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

NCT00387452 | Completed

• 2 other identifiers: H04-70001ORSIL# 05-0820
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 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).

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

• Time and frequency domain measures of heart rate variability

Secondary Outcomes (9)

• Fasting blood glucose, HgbA1C

• VO2max

• Dynamometry measures of muscle strength

• Resting and maximal heart rate

• Waist to hip ratio, BMI

Study Arms (3)

1

ACTIVE COMPARATOR

Behavioral: Aerobic Exercise and Strength Exercise

2

ACTIVE COMPARATOR

Behavioral: Strength training

3

NO INTERVENTION

No intervention, only testing during 6 months.

Interventions

Aerobic Exercise and Strength Exercise BEHAVIORAL

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.

1

Strength training BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 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)

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) 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Vancouver General Hospital Research Pavilion

Vancouver, British Columbia, V5Z 1L8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Kenneth Madden, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 13, 2006
• Study Start: February 1, 2006
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)