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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | non-exercise control consisting of movie watching. | |
| Exercise | Experimental | 1 hour of moderate intensity exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 1 hour of moderate-intensity exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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'). |
| Measure | Description | Time Frame |
|---|---|---|
| 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'). |
| State-Trait Anxiety Inventory - Questionnaire(STAI) |
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Inclusion Criteria:
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]:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25505413 | Derived | 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. |
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Eligible patients were approached for participation by a research coordinator from June to October, 2010. 86 eligible participants were approached for participation and 19 agreed (22% participation rate). Seventeen participants responded to the study poster. The 36 participants were randomly assigned to the exercise (n=18) or control (n=18) group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (1hr of Viewing Emotionally Neutral Movie) | non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral. |
| FG001 | Exercise (1hr of Mixed-modality Exercise) | 1 hour of moderate intensity exercise. The session included 5- min warm-up, 25-min of resistance training, 25-min of aerobic training, and 5-min cool-down. Each session was led by a personal trainer and supervised by an exercise physiologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | non-exercise control consisting of movie watching. |
| BG001 | Exercise | 1 hour of moderate intensity exercise. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | seconds | 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test'). |
|
7 months.
Serious adverse and other adverse events were collected during participants' activity in the trial (i.e. the pre-treatment assessment, during the exercise or video sessions, and during the post-treatment assessment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | non-exercise control consisting of movie watching. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Santa Mina | University of Guelph-Humber | 416-798-1331 | 6065 | daniel.santamina@guelphhumber.ca |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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'). |
| 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'). |
| 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'). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Profile of Mood States Questionnaire(PoMS) | Correlations will be assessed between cortical silent period and acute mood state. | Not Posted | 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test'). |
| Secondary | State-Trait Anxiety Inventory - Questionnaire(STAI) | Correlations will be assessed between cortical silent period and acute anxiety. | Not Posted | 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test'). |
| Secondary | Hospital Anxiety and Depression Scale - Questionnaire(HADS) | Correlations will be assessed between cortical silent period and acute anxiety and depression. | Not Posted | 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test'). |
| Secondary | Exercise-Induced Feelings Inventory - Questionnaire (EIFI) | Correlations will be assessed between cortical silent period and exercise-induced feelings. | Not Posted | 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test'). |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Exercise | 1 hour of moderate intensity exercise. | 0 | 18 | 0 | 18 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |