Prostate CancerNCT04144127
Soccer Intervention in Prostate Cancer Survivors
A study testing Soccer in people with Prostate Cancer, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Soccer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2019to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Soccer-based Lifestyle Intervention vs mHealth-based Physical Activity Intervention to Improve Bone Health and Metabolic Health in Prostate Cancer Survivors
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Soccer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoccerBehavioural
Also called Recreational Soccer (RS)
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Soccer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months post-intervention
Secondary outcomes (21)
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.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
Weight
Weight is measured in kilograms (kg).
Measured: Baseline, 3 months post-intervention
Body Mass Index (BMI)
Body Mass Index (BMI) is weight in kilograms divided by the square of height in meters.
Measured: Baseline, 3 months post-intervention
Percentage of Body Fat
Body fat is measured by dual x-ray absorptiometry (DXA) scan.
Measured: Baseline, 3 months post-intervention
Waist Circumference
Waist circumference is measured in centimeters (cm).
Measured: Baseline, 3 months post-intervention
Lean Body Mass
Lean body mass is body weight minus weight from body fat.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
Aerobic Capacity
Aerobic capacity is measured by 6 minute walk test distance (meters).
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
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".
Measured: Baseline, 3 months post-intervention
Alcohol Habits
Number of alcohol beverages per week will be recorded.
Measured: Baseline, 3 months post-intervention
Sleep Time
Average sleep time will be collected in minutes per day.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
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.
Measured: Baseline, 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start25 Oct 2019
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Roberto Felipe Lobelo, Emory University
- Investigators
- Roberto Felipe Lobelo, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144127
- Sponsor's protocol ID
- IRB00110890
- Other IDs
- P30CA138292
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2019
- Last updated
- 22 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Soccer-based Lifestyle Intervention vs mHealth-based Physical Activity Intervention to Improve Bone Health and Metabolic Health in Prostate Cancer Survivors
- ClinicalTrials.gov ID
- NCT04144127
- Acronym / sponsor ID
- IRB00110890
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Posted 22 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soccer Group | Experimental | Behavioral: SoccerParticipants 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoccerAlso: Recreational Soccer (RS)* 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. | Behavioural | Soccer Group |
Primary outcome
Lumbar Spine Bone Mineral Density (BMD)
Time frame: 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.
21 secondary outcomes
Total Hip BMD
Time frame: Baseline, 3 months post-intervention
Osteocalcin Level
Time frame: Baseline, 3 months post-intervention
C-terminal Telopeptide of Collagen (CTx)
Time frame: Baseline, 3 months post-intervention
Weight
Time frame: Baseline, 3 months post-intervention
Body Mass Index (BMI)
Time frame: Baseline, 3 months post-intervention
Percentage of Body Fat
Time frame: Baseline, 3 months post-intervention
Waist Circumference
Time frame: Baseline, 3 months post-intervention
Lean Body Mass
Time frame: Baseline, 3 months post-intervention
Resting Heart Rate
Time frame: Baseline, 3 months post-intervention
Systolic Blood Pressure
Time frame: Baseline, 3 months post-intervention
Diastolic Blood Pressure
Time frame: Baseline, 3 months post-intervention
Aerobic Capacity
Time frame: Baseline, 3 months post-intervention
Muscle Strength
Time frame: Baseline, 3 months post-intervention
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Score
Time frame: Baseline, 3 months post-intervention
Dietary Intake
Time frame: Baseline, 3 months post-intervention
Number of Participants Smoking Cigarettes
Time frame: Baseline, 3 months post-intervention
Alcohol Habits
Time frame: Baseline, 3 months post-intervention
Sleep Time
Time frame: Baseline, 3 months post-intervention
Weekly Steps
Time frame: Baseline, 3 months post-intervention
SF-12 Health Survey Score
Time frame: Baseline, 3 months post-intervention
Center for Epidemiologic Studies Depression Scale (CESD) Score
Time frame: Baseline, 3 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Felipe Lobelo, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soccer in people with Prostate Cancer, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Spine Bone Mineral Density (BMD) (time frame: Baseline, 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.