and depression.

Exercise-Induced Feelings Inventory - Questionnaire (EIFI)

Correlations will be assessed between cortical silent period and exercise-induced feelings.

Full Information

NCT ID

NCT01715064

First Posted

October 9, 2012

Last Updated

January 12, 2014

Sponsor

University of Guelph-Humber

1. Study Identification

Unique Protocol Identification Number

NCT01715064

Brief Title

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Guelph-Humber

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate Cancer, Exercise, Cortical Inhibition, Cortical Silent Period, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

non-exercise control consisting of movie watching.

Arm Title

Exercise

Arm Type

Experimental

Arm Description

1 hour of moderate intensity exercise.

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

1 hour of moderate-intensity exercise

Primary Outcome Measure Information:

Title

Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.

Description

CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.

Time Frame

10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').

Secondary Outcome Measure Information:

Title

Profile of Mood States Questionnaire(PoMS)

Description

Correlations will be assessed between cortical silent period and acute mood state.

Time Frame

10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').

Title

State-Trait Anxiety Inventory - Questionnaire(STAI)

Description

Correlations will be assessed between cortical silent period and acute anxiety.

Time Frame

10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').

Title

Hospital Anxiety and Depression Scale - Questionnaire(HADS)

Description

Correlations will be assessed between cortical silent period and acute anxiety and depression.

Time Frame

10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').

Title

Exercise-Induced Feelings Inventory - Questionnaire (EIFI)

Description

Correlations will be assessed between cortical silent period and exercise-induced feelings.

Time Frame

10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25505413

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.

Results Reference

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

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