Atrial FibrillationNCT00680290
The Effect of Low Intensity Exercise on Quality of Life and Hemodynamics in Patients With Permanent Atrial Fibrillation
A study testing Exercise in people with Atrial Fibrillation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Exercise
- Keywords
- exercise, quality of life, cpx
- Medical subject headings
- Atrial Fibrillation, Motor Activity, Coproporphyria, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
Exercise x 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise group Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose A Joglar, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680290
- Sponsor's protocol ID
- UTSW IRB 072004-047
- Status last verified
- Jan 2019
- First submitted
- 15 May 2008
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Intensity Exercise on Quality of Life and Hemodynamics in Patients With Permanent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00680290
- Acronym / sponsor ID
- UTSW IRB 072004-047
- Conditions
- Atrial Fibrillation
- Keywords
- exercise, quality of life, cpx
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: ExerciseExercise group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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 %)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise x 8 weeks | Procedure or surgery | 1 |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Joglar principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Atrial Fibrillation, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.