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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824330
• Other study ID #: H08-02237
• Status: Completed
• Phase: N/A
• First received: January 14, 2009
• Last updated: April 12, 2017
• Start date: January 2009
• Est. completion date: September 2015

Study information

• Verified date: April 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	Dr. Scott Lear's Lab, Simon Fraser University, Harbour	Vancouver	British Columbia
Canada	VITALiTY Research Centre - VGH Research Pavilion	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave velocity (central and peripheral)		Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Primary	Drop in middle cerebral artery velocity with upright tilting		Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Primary	Drop in blood pressure with upright tilt		Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Primary	Arterial baroreflex sensitivity		Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Secondary	Fasting blood glucose, HgbA1C		Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Secondary	VO2max		Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Secondary	Dynamometry measures of muscle strength		Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Secondary	Resting and maximal heart rate		Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Secondary	Waist to hip ratio, BMI		Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Secondary	Lean body mass/% fat		Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Secondary	Catecholamines		Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Secondary	Increase in Gosling's pulsatility index		Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.