An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy (MIGHTY)

February 13, 2018 updated by: Georgetown University

An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will assess the feasibility of an exercise intervention to counteract adverse side effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI), hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial, 40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching control group (n=20) with a follow-up at 8-weeks.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • Office of Minority Health and Health Disparities Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • (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

Exclusion Criteria:

  • (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
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
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.
Active Comparator: Stretching Control group
Informational booklet containing stretching exercises (20-minutes a day)
Behavioral: Stretching Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density
Time Frame: 8-weeks
BMD will be measured by a DXA scan
8-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Fitness
Time Frame: 8-weeks
. The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart
8-weeks
Muscle strength
Time Frame: 8-weeks
Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer
8-weeks
Step Count
Time Frame: 8-weeks
The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.
8-weeks
Quality of Life (HRQOL)
Time Frame: 8-weeks
The 10-item PROMIS® Global Health Scale will be used to assess key HRQOL domains including pain, fatigue, mental health, physical health, social health, and overall health
8-weeks
Hip/Waist Circumference
Time Frame: 8-weeks
Anthropometric measures
8-weeks
Body Mass Index (BMI)
Time Frame: 8-weeks
BMI will be measured according to height and weight
8-weeks
Glucose/Lipid levels
Time Frame: 8-weeks
A fasting finger stick sample of blood (35 μl) will be assessed for immediate analysis of lipid panel (i.e., total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides) and fasting glucose
8-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

American Cancer Society, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Georgetown_University_MC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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