The Effect of Low Intensity Exercise on Quality of Life and Hemodynamics in Patients With Permanent Atrial Fibrillation - Full Text View

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00680290

Purpose

The purpose of this study is to 1) assess the effect of routine exercise on the quality of life of patients with permanent atrial fibrillation, and 2) assess the effect of exercise on cardio-hemodynamics in patients with atrial fibrillation.

Condition	Intervention
Atrial Fibrillation	Procedure: Exercise

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	The Effect of Low Intensity Exercise on Quality of Life and Hemodynamics in Patients With Permanent Atrial Fibrillation

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

to 1) assess the effect of routine exercise on the quality of life of patients with permanent atrial fibrillation, and 2) assess the effect of exercise on cardio-hemodynamics in patients with atrial fibrillation. [ Time Frame: 8 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Exercise group	Procedure: Exercise Exercise x 8 weeks

Detailed Description:

Twelve patients will be enrolled. Each subject will first serve as their own control and then serve in the treatment group. Subjects will be required to sign informed consent prior to any study procedure.
The exercise program will be structured as follows:

At the time of enrollment, patients will undergo an exercise treadmill test to measure cardiac hemodynamics, including VO2max (measured non-invasively using gas exchange) and maximal heart rate. Average heart rate over 24 hours will also be measured by a 24-hour Holter monitor before and after the exercise program. The maximal exercise testing will be performed on a treadmill using an incremental protocol based on the estimated fitness level established during a warm up.

For the first 8-weeks of their participation, patients will act as their own control and not exercise. When the 8 week period is complete, they will return for another exercise treadmill test and 24-hour Holter monitor.

For the second 8-weeks of their participation, patients will participate in exercise training. The initial 2 weeks of exercise will be supervised at the St. Paul University Hospital exercise facility for twenty minutes a day, four times a week. Exercise will be done by walking or use of aerobic exercise equipment, which include a treadmill, elliptical machine, cycle ergometer or rowing machine according to patient preference and availability of exercise facilities at home.

During this period the patients will commence training at an intermediate effort based on perceived exertion (Borg Scale 11-13). The intensity will be gradually increased to a level corresponding to 70-75% VO2max or 15 on the Borg Scale, whichever represents the least effort.

For the remaining six weeks, the patients will continue the exercise program at the perceived intensity learned during the first two weeks of training. During these six weeks, the patients will be asked to exercise for 30 minutes, five times per week.

Participants can exercise at home if they wish, but they will be required to undergo supervised exercise at least once per week during this six week period and will be required to keep an exercise log for monitoring their unsupervised efforts.

At the end of this 8-week program of exercise training, patients will return for a third exercise treadmill test and 24-hour Holter monitor.
The Quality of Life survey will be assessed with two forms, the Short Form 36 (SF 36) and the Arrhythmia Related Symptom Severity Check List (SSCL). Patients will be asked to fill out both the SF 36 QOL and SSCL QOL survey and submit to a Physical Activity Recall (PAR) interview each time they have the exercise treadmill test and 24-hour Holter.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with permanent atrial fibrillation for at least three months duration, on stable medical therapy and in whom no additional interventions are planned to treat AF either due to clinical reasons or patient preferences
Have the ability to understand and sign consent to participate and be willing and able to comply with prescribed exercise and schedule of evaluations
Sedentary lifestyle as determined by Physical Activity Recall (PAR)
Be greater than 18 years of age

Exclusion Criteria:

Inability to exercise
Functional Class IV CHF symptoms
Active symptoms of angina, coronary artery disease
Patient with recent history of myocardial infarction
Patient with moderate or severely depressed left ventricular function (LVEF < 40 %)
Patient with any significant co-morbidities that may limit ability to exercise
Patients already engaged a structured exercise program

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680290

Locations

United States, Texas
UT Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: Carol Nguyen 214-590-5015 Carol.Nguyen@UTSouthwestern.edu
Principal Investigator: Jose A Joglar

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:

Jose A Joglar

UT Southwestern Medical Center

More Information

Responsible Party:	UT Southwestern Medical Center ( Jose Joglar, MD )
Study ID Numbers:	UTSW IRB 072004-047
Study First Received:	May 15, 2008
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00680290
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

exercise, quality of life, cpx

Study placed in the following topic categories:

Heart Diseases
Quality of Life
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009