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OpenTrials
Completed

NCT Number: NCT00970294

Pilot Project of Health Promotion for People With Diabetes

Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patricia Kluding PhD

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes type II
  • age 40-70

Exclusion criteria

  • hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months
  • significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus
  • recent symptoms of chest discomfort
  • currently smoking or significant pulmonary pathology
  • serious musculoskeletal problems that would limit ability to exercise
  • current active involvement in a regular exercise program (> 3 times per week)
  • open wounds on the weight bearing surface of the feet
  • not able to ambulate independently
  • stroke or other central nervous system pathology
  • stage 2 hypertension (resting blood pressure > 160 systolic or > 100 diastolic)

Treatment and study plan

Health Promotion Program

Behavioral

10 week health promotion program 3-4 times per week

Primary outcomes

  1. Recruitment, Retention, Adherence

    Time frame: 10 weeks

    % of enrolled subjects who completed the trial

Secondary outcomes

  1. Aerobic Fitness

    Time frame: Baseline and at 10 weeks (change score)

    peak VO2 as measured with a graded maximal exercise test on a cycle ergometer

  2. Glycemic Control

    Time frame: Baseline and at 10 weeks (change score)

    HbA1c measure

Sponsors and collaborators

Lead sponsor

Patricia Kluding, PhD

Other

Registry information

Official study title

Feasibility and Effectiveness of a Health Promotion Program on Aerobic Fitness and Glycemic Control for Adults With Type 2 Diabetes

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 2, 2009
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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