Cancer
Conditions
Keywords
Cancer Survivor, Physical Activity, Health Outcomes, Rewards-Based Intervention, Cardiovascular Health, Musculoskeletal Health, Exercise
Brief summary
Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity. Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.
Detailed description
PRIMARY OBJECTIVE: * To compare changes in levels of moderate and vigorous physical activity over 24 weeks. SECONDARY OBJECTIVE: * To compare changes in cardiorespiratory fitness, muscular strength and flexibility over 24 weeks. Participants will be randomized to one of three groups. Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. Participants randomized to the two intervention groups will be given access to a rewards program delivered via an interactive website, an activity monitor, and educational materials. Individual physical activity data can be viewed by study participants after uploading information from their monitors to the interactive website. One intervention group will receive minimal rewards, while the other group will receive immediate incentives as well as the minimal rewards as they move from one level to the other on the website. After 24 weeks, changes in cardiorespiratory fitness, muscular strength, flexibility, and physical function will be compared between the two intervention groups and the control group.
Interventions
BEHAVIORALActivity Monitor
Measurement of physical activity.
BEHAVIORALInteractive Website
Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
BEHAVIORALEducational Materials
All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH) * 11 through 14 years of age * Not undergoing active treatment for cancer * Medical clearance from participant's attending physician via email * Does not meet the Centers for Disease Control (CDC) physical activity guidelines. CDC guidelines for children age 11 to 14 are defined as 60 minutes or more per day of physical activity, seven days a week * Internet access and a computer that has software that is compatible with the study device (Windows XP, Windows Vista, Windows 7, Mac OSX 10.5 and Mac OSX 10.6)
Exclusion criteria
* Global cognitive impairment (Full Scale Intelligence Quotient \< 70) that prevents use of the interactive website * Pregnant female * Inability to read and write English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups | Baseline, Week 24 | The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach | Baseline and 24 weeks | The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups |
| Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion | Baseline and 24 weeks | The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups. |
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip | Baseline and 24 weeks | The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups. |
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up | Baseline and 24 weeks | The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups. |
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup | Baseline and 24 weeks | The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups. |
| Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks | Baseline and 24 weeks | The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups. |
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second | Baseline and 24 weeks | The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups. |
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second | Baseline and 24 weeks | The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups |
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second | Baseline and 24 weeks | The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups. |
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second | Baseline and 24 weeks | The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups. |
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second | Baseline and 24 weeks | The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups. |
Countries
United States
Participant flow
Recruitment details
This protocol enrolled 105 participants at St. Jude Children's Research Hospital from 9/2013 through 4/2014. Of the 105, 5 were determined to be ineligible after baseline screening (4 too active; 1 did not meet IQ criteria), and 2 withdrew prior to randomization but after baseline testing. The remaining 98 were randomized.
