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Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02473926
Recruitment Status : Active, not recruiting
First Posted : June 17, 2015
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study plans to learn more about physical activity and physical function in sedentary older adults with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Motor Activity Health Behavior Diabetes Mellitus, Type 2 Behavioral: Physical Activity Behavioral: Questionnaires Not Applicable

Detailed Description:
The purpose of this study is to conduct a randomized controlled trial with 1:1 patient-level randomization to an evidence-based physical activity program intervention versus usual care in sedentary older adults with type 2 diabetes in two primary care clinic sites.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
Actual Study Start Date : December 2015
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Activity Program Intervention

The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.

In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.

Behavioral: Physical Activity
Physical Activity Program Intervention

Usual Care Group
Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Behavioral: Questionnaires
Participants in the usual care arm will receive three mailings during the intervention phase.




Primary Outcome Measures :
  1. Change from Baseline in Objective Physical Activity at 4 months [ Time Frame: Week 1; Week 14 ]
    ActiGraph accelerometer measures physical activity objectively as minutes/week of moderate intensity and vigorous intensity physical activity, respectively.


Secondary Outcome Measures :
  1. Change from Baseline in Physical Function at 4 months [ Time Frame: Week 1; week 14 ]
    Measured via 400-meter rapid gait speed test

  2. Change from Baseline in Physical Function at 4 months [ Time Frame: Week 0, Week 14 ]
    Measured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise.

  3. Change from Baseline in Grip Strength at 4 months [ Time Frame: Week 2; Week 15 ]
    Hand grip strength as measured by dynamometer



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Sedentary individual, performing <20 minutes of physical activity on <3 days/week

Exclusion Criteria:

  • Dementia (Folstein Mini-Mental Status Exam <24) or clinical diagnosis
  • Excessive fall risk: Can not hold semi-tandem stance for >10 seconds
  • Type 2 diabetes-related safety concerns: Prior diabetic foot ulcer, Charcot foot, asymptomatic hypoglycemia
  • Severely uncontrolled hypertension (BP >180/100)
  • Excessive hearing or visual impairment for counseling
  • Limited life expectancy: Active treatment for malignancy
  • Performs regular physical activity >20 minutes on >3 days/week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473926


Locations
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United States, Colorado
University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Amy Huebschmann, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02473926     History of Changes
Other Study ID Numbers: 15-1080
K23HL118133 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
Physical Activity
Physical Function
Physical Impairment
Sedentary Lifestyle

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases