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Trial record 14 of 23 for:    Open Studies | "Hypotension, Orthostatic"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00824330
First received: January 14, 2009
Last updated: July 16, 2014
Last verified: July 2014
  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: Control Phase; Exercise Phase

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:


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: 16
Study Start Date: January 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Gale Tedder, RN, BSN 604-875-5115 gale.tedder@vch.ca
Contact: Chris Lockhart, BSc 604-875-4111 ext 68535 chris.lockhart@vch.ca

Locations
Canada, British Columbia
Dr. Scott Lear's Lab, Simon Fraser University, Harbour Recruiting
Vancouver, British Columbia, Canada, V6B 5K3
Contact: Chris Lockhart    604-875-4111 ext 68535      
VITALiTY Research Centre - VGH Research Pavilion Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
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: July 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Aging
Type 2 diabetes
exercise
walking
glucose metabolism
arterial baroreceptors
heart rate variability
cerebral autoregulation
tilt table study
transcranial Doppler
autonomic nervous system

Additional relevant MeSH terms:
Hypotension, Orthostatic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypotension
Autonomic Nervous System Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014