Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment
| Tracking Information | |||||
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| First Received Date ICMJE | October 19, 2009 | ||||
| Last Updated Date | June 15, 2011 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Exercise echo Doppler will be done at baseline and after completion of 6 months of an exercise program [ Time Frame: Beginning of study participation and after 6 months of study participation ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00998114 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment | ||||
| Official Title ICMJE | Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment | ||||
| Brief Summary | The project aims to investigate the effect of a regular exercise for 6 months on diastolic parameters in patients who present with shortness of breath and who have evidence of early diastolic dysfunction on echocardiography. Patients will be enrolled from the VA General Medicine and Cardiology Clinics, and will be screened for diastolic dysfunction. Once enrolled, they will be on an exercise regimen that involves aerobic exercise for 30-45 minutes five times a week at home. The participants will have an initial supervised exercise session with the VA Cardiac Rehabilitation team, and will have either every other week or monthly supervised sessions at the VA Cardiac Rehabilitation Center to monitor their progress. Clinical, biometric, laboratory and echocardiographic parameters will be obtained before and after the 6 month period. |
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| Detailed Description | Introduction: Diastolic dysfunction (DD) accounts for >50% of all heart failure (DHF) hospitalizations and this number is increasing with age, obesity and diabetes. There are no proven treatments for DHF apart from blood pressure control. Aim: If diagnosed early, is this reversible with lifestyle changes; namely, aerobic exercise and weight reduction? Methods: We will screen veterans presenting to the medicine, cardiology and pulmonary services with dyspnea. We will perform echocardiography with Doppler which non-invasively measures cardiac filling and diastolic dysfunction. Treadmill exercise echo will be performed to quantify DD. Bruce treadmill protocol description/ procedure: Exercise is performed on a treadmill. The test starts at 2.74 km/hr (1.7 mph) and at a gradient (or incline) of 10%. At three minute intervals the incline of the treadmill increases by 2%, and the speed increases as shown in the table below. Stage Speed (mph) Gradient:
Subject exercise study: For physical exercise to have a beneficial effect on cardiac function, we suggest the following:
Duration of Exercise: Initial 2-3 minute gradual warm-up period. Roughly 30 minutes of continuous exercise 5 times a week. Finally a few minutes of gradual cool-down before terminating exercise. Intensity of Exercise: Target exercise at a "moderately significant exertion". We will demonstrate what is adequate in the beginning and periodically throughout the 6 months of the study. "Maximum age predicted heart rate (MPHR)" is calculated as 220 minus subject's age. Then we would like to sustain roughly about 70 to 85% of MPHR for 25-30 minutes. "Successful" Exerciser: Subjects who are able to adhere to the required intensity and duration of exercise for the majority (about 75% or more) of the time; averaging 150 minutes/ week on self reporting. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Diastolic Dysfunction | ||||
| Intervention ICMJE | Behavioral: Exercise
Aerobic exercise for 30-45 minutes five times a week for six months
Other Name: Diastolic Dysfunction |
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| Study Arm (s) | Experimental: Exercise and diastolic dysfunction
Intervention: Behavioral: Exercise |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00998114 | ||||
| Other Study ID Numbers ICMJE | 1115737 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Anand Chockalingam, MD, Assistant Clinical Professor of Medicine, University of Missouri | ||||
| Study Sponsor ICMJE | University of Missouri-Columbia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Missouri-Columbia | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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