Soccer Intervention in Prostate Cancer Survivors

NCT04144127 | Completed Results

• 2 other identifiers: IRB00110890P30CA138292
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Lumbar Spine Bone Mineral Density (BMD)

  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.

  Baseline, 3 months post-intervention

Secondary Outcomes (21)

• Total Hip BMD

  Baseline, 3 months post-intervention

• Osteocalcin Level

  Baseline, 3 months post-intervention

• C-terminal Telopeptide of Collagen (CTx)

  Baseline, 3 months post-intervention

• Weight

  Baseline, 3 months post-intervention

• Body Mass Index (BMI)

  Baseline, 3 months post-intervention

Study Arms (1)

Soccer Group

EXPERIMENTAL

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.

Behavioral: Soccer

Interventions

Soccer BEHAVIORAL

* 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.

Also known as: Recreational Soccer (RS)

Soccer Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Felipe Lobelo
• Organization: Emory University

felipelobelo@emory.edu

(770) 488-5737

Study Officials

• Roberto Felipe Lobelo, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: October 25, 2019
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: August 22, 2023
• Results First Posted: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)