CardiovascularNCT00824330
Home-Based Walking Study in Older Adults With Type 2 Diabetes
A study of Cardiovascular and Diabetes, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular, Diabetes, Orthostatic Hypotension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2009to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
VITALiTY Research Centre - VGH Research Pavilion
Vancouver, British Columbia, V5Z 1M9
Dr. Scott Lear's Lab, Simon Fraser University, Harbour
Vancouver, British Columbia, V6B 5K3
About this study
Official title: The Use of a Home-based Walking Program to Treat Orthostatic Hypotension in Older Adults With Type 2 Diabetes
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.
Read the 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.
- Design of more practicable training prescriptions than that used in a research setting.
- Conditions
- Cardiovascular, Diabetes, Orthostatic Hypotension, Type 2 Diabetes
- Being tested
- Control Phase; Exercise Phase
- Keywords
- Aging, Type 2 diabetes, exercise, walking, glucose metabolism, arterial baroreceptors, heart rate variability, cerebral autoregulation, tilt table study, transcranial Doppler, autonomic nervous system
- Medical subject headings
- Diabetes Mellitus, Hypotension, Orthostatic, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Phase; Exercise PhaseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Control Phase; Exercise Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity (central and peripheral)
Measured: 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: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Drop in blood pressure with upright tilt
Measured: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Arterial baroreflex sensitivity
Measured: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Secondary outcomes (8)
Fasting blood glucose, HgbA1C
Measured: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
VO2max
Measured: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Dynamometry measures of muscle strength
Measured: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Resting and maximal heart rate
Measured: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Waist to hip ratio, BMI
Measured: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Lean body mass/% fat
Measured: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Catecholamines
Measured: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Increase in Gosling's pulsatility index
Measured: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Madden, University of British Columbia
- Investigators
- Kenneth Madden, Principal investigator, University of British ColumbiaKarim Miran-Khan, Study director, University of British ColumbiaJanet McElhaney, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824330
- Sponsor's protocol ID
- H08-02237
- Status last verified
- Apr 2017
- First submitted
- 14 Jan 2009
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Home-based Walking Program to Treat Orthostatic Hypotension in Older Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00824330
- Acronym / sponsor ID
- H08-02237
- Conditions
- Cardiovascular, Diabetes, Orthostatic Hypotension, Type 2 Diabetes
- Keywords
- Aging, Type 2 diabetes, exercise, walking, glucose metabolism, arterial baroreceptors, heart rate variability, cerebral autoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Design of more practicable training prescriptions than that used in a research setting.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control Phase; Exercise Phase | Other | Behavioral: Control Phase; Exercise PhaseParticipants 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Phase; Exercise PhaseAfter 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. | Behavioural | Control Phase; Exercise Phase |
Primary outcome
Pulse wave velocity (central and peripheral)
Time frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
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
Drop in blood pressure with upright tilt
Time frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Arterial baroreflex sensitivity
Time frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
8 secondary outcomes
Fasting blood glucose, HgbA1C
Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
VO2max
Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Dynamometry measures of muscle strength
Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Resting and maximal heart rate
Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Waist to hip ratio, BMI
Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Lean body mass/% fat
Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Catecholamines
Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Increase in Gosling's pulsatility index
Time frame: Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Madden principal investigator
University of British Columbia
Karim Miran-Khan study director
University of British Columbia
Janet McElhaney study director
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiovascular and Diabetes, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (central and peripheral) (time frame: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017; AzTrials last refreshed its copy on 29 Oct 2026.