Personalized Exercise for Adolescents With Diabetes

• ClinicalTrials.gov Identifier: NCT00686283
• Recruitment Status: Completed
• First Posted: May 29, 2008
• Last Update Posted: May 20, 2014
• Sponsor: University of Arizona
• Information provided by (Responsible Party): Melissa Faulkner, Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes	Behavioral: PEP intervention	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Personalized Exercise for Adolescents With Diabetes
• Study Start Date: August 2007
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm

Intervention/treatment

Exercise prescription; Each adolescents with type 1 or type 2 diabetes received individual fitness testing and a personalized exercise program prescription developed by an exercise physiologist. Pretest and posttest measures of glucose control and cardiorespiratory fitness, heart rate variability, metabolic control, lipid profile, body composition, and inflammatory markers, as well as psychological outcomes (i.e., diabetes quality of life) were completed.

Behavioral: PEP 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).

Outcome Measures

Primary Outcome Measures :

1. exercise adherence [ Time Frame: Longitudinal and following the 16-week intervention ]

Secondary Outcome Measures :

1. cardiorespiratory fitness [ Time Frame: Following the 16-week intervention ]

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Arizona

University Medical Center

Tucson, Arizona, United States, 85721

Sponsors and Collaborators

University of Arizona

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Melissa Faulkner, Associate Dean, Emory University
• ClinicalTrials.gov Identifier: NCT00686283
• Other Study ID Numbers: RNR009267B; 7R21NR009267-02 ( U.S. NIH Grant/Contract )
• First Posted: May 29, 2008
• Last Update Posted: May 20, 2014
• Last Verified: May 2014

Keywords provided by Melissa Faulkner, Emory University:

Adolescents; Diabetes; Exercise

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases