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

Primary Purpose

Cardiovascular, Diabetes, Orthostatic Hypotension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control Phase; Exercise Phase
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiovascular focused on measuring Aging, Type 2 diabetes, exercise, walking, glucose metabolism, arterial baroreceptors, heart rate variability, cerebral autoregulation, tilt table study, transcranial Doppler, autonomic nervous system

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VITALiTY Research Centre - VGH Research Pavilion
  • Dr. Scott Lear's Lab, Simon Fraser University, Harbour

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Control Phase; Exercise Phase

Arm 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).

Outcomes

Primary Outcome Measures

Pulse wave velocity (central and peripheral)
Drop in middle cerebral artery velocity with upright tilting
Drop in blood pressure with upright tilt
Arterial baroreflex sensitivity

Secondary Outcome Measures

Fasting blood glucose, HgbA1C
VO2max
Dynamometry measures of muscle strength
Resting and maximal heart rate
Waist to hip ratio, BMI
Lean body mass/% fat
Catecholamines
Increase in Gosling's pulsatility index

Full Information

First Posted
January 14, 2009
Last Updated
April 12, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00824330
Brief Title
Home-Based Walking Study in Older Adults With Type 2 Diabetes
Official Title
The Use of a Home-based Walking Program to Treat Orthostatic Hypotension in Older Adults With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Phase; Exercise Phase
Arm Type
Other
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Control Phase; Exercise Phase
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulse wave velocity (central and peripheral)
Time Frame
Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Title
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
Title
Drop in blood pressure with upright tilt
Time Frame
Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Title
Arterial baroreflex sensitivity
Time Frame
Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Secondary Outcome Measure Information:
Title
Fasting blood glucose, HgbA1C
Time Frame
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Title
VO2max
Time Frame
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Title
Dynamometry measures of muscle strength
Time Frame
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Title
Resting and maximal heart rate
Time Frame
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Title
Waist to hip ratio, BMI
Time Frame
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Title
Lean body mass/% fat
Time Frame
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Title
Catecholamines
Time Frame
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Title
Increase in Gosling's pulsatility index
Time Frame
Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Madden
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karim Miran-Khan
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Janet McElhaney
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
VITALiTY Research Centre - VGH Research Pavilion
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Dr. Scott Lear's Lab, Simon Fraser University, Harbour
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6B 5K3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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