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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04144127

Enrollment

Registered

2019-10-30

Start date

2019-10-25

Completion date

2022-07-15

Last updated

2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Detailed 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.

Interventions

BEHAVIORALSoccer

* 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Lumbar Spine Bone Mineral Density (BMD)	Baseline, 3 months post-intervention	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

Measure	Time frame	Description
Osteocalcin Level	Baseline, 3 months post-intervention	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.
C-terminal Telopeptide of Collagen (CTx)	Baseline, 3 months post-intervention	C-terminal telopeptide of collagen (CTx) is a bone resorption marker. Increased levels indicate increased bone resorption with conditions such as osteoporosis and osteopenia.
Weight	Baseline, 3 months post-intervention	Weight is measured in kilograms (kg).
Body Mass Index (BMI)	Baseline, 3 months post-intervention	Body Mass Index (BMI) is weight in kilograms divided by the square of height in meters.
Percentage of Body Fat	Baseline, 3 months post-intervention	Body fat is measured by dual x-ray absorptiometry (DXA) scan.
Waist Circumference	Baseline, 3 months post-intervention	Waist circumference is measured in centimeters (cm).
Lean Body Mass	Baseline, 3 months post-intervention	Lean body mass is body weight minus weight from body fat.
Resting Heart Rate	Baseline, 3 months post-intervention	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.
Systolic Blood Pressure	Baseline, 3 months post-intervention	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.
Diastolic Blood Pressure	Baseline, 3 months post-intervention	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.
Total Hip BMD	Baseline, 3 months post-intervention	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.
Muscle Strength	Baseline, 3 months post-intervention	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.
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Score	Baseline, 3 months post-intervention	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.
Dietary Intake	Baseline, 3 months post-intervention	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.
Number of Participants Smoking Cigarettes	Baseline, 3 months post-intervention	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.
Alcohol Habits	Baseline, 3 months post-intervention	Number of alcohol beverages per week will be recorded.
Sleep Time	Baseline, 3 months post-intervention	Average sleep time will be collected in minutes per day.
Weekly Steps	Baseline, 3 months post-intervention	Participants will be asked to wear a Garmin fitness tracker throughout the study and physical activity will be measured as steps taken per week.
SF-12 Health Survey Score	Baseline, 3 months post-intervention	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.
Center for Epidemiologic Studies Depression Scale (CESD) Score	Baseline, 3 months post-intervention	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.
Aerobic Capacity	Baseline, 3 months post-intervention	Aerobic capacity is measured by 6 minute walk test distance (meters).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Soccer Group 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. 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.	3
Total	3

Arm

Count

Soccer Group

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. 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.

Total

Baseline characteristics

Characteristic	Soccer Group
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	3 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	3 Participants
Region of Enrollment United States	3 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 3
other Total, other adverse events	0 / 3
serious Total, serious adverse events	0 / 3

Outcome results

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.