Clinical trial · Interventional
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
NCT04144127CI-TRIAL-00068993completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Soccer | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Soccer Group
- description
- Participants in the soccer group will participate in soccer drills and other fitness routines (two 1-hour sessions per week). They will meet with the soccer coach after the soccer sessions to discuss the lifestyle education topics (Life's Simple 7 education topics). During the soccer sessions participants will be fitted with a wearable soccer-specific device to measure how much they move and their heart rate. All participants will receive a Garmin Vivofit wearable device to help monitor their PA goals and achievements.
- interventionNames
- Behavioral: Soccer
Primary outcomes (1)
- measure
- Lumbar Spine Bone Mineral Density (BMD)
- timeFrame
- Baseline, 3 months post-intervention
- description
- Bone mineral density will be measured by dual x-ray absorptiometry (DXA) scan at the lumbar spine (L2-L4). Decreased BMD a is associated with an increased risk of fractures.
Secondary outcomes (21)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.