Home-Based Walking Study - Full Text View

Purpose

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.

Condition	Intervention
Cardiovascular Diabetes Orthostatic Hypotension Type 2 Diabetes	Behavioral: Home-based walking program (Aerobic Exercise)

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics/Dynamics Study
Official Title:	The Use of a Home-based Walking Program to Treat Orthostatic Hypotension in Older Adults With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Exercise and Physical Fitness Low Blood Pressure

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Pulse wave velocity (central and peripheral) [ Time Frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Drop in blood pressure with upright tilt [ Time Frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase ] [ Designated as safety issue: No ]
Arterial baroreflex sensitivity [ Time Frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting blood glucose, HgbA1C [ Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. ] [ Designated as safety issue: No ]
VO2max [ Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. ] [ Designated as safety issue: No ]
Dynamometry measures of muscle strength [ Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. ] [ Designated as safety issue: No ]
Resting and maximal heart rate [ Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. ] [ Designated as safety issue: No ]
Waist to hip ratio, BMI [ Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. ] [ Designated as safety issue: No ]
Lean body mass/% fat [ Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. ] [ Designated as safety issue: No ]
Catecholamines [ Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. ] [ Designated as safety issue: No ]
Increase in Gosling's pulsatility index [ Time Frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Participants act as their own control. Participants go through a control phase where baseline measures are obtained and the intervention is not present, then move to an intervention phase where they will be exercising	Behavioral: Home-based walking program (Aerobic Exercise) After the completion of the control 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 10000 steps per day.

Detailed 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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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
BMI between 24 and 35
All subjects will have a fasting glucose of <12 mM and a hemoglobin A1c < 8.5%
All subjects must have developed hypertension CDA guidelines (systolic greater than 130 or diastolic greater than 80)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824330

Contacts

Contact: Chris Lockhart

(604) 875-4111 ext 68535

Locations

Canada, British Columbia
VITALiTY Research Centre - VGH Research Pavilion	Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Chris Lockhart 604-875-4111 ext 68535
Dr. Scott Lear's Lab, Simon Fraser University, Harbour	Recruiting
Vancouver, British Columbia, Canada, V6B 5K3
Contact: Chris Lockhart 604-875-4111 ext 68535

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:	Kenneth Madden	University of British Columbia
Study Director:	Karim Miran-Khan	University of British Columbia
Study Director:	Janet McElhaney	University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00824330 History of Changes
Other Study ID Numbers:	H08-02237
Study First Received:	January 14, 2009
Last Updated:	November 23, 2011
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

walking
Aging
Type 2 diabetes
exercise
glucose metabolism
arterial baroreceptors

heart rate variability
cerebral autoregulation
tilt table study
transcranial Doppler
autonomic nervous system

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypotension
Hypotension, Orthostatic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013