Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer (EASE)
Primary Purpose
Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
moderate exercise intervention
vigorous exercise intervention - standard
questionnaire administration
laboratory biomarker analysis
vigorous exercise intervention - cybercycling
Exercise Logs
Adherence
Exercise and body composition test
Sponsored by
About this trial
This is an interventional supportive care trial for Recurrent Prostate Cancer focused on measuring cancer survivor, prostate cancer, exercise, Active surveillance, EASE
Eligibility Criteria
Inclusion Criteria:
- Adult men of all races and body size with histologically confirmed localized PCa on AS
- 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 unable to provide informed consent
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm I (moderate intensity exercise)
Arm II (HIIT exercise on a standard stationary bike)
Arm III (HIIT exercise on a cybercycle)
Arm Description
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
Outcomes
Primary Outcome Measures
Overall attendance
Average number of people who attend each session
Overall adherence to the exercise protocol as measured by average time in HIIT intervals for HIIT groups
Average number of minutes in HIIT intervals which are defined as exercising at 80-90% WR_peak
Adherence to the exercise protocol as measured by average time in the target heart rate (THR) zone
the target heart rate zone will be determined using the Karvonen formula: THR=((HRmax - HRrest) × % Intensity) + HRrest. Total time in this zone will be recorded every 5 minutes and the overall average will be recorded
Secondary Outcome Measures
Average change in the Exercise Motivations Inventory (EMI-2)
The EMI-2 is a validated, 51 item instrument where each question is scored 0-5 and higher scores indicate greater motivation. Average changes will be analyzed using t-tests as well as mixed linear models adjusted for potential confounding factors.
Change in quality of life, measured using the Functional Assessment of Cancer Therapy (FACT)
A 25 item scale scored 0-4 where lower indicate greater quality of life. Paired t-tests will be used to evaluate change as well as mixed linear models adjusted for potential confounding factors.
Average change in fitness
Difference in VO2 maximum 30 second intake from beginning of study to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in body mass index as a measure of body composition
Change in body mass index (function of height and weight) from baseline to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in cognition
Average change in score of cognitive survey. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in eating behaviors
61 items where higher scores indicate healthier eating behaviors. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in leptin
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in insulin
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in adiponectin
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in resistin
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in IGF-1
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in IGFBP-1
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in IGFBP-3
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in TNF-alpha
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Average change in the Exercise Causality Orientations Scale (ECOS)
The ECOS is a validated, 21 item instrument where each question is scored 1-7 and higher scores indicate greater motivation. Average changes will be analyzed using t-tests as well as mixed linear models adjusted for potential confounding factors.
Change in waist/hip circumference ratio as a measure of body composition
Change in waist and hip circumference ratio from baseline to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in total body fat as a measure of body composition
Change in total body fat from baseline to end of treatment as measured by whole body dual-energy X-ray absorptiometry scans. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Full Information
NCT ID
NCT02179762
First Posted
June 30, 2014
Last Updated
August 8, 2018
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02179762
Brief Title
Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer
Acronym
EASE
Official Title
Enhancing Active Surveillance With Exercise (EASE): A Pilot Randomized Trial in Localized Prostate Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient staff
Study Start Date
August 9, 2014 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
July 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing active surveillance in patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Active surveillance involves watching the patient's condition but not giving any treatment unless test results show that the patient's condition is getting worse. Exercise may improve fitness, quality of life, brain health, and blood biomarkers in patients with prostate cancer on active surveillance. It is not yet known whether vigorous or moderate exercise works better in enhancing active surveillance in patients with localized prostate cancer.
Detailed Description
PRIMARY OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
Keywords
cancer survivor, prostate cancer, exercise, Active surveillance, EASE
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (moderate intensity exercise)
Arm Type
Experimental
Arm Description
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
Arm Title
Arm II (HIIT exercise on a standard stationary bike)
Arm Type
Experimental
Arm Description
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
Arm Title
Arm III (HIIT exercise on a cybercycle)
Arm Type
Experimental
Arm Description
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
Intervention Type
Behavioral
Intervention Name(s)
moderate exercise intervention
Intervention Description
Perform moderate exercise therapy
Intervention Type
Behavioral
Intervention Name(s)
vigorous exercise intervention - standard
Intervention Description
Perform HIIT exercise therapy on a standard stationary bike
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Behavioral
Intervention Name(s)
vigorous exercise intervention - cybercycling
Intervention Description
perform HIIT exercise on cybercycles aided by electronic racing and other games
Intervention Type
Behavioral
Intervention Name(s)
Exercise Logs
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Adherence
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Exercise and body composition test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall attendance
Description
Average number of people who attend each session
Time Frame
Up to 16 weeks
Title
Overall adherence to the exercise protocol as measured by average time in HIIT intervals for HIIT groups
Description
Average number of minutes in HIIT intervals which are defined as exercising at 80-90% WR_peak
Time Frame
Up to 16 weeks
Title
Adherence to the exercise protocol as measured by average time in the target heart rate (THR) zone
Description
the target heart rate zone will be determined using the Karvonen formula: THR=((HRmax - HRrest) × % Intensity) + HRrest. Total time in this zone will be recorded every 5 minutes and the overall average will be recorded
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Average change in the Exercise Motivations Inventory (EMI-2)
Description
The EMI-2 is a validated, 51 item instrument where each question is scored 0-5 and higher scores indicate greater motivation. Average changes will be analyzed using t-tests as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in quality of life, measured using the Functional Assessment of Cancer Therapy (FACT)
Description
A 25 item scale scored 0-4 where lower indicate greater quality of life. Paired t-tests will be used to evaluate change as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Average change in fitness
Description
Difference in VO2 maximum 30 second intake from beginning of study to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in body mass index as a measure of body composition
Description
Change in body mass index (function of height and weight) from baseline to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in cognition
Description
Average change in score of cognitive survey. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in eating behaviors
Description
61 items where higher scores indicate healthier eating behaviors. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in leptin
Description
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in insulin
Description
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in adiponectin
Description
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in resistin
Description
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in IGF-1
Description
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in IGFBP-1
Description
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in IGFBP-3
Description
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in TNF-alpha
Description
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Average change in the Exercise Causality Orientations Scale (ECOS)
Description
The ECOS is a validated, 21 item instrument where each question is scored 1-7 and higher scores indicate greater motivation. Average changes will be analyzed using t-tests as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in waist/hip circumference ratio as a measure of body composition
Description
Change in waist and hip circumference ratio from baseline to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
Title
Change in total body fat as a measure of body composition
Description
Change in total body fat from baseline to end of treatment as measured by whole body dual-energy X-ray absorptiometry scans. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Time Frame
Baseline up to 16 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult men of all races and body size with histologically confirmed localized PCa on AS
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 unable to provide informed consent
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Nock, PhD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer
We'll reach out to this number within 24 hrs