Soccer Intervention in Prostate Cancer Survivors

Prostate Cancer Clinical Trial

Official title:

A Soccer-based Lifestyle Intervention vs mHealth-based Physical Activity Intervention to Improve Bone Health and Metabolic Health in Prostate Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144127
• Other study ID #: IRB00110890
• Secondary ID: P30CA138292
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: July 15, 2022

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Soccer
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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Hip BMD	Bone mineral density will be measured by dual x-ray absorptiometry (DXA) scan at the hip. Decreased BMD a is associated with an increased risk of fractures.	Baseline, 3 months post-intervention
Secondary	Osteocalcin Level	Osteocalcin is marker of bone formation. The normal range for osteocalcin varies by lab and elevated levels are seen in patients with bone diseases characterized by increased bone turnover.	Baseline, 3 months post-intervention
Secondary	C-terminal Telopeptide of Collagen (CTx)	C-terminal telopeptide of collagen (CTx) is a bone resorption marker. Increased levels indicate increased bone resorption with conditions such as osteoporosis and osteopenia.	Baseline, 3 months post-intervention
Secondary	Weight	Weight is measured in kilograms (kg).	Baseline, 3 months post-intervention
Secondary	Body Mass Index (BMI)	Body Mass Index (BMI) is weight in kilograms divided by the square of height in meters.	Baseline, 3 months post-intervention
Secondary	Percentage of Body Fat	Body fat is measured by dual x-ray absorptiometry (DXA) scan.	Baseline, 3 months post-intervention
Secondary	Waist Circumference	Waist circumference is measured in centimeters (cm).	Baseline, 3 months post-intervention
Secondary	Lean Body Mass	Lean body mass is body weight minus weight from body fat.	Baseline, 3 months post-intervention
Secondary	Resting Heart Rate	The normal resting heart rate in adults is between 60 and 100 beats per minute (bpm). A lower resting heart rate indicates that the person has better fitness as the heart is working more efficiently.	Baseline, 3 months post-intervention
Secondary	Systolic Blood Pressure	Systolic blood pressure (BP) will be measured while sitting using a calibrated electronic blood pressure sphygmomanometer at Baseline and at 3 months post-intervention. A normal systolic blood pressure reading is lower than 120 mmHg. BP values higher than 120 mmHg correlate with worse outcome.	Baseline, 3 months post-intervention
Secondary	Diastolic Blood Pressure	Diastolic blood pressure (BP) will be measured while sitting using a calibrated electronic blood pressure sphygmomanometer prior to any activity (Baseline) and at 3 months post-intervention. A normal diastolic blood pressure reading is lower than 80 mmHg. BP values higher than 80 mmHg correlate with worse outcome.	Baseline, 3 months post-intervention
Secondary	Aerobic Capacity	Aerobic capacity is measured by 6 minute walk test distance (meters).	Baseline, 3 months post-intervention
Secondary	Muscle Strength	Muscle strength is measured as hand grip strength (kg). Hand grip was measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles of the dominant hand. An increase in values means that grip strength is improving.	Baseline, 3 months post-intervention
Secondary	Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Score	Physical activity self-efficacy is assessed with the BREQ-2 instrument. The BREQ-2 has 19 items measuring motivation to exercise, with 5 motivational styles examined: intrinsic regulation (the respondent finds physical activity enjoyable), identified regulation (the respondent sees benefits of physical activity), introjected regulation (physical activity is done to increase self-esteem or avoid negative feelings with not performing exercise), external regulation (physical activity is done based on rewards or punishments from someone else), and amotivation (the respondent has no motivation to engage in physical activity). Responses are given on a 5 point Likert scale where 0=not true for me, and 4=very true for me. A relative autonomy index (RAI) can be calculated by weighting the scores for each motivational style factor. The weights range from 3 to -3 and total RAI scores range from -24 to 20. Higher scores indicate greater self-determined motivation to engage in physical activity.	Baseline, 3 months post-intervention
Secondary	Dietary Intake	The dietary intake is measured using the Nutrition Database System for Research (NDSR) 24-hour dietary recall. The NDSR is a dietary analysis software application used to collect and calculate nutritional intake.	Baseline, 3 months post-intervention
Secondary	Number of Participants Smoking Cigarettes	Smoking habits are assessed with the National Health and Nutrition Examination Survey (NHANES) 2019-2020 for smoking and tobacco use. This instrument includes 24 items and the number of questions that a respondent answers depends on their past and current smoking behaviors. Participants are asked if they currently smoke cigarettes and possible responses are: "every day", "some days", and "not at all".	Baseline, 3 months post-intervention
Secondary	Alcohol Habits	Number of alcohol beverages per week will be recorded.	Baseline, 3 months post-intervention
Secondary	Sleep Time	Average sleep time will be collected in minutes per day.	Baseline, 3 months post-intervention
Secondary	Weekly Steps	Participants will be asked to wear a Garmin fitness tracker throughout the study and physical activity will be measured as steps taken per week.	Baseline, 3 months post-intervention
Secondary	SF-12 Health Survey Score	Quality of life is assessed with the SF-12 Health Survey. The SF-12 is a multipurpose, standardized self-report short form survey with 12 questions assessing mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.	Baseline, 3 months post-intervention
Secondary	Center for Epidemiologic Studies Depression Scale (CESD) Score	Symptoms of depression are assessed with the CESD. The CESD is a 20-item questionnaire asking about feelings and behaviors during the past week. Responses are given on a 4-point scale where 0 = rarely or none of the time (less than 1 day), 1 = some or a little of the time (1-2 days), 2 = occasionally or a moderate amount of time (3-4 days), and 3 = most or all of the time (5-7 days). Scores range from 0 to 60 with high scores indicating greater depressive symptoms.	Baseline, 3 months post-intervention