Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors

Clinicaltrials.gov ID: NCT06500169
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age 55 - 85 Years
b-bullseye-arrow Enrollments 20

Conditions

Localized Prostate Carcinoma, Locally Advanced Prostate Carcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8

Summary

This clinical trial evaluates a golf recreational exercise program for enhancing survivorship in underrepresented prostate cancer survivors. Golf is a multimodal recreational activity that requires participants to utilize all muscle groups to perform the golf swing, walk over hilly and uneven terrain, maintain balance during putting and squat-like tasks. Physical activity and exercise are beneficial to physical function, cognitive function, psychosocial health, and overall quality of life during prostate cancer survivorship. These aspects of health are impacted by prostate cancer treatment, especially androgen deprivation therapy. Additionally, supervised, group-based activity programs facilitate participation in physical activity. Researchers want to examine the changes in functional abilities, psychosocial health, and quality of life following participation in in a golf program designed for prostate cancer survivors.

Detailed Description

PRIMARY OBJECTIVES:

I. To recruit, screen, and enroll prostate cancer survivors. II. To examine the safety, feasibility, and adherence, of the 10-week (wk) GREENS program.

III. To analyze the pre-post intervention data and examine the effects (assessed by Hedges g) of the program on:

IIIa. Physical capacity; IIIb. Psychosocial wellness; IIIc. Health, and; IIId. Cognition.

OUTLINE:

Patients participate in the golf training program composed of group sessions over 1-2 hours with a Professional Golfers’ Association of America (PGA) professional two times per week for ten weeks. Training consists of complimentary/warm up exercises integrated with pelvic floor muscle training, golf instruction, golf practice, and golf play on a Par 3 public golf course. Patients also wear an activity tracker and undergo blood sample collection on the study.

After completion of study intervention, patients are followed up at 6 months.

Locations

2 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • George Salem, PhD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • George Salem, PhD

Eligibility Criteria

Inclusion Criteria:

* First time, primary diagnosis of prostate cancer (PCa)
* Currently receiving androgen deprivation therapy (ADT) and/or androgen receptor blocker) for more than 6 months
* Older adult male: 55-85 years old
* The ability to stand independently without external support
* No or minimal golf experience (played < 5 times in the past 10 years)
* English speaking

Exclusion Criteria:

* Second cancer diagnosis (excluding non-invasive skin cancers) or bone metastases
* Prostatectomy less than 6 months prior to study enrollment (prostatectomy is not a requirement for study entry)
* Symptomatic cardiovascular disease, active angina, uncontrolled hypertension (systolic blood pressure (SBP) > 160 or diastolic blood pressure (DBP) > 90, high resting pulse heart rate (HR) > 90), symptomatic orthostatic hypotension
* Unstable asthma, exacerbated chronic obstructive pulmonary disease (COPD]
* History of injury or orthopedic operation within the last 6 months
* Movement disorders (e.g., Parkinson's disease (PD) or other neurological disorders), hemiparesis or paraparesis
* Severe vision or hearing problems

Study Plan

Supportive care (golf program)

EXPERIMENTAL

Patients participate in the golf training program composed of group sessions over 1-2 hours with a PGA professional two times per week for ten weeks. Training consists of complimentary/warm up exercises integrated with pelvic floor muscle training, golf instruction, golf practice, and golf play on a Par 3 public golf course. Patients also wear an activity tracker and undergo blood sample collection on the study.

  • PROCEDURE:

    Biospecimen Collection

    Description:

    Undergo blood sample collection
  • PROCEDURE:

    Discussion

    Description:

    Ancillary studies
  • OTHER:

    Exercise Intervention

    Description:

    Complete golf related exercises
  • OTHER:

    Interview

    Description:

    Ancillary studies
  • OTHER:

    Medical Device Usage and Evaluation

    Description:

    Wear activity tracker
  • PROCEDURE:

    Physical Examination

    Description:

    Ancillary studies
  • OTHER:

    Physical Performance Testing

    Description:

    Ancillary studies
  • OTHER:

    Questionnaire Administration

    Description:

    Ancillary studies
  • OTHER:

    Recreational Therapy

    Description:

    Participate in golf program

Outcome Measures

Primary Outcome Measures

Enrollment rate

Time Frame: Up to 3 years

Participant adherence to the program

Time Frame: Up to 3 years

Cost of the program

Time Frame: Up to 3 years

Staff adherence

Time Frame: Up to 3 years

Program accommodations

Time Frame: Up to 3 years

Incidence of adverse events

Time Frame: Up to 3 years

Quality of life scores

Time Frame: Up to 3 years

Circulating inflammatory biomarker levels

Time Frame: Up to 3 years

Senior fitness test scores

Time Frame: Up to 3 years

Gait speed

Time Frame: Up to 3 years

Balance Confidence

Time Frame: Up to 3 years

Cognitive function

Time Frame: Up to 3 years

Participant feedback of the program

Time Frame: Up to 3 years

Timeline

  • Last Updated
    July 15, 2024
  • Start Date
    July 15, 2024
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    September 1, 2027

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