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

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University of British Columbia

Status

Completed

Conditions

Diabetes
Type 2 Diabetes
Cardiovascular
Orthostatic Hypotension

Treatments

Behavioral: Control Phase; Exercise Phase

Study type

Interventional

Funder types

Other

Identifiers

NCT00824330
H08-02237

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Control Phase; Exercise Phase
Other group
Description:
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).
Treatment:
Behavioral: Control Phase; Exercise Phase

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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