Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00824330
Enrollment
13
Registered
2009-01-16
Start date
2009-01-31
Completion date
2015-09-30
Last updated
2017-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular, Diabetes, Orthostatic Hypotension, Type 2 Diabetes

Keywords

Aging, Type 2 diabetes, exercise, walking, glucose metabolism, arterial baroreceptors, heart rate variability, cerebral autoregulation, tilt table study, transcranial Doppler, autonomic nervous system

Brief summary

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.

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.

Interventions

BEHAVIORALControl 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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pulse wave velocity (central and peripheral)Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Drop in middle cerebral artery velocity with upright tiltingMeasured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Drop in blood pressure with upright tiltMeasured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Arterial baroreflex sensitivityMeasured at Baseline, 3 months after control phase and after 3 months of Intervention phase

Secondary

MeasureTime frame
Waist to hip ratio, BMIMeasured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Lean body mass/% fatMeasured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Fasting blood glucose, HgbA1CMeasured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Increase in Gosling's pulsatility indexMeasured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
CatecholaminesMeasured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
VO2maxMeasured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Dynamometry measures of muscle strengthMeasured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Resting and maximal heart rateMeasured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026