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

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Georgetown University

Status

Completed

Conditions

Physical Activity
Side-effects
Prostate Cancer

Treatments

Behavioral: Supervised and Home Based Exercise
Behavioral: Stretching Control Group

Study type

Interventional

Funder types

Other

Identifiers

NCT02248350
Georgetown_University_MC

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

Male

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

19 participants in 2 patient groups

Exercise Group
Experimental group
Description:
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
Treatment:
Behavioral: Supervised and Home Based Exercise
Stretching Control group
Active Comparator group
Description:
Informational booklet containing stretching exercises (20-minutes a day)
Treatment:
Behavioral: Stretching Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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