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Completed

NCT Number: NCT00824330

Home-Based Walking Study 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Scott Lear's Lab, Simon Fraser University, Harbour, Vancouver, British Columbia, Canada

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About this study

Detailed Summary

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Control Phase; Exercise Phase

Behavioral

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.

Primary outcomes

  1. Pulse wave velocity (central and peripheral)

    Time frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase

  2. 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

  3. Drop in blood pressure with upright tilt

    Time frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase

  4. Arterial baroreflex sensitivity

    Time frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase

Secondary outcomes

  1. Fasting blood glucose, HgbA1C

    Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

  2. VO2max

    Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

  3. Dynamometry measures of muscle strength

    Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

  4. Resting and maximal heart rate

    Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

  5. Waist to hip ratio, BMI

    Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

  6. Lean body mass/% fat

    Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

  7. Catecholamines

    Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

  8. Increase in Gosling's pulsatility index

    Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Jan 16, 2009
Registry last updated
Apr 14, 2017

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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