Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment

NCT00998114 | Completed

• 1 other identifier: 1115737
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Dysfunction

Keywords

Early Cardiac Diastolic Dysfunction; Aerobic Exercise; Weight Reduction

Outcome Measures

Primary Outcomes (1)

• Exercise echo Doppler will be done at baseline and after completion of 6 months of an exercise program

  Beginning of study participation and after 6 months of study participation

Study Arms (1)

Exercise and diastolic dysfunction

EXPERIMENTAL

Aerobic exercise for 30-45 minutes five times a week for six months

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Aerobic exercise for 30-45 minutes five times a week for six months

Also known as: Diastolic Dysfunction

Exercise and diastolic dysfunction

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with dyspnea/shortness of breath
• Age 40-65 years of age
• Sedentary lifestyle (\<150 minutes of exercise/week)
• Echocardiographic evidence of early diastolic dysfunction: mitral E/A \<0.9, OR resting E/E' between 8-15 cm/s, OR post-exercise E/E' \>13 cm/s.

You may not qualify if:

• Age \<40 years or \>65 years
• Coronary Artery Disease by angiography or evidence of ischemia on a stress test
• Systolic Dysfunction (LV Ejection fraction \<50%)
• Congestive Heart Failure Functional Class III or IV
• Moderate to severe COPD (FEV \<80% predicted)
• Moderate to severe valvular heart disease, except tricuspid regurgitation
• Inability to get heart rate \>/= 85% of maximum predicted heart rate
• Uncontrolled hypertension (systolic BP\>140mmHg, diastolic BP\>90mmHg) despite medical therapy
• On echocardiogram, RV systolic pressure \>60mmHg that suggests severe pulmonary hypertension
• On echocardiogram, left atrial size\> 6.5 cm or left atrial volume \> 35 ml/BSA

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Harry S Truman Veterans Administration Hospital

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anand Chockalingam, MD

  University of Missouri/Harry S Truman VA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Assoc, Medicine-Cardiology

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 20, 2009
• Study Start: June 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)