NCT02248350

Brief Summary

This main purpose of this study is to examine the effects of an exercise intervention to counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate cancer patients. Specifically, a supervised and home-based exercise program will be used to assess its impact on clinical and behavioral variables related to ADT in prostate cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 15, 2018

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

September 22, 2014

Last Update Submit

February 13, 2018

Conditions

Prostate CancerPhysical ActivitySide-effects

Keywords

prostate cancerphysical activityexerciseinterventionside effectsandrogen deprivation therapy

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density

    BMD will be measured by a DXA scan

    8-weeks

Secondary Outcomes (7)

  • Physical Fitness

    8-weeks

  • Muscle strength

    8-weeks

  • Step Count

    8-weeks

  • Quality of Life (HRQOL)

    8-weeks

  • Hip/Waist Circumference

    8-weeks

  • +2 more secondary outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL

8-weeks of supervised and home based exercise intervention, 3 times a week, 50-minutes a session for a total of 150/minutes a week

Behavioral: Supervised and Home Based Exercise

Stretching Control group

ACTIVE COMPARATOR

Informational booklet containing stretching exercises (20-minutes a day)

Behavioral: Stretching Control Group

Interventions

Supervised and Home Based ExerciseBEHAVIORAL

Participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise for 8-weeks. The exercise intensity will be tailored between 60-80% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11-14 on the 20-point scale.

Exercise Group
Stretching Control GroupBEHAVIORAL

Participants randomized into the control group will be provided an informational booklet with stretching techniques and exercises and will be asked to stretch at least 20-minutes a day for the duration of the study.

Stretching Control group

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) Caucasian or African-American/Black men; (2) histologically confirmed non-metastatic PCa; (3) receiving ADT treatment for 9-months or less upon recruitment (and continue to receive treatment during the duration of the study); (4) 40 to 75 years old; (5) sedentary defined as \<60 minutes of recreation or work requiring modest PA/week; (6) ability to perform the level of physical activity assessed by the Physical Activity Readiness Questionnaire (PAR-Q); (6) has access to a smartphone or computer with internet capabilities

You may not qualify if:

  • (1) severe cardiac disease; (2) recent myocardial infarction; (3) treated for any other cancer; (4) any physical, psychological illness, and/or medical problems that restricted them from exercise; (5) and not willing or able to follow procedures specified by the study and/or instructions of the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Office of Minority Health and Health Disparities Research

Washington D.C., District of Columbia, 20003, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 25, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 15, 2018

Record last verified: 2016-07

Locations

US(1)