Home-Based Walking Study in Older Adults With Type 2 Diabetes

April 12, 2017 updated by: Kenneth Madden, University of British Columbia

The Use of a Home-based Walking Program to Treat Orthostatic Hypotension in Older Adults With Type 2 Diabetes

Older persons with diabetes have a harder time maintaining blood pressure when standing up. When blood pressure drops when standing up, fainting may occur. This study will see how regular exercise can improve the ability of the body to keep blood pressure up when standing. We want to see how this improvement varies with a home-based walking program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed Summary

  1. PURPOSE: Older adults with diabetes faint frequently, due to an impairment in the cardiovascular control mechanisms (arterial baroreceptor function, autonomic nervous system function and cerebral autoregulation) that prevent syncope. The purpose of this study is to examine the ability of a home based walking program to reverse these impairments.

  2. HYPOTHESES: a) A home-based walking program will improve the compensatory cardiovascular responses that prevent syncope in older adults with Type 2 diabetes. A moderate, regular exercise program will:

    • increase arterial baroreflex sensitivity
    • increase heart rate variability (marker of autonomic nervous system function)
    • decrease cerebrovascular resistance

    • improve cerebral autoregulation during upright tilt. b) There will be relationship between the improvement in compensatory cardiovascular responses and regular exercise.

      c) Design of more practicable training prescriptions than that used in a research setting.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • VITALiTY Research Centre - VGH Research Pavilion
      • Vancouver, British Columbia, Canada, V6B 5K3
        • Dr. Scott Lear's Lab, Simon Fraser University, Harbour

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes for at least 5 years treated with diet alone or oral agents
  • Nonsmoker for at least 5 years
  • Subjects must be sedentary (as defined by no strength training and less than 30 minutes brisk walking/moderate exercise per week and no vigorous exercise in the preceding 6 months)
  • All subjects will have a fasting glucose of <12 mM and a hemoglobin A1c < 8.5%
  • Orthostatic hypotension defined as a decrease in systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of assuming an upright posture on the initial screening visit as per current American Academy of Neurology guidelines.

Exclusion Criteria:

  • Abnormalities on complete blood count, electrolytes or creatinine, on resting ECG, treadmill exercise stress test
  • Significant pulmonary, exercise-limiting orthopedic or neurological impairment
  • Evidence of valvular disease, exercise-induced syncope, angina, arrhythmias or peripheral vascular disease
  • Poor blood pressure control as defined as systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg
  • Total cholesterol/HDL cholesterol greater than or equal to 5.0 or LDL cholesterol greater than or equal to 4.21 mmol/L
  • Peripheral neuropathy severe enough to cause discomfort (for safety reasons)
  • Overt diabetic nephropathy excluding subjects with a urine albumin to creatinine ratio of greater than 2.0 in men or 2.8 in women
  • Diabetic retinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Phase; Exercise Phase

Participants act as their own control.

Control Phase:

Participants will not change their activity during the 3 month control phase (defined as no strength training and less than 30 minutes brisk walking/moderate exercise per week, no vigorous exercise) Baseline measures will be obtained.

Exercise Phase:

This phase will consist of a Titration phase followed by an Intervention Phase. During the Titration phase, under the guidance of a trainer, subjects will increase their number of steps by 20% per week until they have reached 10,000 steps or 3 months have passed. During the Intervention Phase subjects will continue to walk 10,000 steps (or the number of steps they reached in the Titration phase).
Behavioral: Control Phase; Exercise Phase
After the completion of the control phase and at the start of the titration phase of the study, participants will be given pedometers and log books, then contacted on a regular basis to help insure compliance with the goal of walking 10,000 steps per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulse wave velocity (central and peripheral)
Time Frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Drop in middle cerebral artery velocity with upright tilting
Time Frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Drop in blood pressure with upright tilt
Time Frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Arterial baroreflex sensitivity
Time Frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting blood glucose, HgbA1C
Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
VO2max
Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Dynamometry measures of muscle strength
Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Resting and maximal heart rate
Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Waist to hip ratio, BMI
Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Lean body mass/% fat
Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Catecholamines
Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Increase in Gosling's pulsatility index
Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Kenneth Madden, University of British Columbia
  • Study Director: Karim Miran-Khan, University of British Columbia
  • Study Director: Janet McElhaney, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H08-02237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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