NCT00680290

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

May 15, 2008

Last Update Submit

January 14, 2019

Conditions

Keywords

exercise, quality of life, cpx

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 week

Study Arms (1)

1

EXPERIMENTAL

Exercise group

Procedure: Exercise

Interventions

ExercisePROCEDURE

Exercise x 8 weeks

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Atrial FibrillationMotor ActivityCoproporphyria, Hereditary

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorPorphyrias, HepaticLiver DiseasesDigestive System DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesPorphyriasMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jose A Joglar

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 20, 2008

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations