Clinical Trials Directory

Trials / Completed

CompletedNCT04144127

Soccer Intervention in Prostate Cancer Survivors

A Soccer-based Lifestyle Intervention vs mHealth-based Physical Activity Intervention to Improve Bone Health and Metabolic Health in Prostate Cancer Survivors

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Emory University · Academic / Other
Sex
Male
Age
18 Years – 79 Years
Healthy volunteers
Not accepted

Summary

This study seeks to directly test the implementation feasibility of a soccer-based and lifestyle education intervention to determine the effects on bone health, body composition, mental health, functional and cardiometabolic status among prostate cancer survivors.

Detailed description

Prostate cancer (PCa) is the most common cancer in men in the U.S. and in other industrialized countries. The lifetime probability of PCa in males is one in nine, and it has a high economic burden, with costs expected to rise. Modern tailored treatment approaches, including androgen deprivation therapy (ADT), have resulted in longer life expectancy, but also longer treatment periods, which lead to significant adverse side effects. These often include decreased bone mineral density (BMD), increased risk of fractures, low functional capacity, loss of lean body mass (LBM), increased fat mass, insulin resistance, psychological distress and pain. Of particular concern is a sharp decline in bone health, with systemic bone loss caused by PCa-produced osteoclastogenic cytokines and drug interventions. Independent of disease stage, fractures in PCa patients are predictors of survival. In addition, concomitant physical inactivity and stress during and after treatment predispose PCa patients to elevated risk of deconditioning, BMD loss, cardiovascular and metabolic disease morbidity and mortality. Exercise-based lifestyle interventions aimed at counteracting treatment-induced adverse effects have been shown to be safe and effective in improving bone, functional and cardiometabolic health for patients with PCa. However, men, in general, are harder to engage in physical activity (PA) and lifestyle interventions. As an alternative to traditional exercise programs, recreational team sports provide a unique environment that may lead to increased physical activity participation and motivation to engage in other lifestyle changes. More than any other sport, recreational soccer (RS) has been shown to be a successful health intervention in patients with, or at risk of chronic diseases, including PCa. Leveraging the growing enthusiasm around soccer in Atlanta and the U.S. may lead to increased interest, participation, retention and engagement in lifestyle change programming among PCa survivors. Therefore, this study seeks to directly test the implementation feasibility of a soccer-based lifestyle change intervention to determine the effect on bone health, body composition, mental health, functional and cardiometabolic status among PCa survivors. Participants will be offered an intensive intervention including RS programming and lifestyle education. The group will receive RS, consisting of conditioning drills and games, adapted to the population during 60-minute sessions twice per week. The researchers will evaluate health outcomes at baseline and after 3 months of the intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSoccer* Soccer drills and other fitness routines (two 1-hour sessions per week) * In person education in Life's Simple 7 to help improve life through Lifestyle changes: smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure.

Timeline

Start date
2019-10-25
Primary completion
2022-07-15
Completion
2022-07-15
First posted
2019-10-30
Last updated
2023-08-22
Results posted
2023-08-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04144127. Inclusion in this directory is not an endorsement.