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Personalized Exercise for Adolescents With Diabetes

Personalized Exercise for Adolescents With Diabetes

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00686283
Enrollment
39
Registered
2008-05-29
Start date
2007-08-31
Completion date
2010-07-31
Last updated
2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Adolescents, Diabetes, Exercise

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.

Interventions

BEHAVIORALPEP intervention

This study will explore the feasibility of adherence to a personalized exercise prescription (PEP) in adolescents with type 1 or type 2 diabetes. The PEP intervention consists of a 2-hour group education session and a 16-week personalized exercise plan implemented in the home or community setting with the use of parental support and care ambassadors. Care ambassadors will maintain consistency of interactions with specific families for the duration of the PEP intervention. This consistency will aid in establishing rapport with the adolescents and parents to answer any questions and provide guidance for adhering to the PEP plan. The PEP intervention will be mutually planned with each teen and parent based upon the assessment of the teen's personal and cultural choices, including family and community resources. Exercise frequency, duration, and intensity for the teen with diabetes will be documented with a MTI ActiGraph accelerometer (Fort Walton Beach, FL).

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
exercise adherenceLongitudinal and following the 16-week intervention

Secondary

MeasureTime frame
cardiorespiratory fitnessFollowing the 16-week intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026