NCT01715064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 10, 2014

Completed
Last Updated

February 10, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

October 9, 2012

Results QC Date

May 24, 2013

Last Update Submit

January 12, 2014

Conditions

Prostate Cancer

Keywords

Prostate CancerExerciseCortical InhibitionCortical Silent PeriodTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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').

Secondary Outcomes (4)

  • 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').

  • 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').

  • 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').

  • 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').

Study Arms (2)

Control

NO INTERVENTION

non-exercise control consisting of movie watching.

Exercise

EXPERIMENTAL

1 hour of moderate intensity exercise.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

1 hour of moderate-intensity exercise

Exercise

Eligibility Criteria

Age45 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25505413DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Daniel Santa Mina
Organization
University of Guelph-Humber
daniel.santamina@guelphhumber.ca
416-798-1331

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Program Head, Kinesiology

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 26, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

February 10, 2014

Results First Posted

February 10, 2014

Record last verified: 2014-01

Locations

CA(1)