Clinical trial NCT00686283: Personalized Exercise for Adolescents With Diabetes
Official title: Personalized Exercise for Adolescents With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: Adolescents
Diabetes
Exercise
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 39
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to determine the likely benefits of a study that would use the novel techniques both of writing an exercise "prescription" and of including the family and/or community in sticking to the exercise prescription by youths with diabetes, who often suffer eventual cardiovascular complications that might be lessened by the exercise.

Detailed description: Diabetes mellitus (DM) is now the sixth leading cause of death in the U.S., primarily due to cardiovascular (CV) complications. People with DM have a 2 to 4 times increased risk for heart disease. An increasing number of adolescents are diagnosed with DM, predisposing them to CV morbidity and mortality in early adulthood. Using a comparison group pretest-posttest design, the Primary Aim of this investigation is to determine the feasibility of conducting a novel personalized exercise prescription (PEP) intervention with 20 adolescents who have type 1 DM and 20 adolescents with type 2 DM. We will explore the influence of DM-specific family social support, exercise self-efficacy, and benefits and barriers to exercise on adherence to PEP. The Secondary Aim is to explore possible changes in physiological (i.e., cardiorespiratory fitness, heart rate variability, metabolic control, and lipid profile) and psychological outcomes (i.e., diabetes quality of life \[QOL\]) of the PEP intervention in adolescents with type 1 or type 2 DM. Long-term benefits of exercise for persons with DM include decreased risk factors for CV disease, improved well-being, and increased life expectancy. The current decline in physical activity during adolescence is problematic, particularly for those with DM, who have an added risk for future CV disease. The limited research available on the efficacy of exercise interventions with youths who have type 1 DM indicates improvements in cardiorespiratory fitness, lipid profile, and glucose regulation. No published exercise intervention research with adolescents who have type 2 DM is available. However, exercise interventions with overweight youth have shown increased heart rate variability and cardiorespiratory fitness. Although numerous studies have examined various school-based strategies to promote more physically active lives in youth populations, no studies have examined the feasibility of conducting individualized, culturally focused exercise prescriptions for adolescents with type 1 or type 2 DM that incorporate family support in a home or community setting. Nor have studies addressed the possible psychosocial and physiological outcomes of these personalized approaches. This investigation will extend the principal investigator's program of research that identified differences in CV risks for adolescents with type 1 vs. type 2 DM. Determining factors that influence the conduct and outcomes of individualized exercise interventions for adolescents with DM can potentially lead to the development of programs that promote adherence to exercise, avert complications, and improve QOL and overall health.

Eligibility criteria: Inclusion Criteria:

* Adolescents aged 12 to 19
* With a diagnosis of type 1 or type 2 DM
* Score on Physical Activity Recall (PAR) Scale of 36 metabolic equivalents (METs) or less to ensure enrollment of youths who are not already engaged in a regular exercise or sports program
* Have a parent (guardian) who also agrees to attend personalized exercise program (PEP) training, participate in exercising and provide ongoing encouragement and support for PEP, and who does not have any positive responses to the Physical Activity Readiness Questionnaire (PAR-Q). The decision to use a value for METs \< 36 is based upon current PAR data from the PI's R01 that revealed a mean score of 34.7 ± 3.1 for teens with type 1 DM and 33.5 ± 1.4 for teens with type 2 DM. Mean scores for both groups reflect activity levels that are well below the current recommendation of 60 minutes of moderate to vigorous exercise on most days of the week.

Exclusion criteria:

Subjects will be excluded if they:

* Are in a school grade that is not appropriate to age within 2 years (this is to control for overt delays in cognition, literacy, and psychological or behavioral functioning)
* Have developed diabetes as a secondary condition to treatment for another chronic condition (i.e., cancer)
* Have known cardiac defects
* Are pregnant females.

Primary outcomes:
measure: exercise adherence
timeFrame: Longitudinal and following the 16-week intervention
Secondary outcomes:
measure: cardiorespiratory fitness
timeFrame: Following the 16-week intervention
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
Study officials:
References:
citation: Michaliszyn SF, Higgins M, Faulkner MS. Patterns of Physical Activity Adherence by Adolescents With Diabetes or Obesity Enrolled in a Personalized Community-Based Intervention. Diabetes Educ. 2018 Dec;44(6):519-530. doi: 10.1177/0145721718805693. Epub 2018 Oct 11.
citation: Faulkner MS, Michaliszyn SF, Hepworth JT, Wheeler MD. Personalized exercise for adolescents with diabetes or obesity. Biol Res Nurs. 2014 Jan;16(1):46-54. doi: 10.1177/1099800413500064. Epub 2013 Aug 20.
citation: Michaliszyn SF, Faulkner MS. Physical activity and sedentary behavior in adolescents with type 1 diabetes. Res Nurs Health. 2010 Oct;33(5):441-9. doi: 10.1002/nur.20393.