Trial Outcomes & Findings for Soccer Intervention in Prostate Cancer Survivors (NCT NCT04144127)
NCT ID: NCT04144127
Last Updated: 2023-08-22
Results Overview
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.
COMPLETED
NA
3 participants
Baseline, 3 months post-intervention
2023-08-22
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
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3
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Soccer Intervention in Prostate Cancer Survivors
Baseline characteristics by cohort
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
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Age, Categorical
>=65 years
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3 Participants
n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Region of Enrollment
United States
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3 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, 3 months post-interventionBone 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.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Lumbar Spine Bone Mineral Density (BMD)
Baseline
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1.2 mg/cm^3
Standard Deviation 0.3
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Lumbar Spine Bone Mineral Density (BMD)
3 months post-intervention
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1.2 mg/cm^3
Standard Deviation 0.3
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionBone 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.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Total Hip BMD
Baseline
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1.2 mg/cm^3
Standard Deviation 0.1
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Total Hip BMD
3 months post-intervention
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1.2 mg/cm^3
Standard Deviation 0.1
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Unable to collect sample for this study outcome.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Unable to collect information for this study outcome.
C-terminal telopeptide of collagen (CTx) is a bone resorption marker. Increased levels indicate increased bone resorption with conditions such as osteoporosis and osteopenia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionWeight is measured in kilograms (kg).
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Weight
Baseline
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111.6 Kg
Standard Deviation 10.4
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Weight
3 months post-intervention
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106.6 Kg
Standard Deviation 11.1
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionBody Mass Index (BMI) is weight in kilograms divided by the square of height in meters.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Body Mass Index (BMI)
Baseline
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34.1 kg/m^2
Standard Deviation 1.7
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Body Mass Index (BMI)
3 months post-intervention
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32.7 kg/m^2
Standard Deviation 2.0
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionBody fat is measured by dual x-ray absorptiometry (DXA) scan.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Percentage of Body Fat
Baseline
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42.1 % of body fat
Standard Deviation 3.3
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Percentage of Body Fat
3 months post-intervention
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40.9 % of body fat
Standard Deviation 2.9
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionWaist circumference is measured in centimeters (cm).
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Waist Circumference
Baseline
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120.6 cms
Standard Deviation 0.5
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Waist Circumference
3 months post-intervention
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117.3 cms
Standard Deviation 0.5
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionLean body mass is body weight minus weight from body fat.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Lean Body Mass
Baseline
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138.9 lbs
Standard Deviation 16.9
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Lean Body Mass
3 months post-intervention
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135.7 lbs
Standard Deviation 17.9
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Information was not collected for this outcome.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionSystolic 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.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Systolic Blood Pressure
Baseline
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140.3 mmHg
Standard Deviation 15.9
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Systolic Blood Pressure
3 months post-intervention
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126.3 mmHg
Standard Deviation 22.3
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionDiastolic 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.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Diastolic Blood Pressure
Baseline
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79 mmHg
Standard Deviation 12.5
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Diastolic Blood Pressure
3 months post-intervention
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68.3 mmHg
Standard Deviation 11.9
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionAerobic capacity is measured by 6 minute walk test distance (meters).
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Aerobic Capacity
Baseline
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536.7 meters
Standard Deviation 80.8
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Aerobic Capacity
3 months post-intervention
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497.7 meters
Standard Deviation 54.1
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionMuscle 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.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Muscle Strength
Baseline
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36.1 Kg
Standard Deviation 4.3
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Muscle Strength
3 months post-intervention
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37.7 Kg
Standard Deviation 4.4
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Information was not collected for this study outcome.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Information was not collected for this study outcome.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Information was not collected for this study outcome.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Information for this outcome was not collected.
Number of alcohol beverages per week will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Information was not collected for this study outcome.
Average sleep time will be collected in minutes per day.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionPopulation: Information was not collected for this study outcome.
Participants will be asked to wear a Garmin fitness tracker throughout the study and physical activity will be measured as steps taken per week.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionQuality 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.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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SF-12 Health Survey Score
Baseline PCS
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44.2 score on a scale
Standard Deviation 17.4
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SF-12 Health Survey Score
3 months post-intervention PCS
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47.2 score on a scale
Standard Deviation 9.5
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SF-12 Health Survey Score
Baseline MCS
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53.2 score on a scale
Standard Deviation 8.7
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SF-12 Health Survey Score
3 months post-intervention MCS
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53.6 score on a scale
Standard Deviation 4.9
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SECONDARY outcome
Timeframe: Baseline, 3 months post-interventionSymptoms 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.
Outcome measures
| Measure |
Soccer Group
n=3 Participants
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.
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|---|---|
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Center for Epidemiologic Studies Depression Scale (CESD) Score
Baseline
|
4.3 score on a scale
Standard Deviation 5.9
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Center for Epidemiologic Studies Depression Scale (CESD) Score
3 months post-intervention
|
5.3 score on a scale
Standard Deviation 5.9
|
Adverse Events
Soccer Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place