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

NCT ID: NCT00824330

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Cardiovascular; Diabetes; Orthostatic Hypotension; Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Control Phase; Exercise Phase

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Madden

Head, VGH Division of Geriatric Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Madden

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Karim Miran-Khan

Role: STUDY_DIRECTOR

University of British Columbia

Janet McElhaney

Role: STUDY_DIRECTOR

University of British Columbia

Locations

VITALiTY Research Centre - VGH Research Pavilion

Vancouver, British Columbia, Canada

Dr. Scott Lear's Lab, Simon Fraser University, Harbour

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H08-02237

Identifier Type: -

Identifier Source: org_study_id