Physical Activity Clinical Trial
— KAMOfficial title:
KAM: Kids Are Moving; An Exercise Program for Children With Cancer
Verified date | May 2017 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
During cancer treatment children are less active than their health peers. This inactivity
persists into survivorship and can negatively affect health and quality of life. Physical
activity may also improve fatigue, a prevalent and distressing symptom during treatment.
Improving health behaviors during treatment can have lifelong benefits for cancer survivors.
In this study, the effectiveness of the "Kids are Moving" exercise program will be
evaluated. The exercise program will follow program guidelines set up by the American
College of Sports Medicine and will be adapted for children with cancer. Children ages 6 to
18 years, who are receiving chemotherapy, and their parents, will be coached on how to
increase their physical activity and will receive an exercise prescription. This will occur
as part of the standard care they receive from the nurse practitioners during the first six
months of their outpatient visits. Investigators want to find out if children in the Kids
are Moving program are more active and have less fatigue. Activity will be measured through
patient questionnaires about activity and fatigue, and by wearing the FitBit activity
tracker and an actigraph. Outcomes will be compared to measurements collected from children
who received usual care before the exercise program started.
Physical activity is a vital for improving health and quality of life and for providing
energy for engaging in positive life experiences as children move along the developmental
continuum to a long and healthy future. Outcomes of the study will provide a foundation for
larger multi-site clinical trials.
Status | Completed |
Enrollment | 31 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility |
Inclusion Criteria: 1. between the ages of 6 and 18 with any cancer diagnosis except for bone tumors or have bone metastasis 2. have received cancer treatment that includes chemotherapy for at least 2 months, have outpatient visits at least once a month, and are ambulatory 3. speak English 4. are able to give assent according to institutional guidelines 5. have parental consent to participate. Exclusion Criteria: 1. Not meeting inclusion criteria |
Country | Name | City | State |
---|---|---|---|
United States | Children's Minnesota | Minneapolis | Minnesota |
United States | University of Minnesota Masonic Childrens | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical activity measured by FitBit Flex | Change from Baseline, at 2 month, at 4, months, at 6 months | ||
Secondary | Self-report of fatigue | Change from Baseline, at 2 month, at 4, months, at 6 months |
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