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CompletedNCT00387452Updated Apr 14, 2017

Exercise and Cardiovascular Control During Upright Tilt in Older Adults With Type 2 Diabetes

An interventional study of Aerobic Exercise and Strength Exercise and Strength training in Cardiovascular and Diabetic, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-14.

Sponsored by University of British Columbia · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2006, registered Oct 2006).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 different types of exercise. The types of exercise that we will be studying are aerobic (running or cycling on a stationary bike) and strength training (weight lifting).

Read the detailed description
  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 different intensities of aerobic exercise to reverse these impairments.
  2. HYPOTHESES: a) Aerobic or strength training will improve the compensatory cardiovascular responses that prevent syncope in older adults with Type 2 diabetes. Aerobic training 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 aerobic or strength training.

      c) The majority of the benefits of aerobic or strength exercise on the above parameters will with which training, allowing for the design of more practicable training prescriptions than that used in a research setting.

02

Conditions studied

  • Cardiovascular
  • Diabetic

Keywords

  • Aging
  • Type 2 diabetes
  • exercise
  • aerobic training
  • strength training
  • glucose metabolism arterial baroreceptors
  • heart rate variability
  • cerebral autoregulation
  • tilt table study
  • transcranial Doppler
  • autonomic nervous system
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 64 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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)

Exclusion criteria

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) Significant orthostatic hypotension defined as a drop in systolic blood pressure greater than 30 mmHg during one of five consecutive arterial blood pressure readings immediately after changing position from lying to standing for safety.

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

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    1

    Behavioral: Aerobic Exercise and Strength Exercise

  • Active comparator
    2

    Behavioral: Strength training

  • No intervention
    3

    No intervention, only testing during 6 months.

Interventions

  • BehavioralAerobic Exercise and Strength Exercise

    6 months of aerobic training exercise. regulated by heart rate; work up to 80% of maximal heart rate on treadmill or stationary bike; 3 hours a week, 90% attendance.

  • BehavioralStrength training

    6 months of strength training exercise using weight machines involving legs and arms: 12-15 repetitions of weights per exercise; 3 hours a week, 90% attendance.

06

What researchers measure

Primary outcomes

  1. Pulse wave velocity (central and peripheral)

  2. Drop in middle cerebral artery velocity with upright tilting

  3. Drop in blood pressure with upright tilt

  4. Arterial baroreflex sensitivity

  5. Time and frequency domain measures of heart rate variability

Secondary outcomes

  1. Fasting blood glucose, HgbA1C

  2. VO2max

  3. Dynamometry measures of muscle strength

  4. Resting and maximal heart rate

  5. Waist to hip ratio, BMI

  6. Lean body mass/% fat

  7. Catecholamines

  8. Increase in Gosling's pulsatility index

  9. Linear transfer-function analysis of cerebral autoregulation during upright tilt

07

Study locations

1 site
  • Vancouver General Hospital Research Pavilion
    Vancouver, British Columbia V5Z 1L8, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00387452
Lead sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Kenneth Madden (Principal Investigator, University of British Columbia) — Principal investigator
First posted
Oct 13, 2006
Start date
Feb 2006
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Apr 14, 2017

Study contacts

Kenneth Madden, MD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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