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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01715064

Enrollment

Registered

2012-10-26

Start date

2012-07-31

Completion date

2013-05-31

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

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

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.

Interventions

BEHAVIORALExercise

1 hour of moderate-intensity exercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

45 Years to 85 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.

Secondary

Measure	Time frame	Description
Profile of Mood States Questionnaire(PoMS)	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	Correlations will be assessed between cortical silent period and acute mood state.
State-Trait Anxiety Inventory - Questionnaire(STAI)	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	Correlations will be assessed between cortical silent period and acute anxiety.
Hospital Anxiety and Depression Scale - Questionnaire(HADS)	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	Correlations will be assessed between cortical silent period and acute anxiety and depression.
Exercise-Induced Feelings Inventory - Questionnaire (EIFI)	10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').	Correlations will be assessed between cortical silent period and exercise-induced feelings.

Countries

Canada

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
Control non-exercise control consisting of movie watching.	18
Exercise 1 hour of moderate intensity exercise.	18
Total	36

Baseline characteristics

Characteristic	Exercise	Control	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	3 Participants	5 Participants	8 Participants
Age, Categorical Between 18 and 65 years	15 Participants	13 Participants	28 Participants
Age, Continuous	67.7 years STANDARD_DEVIATION 7.6	61.6 years STANDARD_DEVIATION 9.1	64.6 years STANDARD_DEVIATION 8.8
Region of Enrollment Canada	18 participants	18 participants	36 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	18 Participants	18 Participants	36 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 18	0 / 18
serious Total, serious adverse events	0 / 18	0 / 18

Outcome results

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.