Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer

Not Applicable

Withdrawn

• Conditions: Recurrent Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage I Prostate Cancer
• Interventions: Behavioral: vigorous exercise intervention - standard; Behavioral: moderate exercise intervention; Other: questionnaire administration; Other: laboratory biomarker analysis; Behavioral: vigorous exercise intervention - cybercycling; Behavioral: Exercise Logs; Behavioral: Adherence; Behavioral: Exercise and body composition test

• Registration Number: NCT02179762
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-02
• Study Start: 2014-08-09
• Primary Completion: 2018-07-23
• Study Completion: 2018-07-23
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (HIIT exercise on a standard stationary bike)	vigorous exercise intervention - standard	Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
Arm II (HIIT exercise on a standard stationary bike)	Adherence	Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
Arm I (moderate intensity exercise)	Adherence	Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
Arm II (HIIT exercise on a standard stationary bike)	Exercise Logs	Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
Arm I (moderate intensity exercise)	moderate exercise intervention	Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
Arm I (moderate intensity exercise)	laboratory biomarker analysis	Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
Arm III (HIIT exercise on a cybercycle)	Exercise and body composition test	Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
Arm I (moderate intensity exercise)	questionnaire administration	Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
Arm I (moderate intensity exercise)	Exercise Logs	Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
Arm II (HIIT exercise on a standard stationary bike)	questionnaire administration	Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
Arm I (moderate intensity exercise)	Exercise and body composition test	Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
Arm II (HIIT exercise on a standard stationary bike)	laboratory biomarker analysis	Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
Arm III (HIIT exercise on a cybercycle)	laboratory biomarker analysis	Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
Arm II (HIIT exercise on a standard stationary bike)	Exercise and body composition test	Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
Arm III (HIIT exercise on a cybercycle)	Exercise Logs	Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
Arm III (HIIT exercise on a cybercycle)	questionnaire administration	Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
Arm III (HIIT exercise on a cybercycle)	Adherence	Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
Arm III (HIIT exercise on a cybercycle)	vigorous exercise intervention - cybercycling	Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Overall attendance	Up to 16 weeks	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	Up to 16 weeks	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	Up to 16 weeks	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

Name	Time	Method
Average change in the Exercise Motivations Inventory (EMI-2)	Baseline up to 16 weeks	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 body mass index as a measure of body composition	Baseline up to 16 weeks	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 quality of life, measured using the Functional Assessment of Cancer Therapy (FACT)	Baseline up to 16 weeks	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	Baseline up to 16 weeks	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 cognition	Baseline up to 16 weeks	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	Baseline up to 16 weeks	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	Baseline up to 16 weeks	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in insulin	Baseline up to 16 weeks	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in adiponectin	Baseline up to 16 weeks	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in IGF-1	Baseline up to 16 weeks	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in resistin	Baseline up to 16 weeks	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in IGFBP-3	Baseline up to 16 weeks	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in TNF-alpha	Baseline up to 16 weeks	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in waist/hip circumference ratio as a measure of body composition	Baseline up to 16 weeks	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	Baseline up to 16 weeks	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.
Change in IGFBP-1	Baseline up to 16 weeks	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)	Baseline up to 16 weeks	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.