Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer
NCT ID: NCT02179762
Last Updated: 2018-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-08-09
2018-07-23
Brief Summary
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Detailed Description
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I. To determine the feasibility of performing vigorous intensity aerobic exercise using progressive, high-intensity interval training (HIIT) with standard stationary cycling and 'cybercycling' compared to moderate intensity aerobic exercise with standard stationary cycling in prostate cancer (PCa) survivors on active surveillance (AS).
II. To explore the potential effects of vigorous intensity aerobic exercise (HIIT) using standard cycling and 'cybercycling' compared to moderate intensity standard cycling on changes in quality of life (QoL), cognition, fitness circulating inflammatory biomarkers and PCa-specific markers of progression (prostate specific antigen \[PSA\], time to AT) in PCa survivors in active surveillance (AS); and, to explore if these effects may be mediated by changes in body fat.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
ARM II: Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
ARM III: Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
After completion of study, patients are followed up at 6 and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (moderate intensity exercise)
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
moderate exercise intervention
Perform moderate exercise therapy
questionnaire administration
Ancillary studies: Functional Assessment of Cancer Therapy-General (FACT-G), Godin Leisure-Time Exercise questionnaire, 24-hour diet recalls, USDA 5 Step Multiple Pass Method, Memorial Anxiety Scale for Prostate Cancer, Pittsburgh Sleep Quality Index (PSQI)
laboratory biomarker analysis
Correlative studies
Exercise Logs
The exercise physiologists will keep exercise logs and tracking sheets that log the date, start and stop time (duration) of exercise sessions as well as time in the THR and RPE for each exercise session.
Adherence
We will assess barriers to adhering to the exercise protocol by asking an open-ended question to solicit barriers. If the patient calls to cancel an exercise session, he will be called and probed for reasons
Exercise and body composition test
Height will be measured to the nearest 0.1 cm and weight will be measured to the nearest 0.1 kg. Waist and hip circumference will be measured to the nearest 1/8 inch. Whole body dual-energy X-ray absorptiometry scans will be conducted at baseline and end of treatment to quantify total body fat.
Arm II (HIIT exercise on a standard stationary bike)
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
vigorous exercise intervention - standard
Perform HIIT exercise therapy on a standard stationary bike
questionnaire administration
Ancillary studies: Functional Assessment of Cancer Therapy-General (FACT-G), Godin Leisure-Time Exercise questionnaire, 24-hour diet recalls, USDA 5 Step Multiple Pass Method, Memorial Anxiety Scale for Prostate Cancer, Pittsburgh Sleep Quality Index (PSQI)
laboratory biomarker analysis
Correlative studies
Exercise Logs
The exercise physiologists will keep exercise logs and tracking sheets that log the date, start and stop time (duration) of exercise sessions as well as time in the THR and RPE for each exercise session.
Adherence
We will assess barriers to adhering to the exercise protocol by asking an open-ended question to solicit barriers. If the patient calls to cancel an exercise session, he will be called and probed for reasons
Exercise and body composition test
Height will be measured to the nearest 0.1 cm and weight will be measured to the nearest 0.1 kg. Waist and hip circumference will be measured to the nearest 1/8 inch. Whole body dual-energy X-ray absorptiometry scans will be conducted at baseline and end of treatment to quantify total body fat.
Arm III (HIIT exercise on a cybercycle)
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
questionnaire administration
Ancillary studies: Functional Assessment of Cancer Therapy-General (FACT-G), Godin Leisure-Time Exercise questionnaire, 24-hour diet recalls, USDA 5 Step Multiple Pass Method, Memorial Anxiety Scale for Prostate Cancer, Pittsburgh Sleep Quality Index (PSQI)
laboratory biomarker analysis
Correlative studies
vigorous exercise intervention - cybercycling
perform HIIT exercise on cybercycles aided by electronic racing and other games
Exercise Logs
The exercise physiologists will keep exercise logs and tracking sheets that log the date, start and stop time (duration) of exercise sessions as well as time in the THR and RPE for each exercise session.
Adherence
We will assess barriers to adhering to the exercise protocol by asking an open-ended question to solicit barriers. If the patient calls to cancel an exercise session, he will be called and probed for reasons
Exercise and body composition test
Height will be measured to the nearest 0.1 cm and weight will be measured to the nearest 0.1 kg. Waist and hip circumference will be measured to the nearest 1/8 inch. Whole body dual-energy X-ray absorptiometry scans will be conducted at baseline and end of treatment to quantify total body fat.
Interventions
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moderate exercise intervention
Perform moderate exercise therapy
vigorous exercise intervention - standard
Perform HIIT exercise therapy on a standard stationary bike
questionnaire administration
Ancillary studies: Functional Assessment of Cancer Therapy-General (FACT-G), Godin Leisure-Time Exercise questionnaire, 24-hour diet recalls, USDA 5 Step Multiple Pass Method, Memorial Anxiety Scale for Prostate Cancer, Pittsburgh Sleep Quality Index (PSQI)
laboratory biomarker analysis
Correlative studies
vigorous exercise intervention - cybercycling
perform HIIT exercise on cybercycles aided by electronic racing and other games
Exercise Logs
The exercise physiologists will keep exercise logs and tracking sheets that log the date, start and stop time (duration) of exercise sessions as well as time in the THR and RPE for each exercise session.
Adherence
We will assess barriers to adhering to the exercise protocol by asking an open-ended question to solicit barriers. If the patient calls to cancel an exercise session, he will be called and probed for reasons
Exercise and body composition test
Height will be measured to the nearest 0.1 cm and weight will be measured to the nearest 0.1 kg. Waist and hip circumference will be measured to the nearest 1/8 inch. Whole body dual-energy X-ray absorptiometry scans will be conducted at baseline and end of treatment to quantify total body fat.
Eligibility Criteria
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Inclusion Criteria
* Approved to be contacted by the treating urologist
* Meet screening criteria
* Complete American Heart Association (AHA)/American College of Sports Medicine (ACSM) exercise questionnaire
* Undergo cardiopulmonary exercise (CPX) testing utilizing a cycle ergometer. If the CPX test is terminated secondary to hemodynamic instability, arrhythmias or ischemic signs, the patient will be ineligible.
Exclusion Criteria
* Patients participating in a structured exercise program in the past 6 months
* Patients not available for follow-up tests
* Patients with pre-existing medical conditions that would be a barrier to exercise
18 Years
75 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nora Nock, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Other Identifiers
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NCI-2014-01313
Identifier Type: REGISTRY
Identifier Source: secondary_id
CASE9814
Identifier Type: OTHER
Identifier Source: secondary_id
CASE9814
Identifier Type: -
Identifier Source: org_study_id
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