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

NCT00824330 | Completed

• 1 other identifier: H08-02237
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Pulse wave velocity (central and peripheral)

  Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase

• Drop in middle cerebral artery velocity with upright tilting

  Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase

• Drop in blood pressure with upright tilt

  Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase

• Arterial baroreflex sensitivity

  Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase

Secondary Outcomes (8)

• Fasting blood glucose, HgbA1C

  Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

• VO2max

  Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

• Dynamometry measures of muscle strength

  Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

• Resting and maximal heart rate

  Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

• Waist to hip ratio, BMI

  Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.

Study Arms (1)

Control Phase; Exercise Phase

OTHER

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

Interventions

Control Phase; Exercise Phase 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.

Control Phase; Exercise Phase

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

VITALiTY Research Centre - VGH Research Pavilion

Vancouver, British Columbia, V5Z 1M9, Canada

Location

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

Vancouver, British Columbia, V6B 5K3, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypotension, Orthostatic; Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Kenneth Madden

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Karim Miran-Khan

  University of British Columbia

  STUDY DIRECTOR

• Janet McElhaney

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, VGH Division of Geriatric Medicine

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2015
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)