Clinical trial NCT04144127: Soccer Intervention in Prostate Cancer Survivors
Official title: A Soccer-based Lifestyle Intervention vs mHealth-based Physical Activity Intervention to Improve Bone Health and Metabolic Health in Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-30
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. men aged 18-79 years
2. PCa survivors that had at least 6 months of hormone therapy (i.e. ADT with testosterone lowering agents) within the past 10 years
3. not engaged in soccer practice or other exercise or lifestyle intervention program for the past 12 months
4. availability of smartphone to receive text messages
5. treating Oncologist clearance
6. ability to read in English or Spanish and provide informed consent

Exclusion Criteria:

1. BMI \> 40 kg/m\^2
2. resting BP ≥170/100 at screening or uncontrolled hypertension
3. any mobility issues or exercise program contraindications
4. a recent (i.e., within 12 months) myocardial infarction, diagnosis of congestive heart disease, other active cancer
5. bone or organ metastases
6. chemotherapy within past 6 months
7. therapies and diseases of bone unrelated to PCa e.g. systemic glucocorticoids, bisphosphonates, teriparatide, denosumab, osteomalacia; osteosarcoma; Paget's disease; systemic lupus erythematosus; inflammatory bowel diseases, rheumatoid arthritis; thyroid/parathyroid disorder or mental illness
8. not coronavirus disease 2019 (COVID-19) vaccinated

Primary outcomes:
measure: Lumbar Spine Bone Mineral Density (BMD)
timeFrame: Baseline, 3 months post-intervention
Secondary outcomes:
measure: Total Hip BMD
timeFrame: Baseline, 3 months post-intervention
measure: Osteocalcin Level
timeFrame: Baseline, 3 months post-intervention
measure: C-terminal Telopeptide of Collagen (CTx)
timeFrame: Baseline, 3 months post-intervention
measure: Weight
timeFrame: Baseline, 3 months post-intervention
measure: Body Mass Index (BMI)
timeFrame: Baseline, 3 months post-intervention
measure: Percentage of Body Fat
timeFrame: Baseline, 3 months post-intervention
measure: Waist Circumference
timeFrame: Baseline, 3 months post-intervention
measure: Lean Body Mass
timeFrame: Baseline, 3 months post-intervention
measure: Resting Heart Rate
timeFrame: Baseline, 3 months post-intervention
measure: Systolic Blood Pressure
timeFrame: Baseline, 3 months post-intervention
measure: Diastolic Blood Pressure
timeFrame: Baseline, 3 months post-intervention
measure: Aerobic Capacity
timeFrame: Baseline, 3 months post-intervention
measure: Muscle Strength
timeFrame: Baseline, 3 months post-intervention
measure: Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Score
timeFrame: Baseline, 3 months post-intervention
measure: Dietary Intake
timeFrame: Baseline, 3 months post-intervention
measure: Number of Participants Smoking Cigarettes
timeFrame: Baseline, 3 months post-intervention
measure: Alcohol Habits
timeFrame: Baseline, 3 months post-intervention
measure: Sleep Time
timeFrame: Baseline, 3 months post-intervention
measure: Weekly Steps
timeFrame: Baseline, 3 months post-intervention
measure: SF-12 Health Survey Score
timeFrame: Baseline, 3 months post-intervention
measure: Center for Epidemiologic Studies Depression Scale (CESD) Score
timeFrame: Baseline, 3 months post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Roberto Felipe Lobelo, MD
role: PRINCIPAL_INVESTIGATOR
References: