Exercise Training Among Men With Prostate Cancer

NCT00620932 | Withdrawn

• 1 other identifier: Pro00002501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the feasibility and acceptability of a home-based endurance exercise program among men diagnosed with clinically localized prostate cancer.

Conditions

Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring.

  6 months

Secondary Outcomes (1)

• Fasting lipids will be assessed.

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

These patients will continue with whatever routine exercise they already engage in.

Exercise Arm

EXPERIMENTAL

These patients will participate in a controlled, supervised exercise program.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Patients will be randomly assigned to groups and will either be given an exercise program individually tailored to them for them to participate in for 6 months or else be wait-listed for 6 months and remain on whatever exercise regimen they were already on.

Exercise Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Legal age (\>18 years old)
• An interval of at least 6 weeks between prior radical prostatectomy and study enrollment
• Karnofsky performance status of at least 70% at study entry
• Estimated life expectancy of ≥6 months
• Ability to read and understand English
• Attending urologist approval
• Signed informed consent
• Willingness to be randomized; and
• No contraindications to exercise as recommended by the American Thoracic Society

You may not qualify if:

• Acute myocardial infarction (6 weeks)
• Unstable angina
• Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
• Syncope
• Acute endocarditis
• Acute myocarditis or pericarditis
• Uncontrolled heart failure
• Acute pulmonary embolus or pulmonary infarction
• Thrombosis of lower extremities
• Suspected dissecting aneurysm
• Uncontrolled asthma
• Pulmonary edema
• Room air desaturation at rest ≤85%
• Respiratory failure
• Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise; and

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Jones LW, Hornsby WE, Freedland SJ, Lane A, West MJ, Moul JW, Ferrandino MN, Allen JD, Kenjale AA, Thomas SM, Herndon JE 2nd, Koontz BF, Chan JM, Khouri MG, Douglas PS, Eves ND. Effects of nonlinear aerobic training on erectile dysfunction and cardiovascular function following radical prostatectomy for clinically localized prostate cancer. Eur Urol. 2014 May;65(5):852-5. doi: 10.1016/j.eururo.2013.11.009. Epub 2013 Nov 22.

  PMID: 24315706 DERIVED

Related Links

• Preston Robert Tisch Brain Tumor Center at Duke

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lee Jones, PHd

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 28, 2013

Record last verified: 2013-10

Locations

US (1)