Personalized Exercise for Adolescents With Diabetes

NCT00686283 | Completed Phase 1

• 2 other identifiers: RNR009267B7R21NR009267-02
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Adolescents; Diabetes; Exercise

Outcome Measures

Primary Outcomes (1)

• exercise adherence

  Longitudinal and following the 16-week intervention

Secondary Outcomes (1)

• cardiorespiratory fitness

  Following the 16-week intervention

Study Arms (1)

Exercise prescription

OTHER

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

Interventions

PEP intervention BEHAVIORAL

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).

Exercise prescription

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University Medical Center

Tucson, Arizona, 85721, United States

Location

Related Publications (3)

• 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.

  PMID: 30306834 DERIVED

• 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.

  PMID: 23965300 DERIVED

• 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.

  PMID: 20672318 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 29, 2008
• Study Start: August 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)