Pre-assignment details
98 participants were randomized 1:1:1 stratified by gender into 3 groups. Randomization was implemented using software based on Zelen's methodology. The principal investigator and study staff were blind to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Group A: Minimal Rewards Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance. | 25 |
| Group B: Immediate Incentives Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance. | 31 |
| Group C: Control Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance. | 26 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 4 |
Baseline characteristics
| Characteristic | Group A: Minimal Rewards | Total | Group C: Control | Group B: Immediate Incentives |
|---|---|---|---|---|
| Active dorsiflexion | 13.1 degrees STANDARD_DEVIATION 7.6 | 13.7 degrees STANDARD_DEVIATION 8.1 | 14.3 degrees STANDARD_DEVIATION 8.6 | 13.6 degrees STANDARD_DEVIATION 8.1 |
| Age, Continuous | 13.0 years STANDARD_DEVIATION 1.2 | 12.8 years STANDARD_DEVIATION 1.1 | 12.6 years STANDARD_DEVIATION 1.2 | 12.8 years STANDARD_DEVIATION 0.9 |
| Age, Customized Age at diagnosis | 3.0 years STANDARD_DEVIATION 3.1 | 3.6 years STANDARD_DEVIATION 2.9 | 3.6 years STANDARD_DEVIATION 2.5 | 4.2 years STANDARD_DEVIATION 3 |
| Age, Customized Time since diagnosis | 10.0 years STANDARD_DEVIATION 3 | 9.2 years STANDARD_DEVIATION 2.9 | 9.0 years STANDARD_DEVIATION 2.7 | 8.6 years STANDARD_DEVIATION 3.1 |
| Blood pressure (BP) Diastolic | 68.2 mmHG STANDARD_DEVIATION 7.3 | 67.5 mmHG STANDARD_DEVIATION 7.9 | 68.5 mmHG STANDARD_DEVIATION 9.3 | 66.2 mmHG STANDARD_DEVIATION 7.2 |
| Blood pressure (BP) Systolic | 115.6 mmHG STANDARD_DEVIATION 9.8 | 115.4 mmHG STANDARD_DEVIATION 10.3 | 117.6 mmHG STANDARD_DEVIATION 11.2 | 113.5 mmHG STANDARD_DEVIATION 9.9 |
| Body mass index (BMI) | 25.0 kg/m^2 STANDARD_DEVIATION 6.6 | 23.4 kg/m^2 STANDARD_DEVIATION 6.1 | 22.8 kg/m^2 STANDARD_DEVIATION 5.5 | 22.6 kg/m^2 STANDARD_DEVIATION 6.3 |
| Daily Moderate to Vigorous Physical Activity (MVPA) | 26.8 minutes STANDARD_DEVIATION 15.7 | 29.0 minutes STANDARD_DEVIATION 18.2 | 32.3 minutes STANDARD_DEVIATION 22.6 | 28.0 minutes STANDARD_DEVIATION 16.6 |
| Diagnosis Central Nervous System Tumor | 7 participants | 18 participants | 4 participants | 7 participants |
| Diagnosis Leukemia | 5 participants | 19 participants | 7 participants | 7 participants |
| Diagnosis Lymphoma | 2 participants | 8 participants | 4 participants | 2 participants |
| Diagnosis Other Solid Tumor | 5 participants | 24 participants | 9 participants | 10 participants |
| Diagnosis Retinoblastoma | 6 participants | 13 participants | 2 participants | 5 participants |
| Dorsiflexion at 30 degrees/second | 21.7 Nm/kg STANDARD_DEVIATION 8.7 | 25.5 Nm/kg STANDARD_DEVIATION 13 | 27.9 Nm/kg STANDARD_DEVIATION 15 | 26.5 Nm/kg STANDARD_DEVIATION 14.9 |
| Dorsiflexion at 60 degrees/second | 19.9 Nm/kg STANDARD_DEVIATION 7.4 | 23.5 Nm/kg STANDARD_DEVIATION 10.3 | 25.5 Nm/kg STANDARD_DEVIATION 11.1 | 24.7 Nm/kg STANDARD_DEVIATION 12 |
| Hand grip | 20.9 kg STANDARD_DEVIATION 6.3 | 20.7 kg STANDARD_DEVIATION 6.3 | 22.5 kg STANDARD_DEVIATION 7.1 | 19.0 kg STANDARD_DEVIATION 5.6 |
| Peak VO2 | 30.0 ml/kg/min STANDARD_DEVIATION 7.9 | 30.4 ml/kg/min STANDARD_DEVIATION 7.5 | 31.2 ml/kg/min STANDARD_DEVIATION 6.6 | 30.0 ml/kg/min STANDARD_DEVIATION 7.8 |
| Pushup | 9.6 push-ups STANDARD_DEVIATION 6.6 | 11.9 push-ups STANDARD_DEVIATION 6.6 | 12.4 push-ups STANDARD_DEVIATION 7.5 | 13.3 push-ups STANDARD_DEVIATION 5.9 |
| Quadriceps at 120 degrees/second | 136.5 Newton meters (Nm)/kg STANDARD_DEVIATION 36.2 | 139.0 Newton meters (Nm)/kg STANDARD_DEVIATION 38.4 | 137.8 Newton meters (Nm)/kg STANDARD_DEVIATION 36.5 | 142.0 Newton meters (Nm)/kg STANDARD_DEVIATION 41.7 |
| Quadriceps at 180 degrees/second | 117.6 Newton meters (Nm)/kg STANDARD_DEVIATION 32.9 | 119.4 Newton meters (Nm)/kg STANDARD_DEVIATION 33.3 | 118.6 Newton meters (Nm)/kg STANDARD_DEVIATION 29.5 | 121.7 Newton meters (Nm)/kg STANDARD_DEVIATION 36.7 |
