N/A
N=3
Soccer Intervention in Prostate Cancer Survivors
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04144127 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Lumbar Spine Bone Mineral Density (BMD) — 1.2; 1.2 mg/cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soccer (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lumbar Spine Bone Mineral Density (BMD) |
1.2; 1.2 | — |
| SECONDARY Total Hip BMD |
1.2; 1.2 | — |
| SECONDARY Osteocalcin Level |
— | — |
| SECONDARY C-terminal Telopeptide of Collagen (CTx) |
— | — |
| SECONDARY Weight |
111.6; 106.6 | — |
| SECONDARY Body Mass Index (BMI) |
34.1; 32.7 | — |
| SECONDARY Percentage of Body Fat |
42.1; 40.9 | — |
| SECONDARY Waist Circumference |
120.6; 117.3 | — |
| SECONDARY Lean Body Mass |
138.9; 135.7 | — |
| SECONDARY Resting Heart Rate |
— | — |
| SECONDARY Systolic Blood Pressure |
140.3; 126.3 | — |
| SECONDARY Diastolic Blood Pressure |
79; 68.3 | — |
| SECONDARY Aerobic Capacity |
536.7; 497.7 | — |
| SECONDARY Muscle Strength |
36.1; 37.7 | — |
| SECONDARY Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Score |
— | — |
| SECONDARY Dietary Intake |
— | — |
| SECONDARY Number of Participants Smoking Cigarettes |
— | — |
| SECONDARY Alcohol Habits |
— | — |
| SECONDARY Sleep Time |
— | — |
| SECONDARY Weekly Steps |
— | — |
| SECONDARY SF-12 Health Survey Score |
44.2; 47.2; 53.2; 53.6 | — |
| SECONDARY Center for Epidemiologic Studies Depression Scale (CESD) Score |
4.3; 5.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- men aged 18-79 years
- PCa survivors that had at least 6 months of hormone therapy (i.e. ADT with testosterone lowering agents) within the past 10 years
- not engaged in soccer practice or other exercise or lifestyle intervention program for the past 12 months
- availability of smartphone to receive text messages
- treating Oncologist clearance
- ability to read in English or Spanish and provide informed consent
Exclusion Criteria
- BMI > 40 kg/m^2
- resting BP ≥170/100 at screening or uncontrolled hypertension
- any mobility issues or exercise program contraindications
- a recent (i.e., within 12 months) myocardial infarction, diagnosis of congestive heart disease, other active cancer
- bone or organ metastases
- chemotherapy within past 6 months
- 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
- not coronavirus disease 2019 (COVID-19) vaccinated
Data sourced from ClinicalTrials.gov (NCT04144127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.