| Quadriceps at 60 degrees/second | 156.3 Newton meters (Nm)/kg STANDARD_DEVIATION 46 | 160.4 Newton meters (Nm)/kg STANDARD_DEVIATION 44.5 | 159.9 Newton meters (Nm)/kg STANDARD_DEVIATION 41 | 164.2 Newton meters (Nm)/kg STANDARD_DEVIATION 46.3 |
| Race/Ethnicity, Customized Non-White | 3 participants | 17 participants | 8 participants | 6 participants |
| Race/Ethnicity, Customized White | 22 participants | 65 participants | 18 participants | 25 participants |
| Resting heart rate (HR) | 82.8 beats/minute STANDARD_DEVIATION 11.2 | 81.5 beats/minute STANDARD_DEVIATION 13.6 | 81.5 beats/minute STANDARD_DEVIATION 14.9 | 80.4 beats/minute STANDARD_DEVIATION 14.5 |
| Resting respiratory rate (RR) | 19.2 breaths/minute STANDARD_DEVIATION 1.1 | 18.9 breaths/minute STANDARD_DEVIATION 1.4 | 18.4 breaths/minute STANDARD_DEVIATION 1.7 | 19.0 breaths/minute STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 14 Participants | 44 Participants | 14 Participants | 16 Participants |
| Sex: Female, Male Male | 11 Participants | 38 Participants | 12 Participants | 15 Participants |
| Sit and reach | 21.7 cm STANDARD_DEVIATION 8.9 | 21.1 cm STANDARD_DEVIATION 9.7 | 22.2 cm STANDARD_DEVIATION 10.4 | 19.6 cm STANDARD_DEVIATION 9.8 |
| Sit-up | 14.3 sit-ups STANDARD_DEVIATION 5.1 | 15.2 sit-ups STANDARD_DEVIATION 5.8 | 16.2 sit-ups STANDARD_DEVIATION 6.2 | 15.2 sit-ups STANDARD_DEVIATION 6.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 25 | 0 / 31 | 0 / 26 |
| serious Total, serious adverse events | 0 / 25 | 0 / 31 | 0 / 26 |
Outcome results
Primary
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.
Time frame: Baseline, Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups | -2.58 minutes | Standard Deviation 13.7 |
| Group B: Immediate Incentives | Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups | -2.12 minutes | Standard Deviation 12.95 |
| Group C: Control | Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups | -7.78 minutes | Standard Deviation 13.7 |
p-value: 0.9t-test, 2 sided
p-value: 0.18t-test, 2 sided
p-value: 0.14t-test, 2 sided
Secondary
Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks
The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks | -0.21 ml/kg/min | Standard Deviation 5.15 |
| Group B: Immediate Incentives | Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks | -1.19 ml/kg/min | Standard Deviation 4.7 |
| Group C: Control | Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks | 0.09 ml/kg/min | Standard Deviation 5.25 |
p-value: 0.49t-test, 2 sided
p-value: 0.84t-test, 2 sided
p-value: 0.37t-test, 2 sided
Secondary
Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion
The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion | -1.72 degrees | Standard Deviation 6.4 |
| Group B: Immediate Incentives | Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion | -0.55 degrees | Standard Deviation 5.7 |
| Group C: Control | Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion | -0.32 degrees | Standard Deviation 6.25 |
p-value: 0.49t-test, 2 sided
p-value: 0.43t-test, 2 sided
p-value: 0.89t-test, 2 sided
Secondary
Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach
The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach | -0.71 cm | Standard Deviation 4.85 |
| Group B: Immediate Incentives | Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach | 2.25 cm | Standard Deviation 4.5 |
| Group C: Control | Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach | -0.02 cm | Standard Deviation 4.85 |
p-value: 0.03t-test, 2 sided
p-value: 0.63t-test, 2 sided
p-value: 0.09t-test, 2 sided
Secondary
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second
The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second | 3.94 Nm/kg | Standard Deviation 16.25 |
| Group B: Immediate Incentives | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second | -3.74 Nm/kg | Standard Deviation 14.75 |
| Group C: Control | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second | -2.81 Nm/kg | Standard Deviation 16.65 |
p-value: 0.08t-test, 2 sided
p-value: 0.15t-test, 2 sided
p-value: 0.83t-test, 2 sided
Secondary
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second
The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second | 3.82 Nm/kg | Standard Deviation 12.85 |
| Group B: Immediate Incentives | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second | -3.00 Nm/kg | Standard Deviation 11.65 |
| Group C: Control | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second | -2.14 Nm/kg | Standard Deviation 13.15 |
p-value: 0.05t-test, 2 sided
p-value: 0.11t-test, 2 sided
p-value: 0.81t-test, 2 sided
Secondary
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip
The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip | 1.47 kg | Standard Deviation 3.5 |
| Group B: Immediate Incentives | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip | 0.98 kg | Standard Deviation 3.2 |
| Group C: Control | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip | 1.00 kg | Standard Deviation 3.45 |
p-value: 0.61t-test, 2 sided
p-value: 0.64t-test, 2 sided
p-value: 0.99t-test, 2 sided
Secondary
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup
The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup | 2.37 Pushups | Standard Deviation 5.7 |
| Group B: Immediate Incentives | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup | 1.93 Pushups | Standard Deviation 5.4 |
| Group C: Control | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup | 2.27 Pushups | Standard Deviation 5.95 |
p-value: 0.78t-test, 2 sided
p-value: 0.95t-test, 2 sided
p-value: 0.83t-test, 2 sided
Secondary
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second
The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second | -6.62 Nm/kg | Standard Deviation 28.95 |
| Group B: Immediate Incentives | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second | -0.59 Nm/kg | Standard Deviation 25.7 |
| Group C: Control | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second | 4.16 Nm/kg | Standard Deviation 28.35 |
p-value: 0.44t-test, 2 sided
p-value: 0.19t-test, 2 sided
p-value: 0.54t-test, 2 sided
Secondary
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second
The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second | -0.64 Nm/kg | Standard Deviation 28.1 |
| Group B: Immediate Incentives | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second | 0.78 Nm/kg | Standard Deviation 25.5 |
| Group C: Control | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second | 2.55 Nm/kg | Standard Deviation 28.1 |
p-value: 0.17t-test, 2 sided
p-value: 0.13t-test, 2 sided
p-value: 0.81t-test, 2 sided
Secondary
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second
The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second | -4.10 Newton meters (Nm)/kg | Standard Deviation 34.8 |
| Group B: Immediate Incentives | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second | -2.05 Newton meters (Nm)/kg | Standard Deviation 31.55 |
| Group C: Control | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second | -1.91 Newton meters (Nm)/kg | Standard Deviation 34.8 |
p-value: 0.83t-test, 2 sided
p-value: 0.83t-test, 2 sided
p-value: 0.99t-test, 2 sided
Secondary
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up
The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Minimal Rewards | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up | 2.67 Sit-ups | Standard Deviation 5.65 |
| Group B: Immediate Incentives | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up | 3.29 Sit-ups | Standard Deviation 5.25 |
| Group C: Control | Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up | 2.43 Sit-ups | Standard Deviation 5.8 |
p-value: 0.69t-test, 2 sided
p-value: 0.89t-test, 2 sided
p-value: 0.59t-test, 2 sided