Coronary Artery Bypass GraftNCT01591642
Physical Activity, Functional Fitness and Quality of Life After Coronary Artery Bypass Grafting
An observational study of Coronary Artery Bypass Graft, run by Far Eastern Memorial Hospital.
Trial summary
The main purposes of this study are: (1) to investigate the difference of the physical fitness, and quality of life (QOL) among different physical activity levels in post-coronary artery bypass graft (CABG) patients; (2) to analyze the relationships between physical activity and physical fitness and QOL in this… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2011
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: . All patients who underwent CABG at the Department of Cardiovascular Center at Far-Eastern Memorial Hospital since January 2000 were selected for recruitment to this study.
Who may be able to join
- patients undergoing CABG without valve surgery
Who cannot join
- systemic disease, such as liver, renal disease,
- amputation,
- cerebrovascular disease or any others disease with limbs dysfunction,
- lung deficit,
- cancer,
- cognitive disorders.
About this study
The main purposes of this study are: (1) to investigate the difference of the physical fitness, and quality of life (QOL) among different physical activity levels in post-coronary artery bypass graft (CABG) patients; (2) to analyze the relationships between physical activity and physical fitness and QOL in this population. The investigators predict physical activity and physical fitness remain limited in patients after CABG, and patients with higher physical activity levels will have higher QOL and physical fitness.
Read the detailed description
Heart diseases continue as the top 3 causes of death in Taiwan in recent ten years. Coronary artery disease (CAD) is the most prevalent fatal heart disease. Coronary artery bypass graft surgery (CABG) is now one of the most common procedures to treat CAD. It was reported that CABG intervention could prolong the life. However, outcomes of CABG have historically been measured in terms of mortality and recurrence of symptoms or complications.There is ample evidence to demonstrate the effect and benefit of cardiac rehabilitation in QOL and function activity in patients post CABG. However, the participation rate of postoperative cardiac rehabilitation is low, especially in women.Little research has been done to examine the physical activity, physical performance, and QOL in this population outside the cardiac rehabilitation setting.
- Conditions
- Coronary Artery Bypass Graft
- Keywords
- physical activity, functional fitness, quality of life
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
The level of physical activity was evaluated by the self-administrated long form of the International Physical Activity Questionnaire, which was permitted by the Bureau of Health Promotion, Department of Health, R.O.C.(Taiwan). It is an instrument that estimates the weekly time spent on the performance of physical activities according to intensity, in different contexts of life (workplace, household tasks, transport and leisure). Reported minutes per week in each category were weighted by a metabolic equivalent (MET; multiples of resting energy expenditure).
Measured: The participants were followed at one time points after operation in past 10 years
Secondary outcomes (2)
physical fitness
Physical fitness The outcome measures of physical fitness included body mass index(BMI), waist circumference(WC), grip strength, 30-second chair stand test, and six-minute walk test(6MWT).
Measured: The participants were followed at one time points after operation in past 10 years
quality of life
QOL was measured using abbreviated version of the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire. The original WHOQOL-BREF comprised 26 questions and included four domains: physical, psychological, social relationships, and environment. The WHOQOL-BREF scale has been adapted for Taiwan and added two questions appropriate for Taiwanese culture.
Measured: The participants were followed at one time points after operation in past 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591642
- Sponsor's protocol ID
- FEMH-IRB-099087-E
- Status last verified
- Oct 2010
- First submitted
- 27 Apr 2012
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Functional Fitness and Quality of Life After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01591642
- Acronym / sponsor ID
- FEMH-IRB-099087-E
- Conditions
- Coronary Artery Bypass Graft
- Keywords
- physical activity, functional fitness, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 May 2012 (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 main purposes of this study are: (1) to investigate the difference of the physical fitness, and quality of life (QOL) among different physical activity levels in post-coronary artery bypass graft (CABG) patients; (2) to analyze the relationships between physical activity and physical fitness and QOL in this population. The investigators predict physical activity and physical fitness remain limited in patients after CABG, and patients with higher physical activity levels will have higher QOL and physical fitness.
Detailed description
Heart diseases continue as the top 3 causes of death in Taiwan in recent ten years. Coronary artery disease (CAD) is the most prevalent fatal heart disease. Coronary artery bypass graft surgery (CABG) is now one of the most common procedures to treat CAD. It was reported that CABG intervention could prolong the life. However, outcomes of CABG have historically been measured in terms of mortality and recurrence of symptoms or complications.There is ample evidence to demonstrate the effect and benefit of cardiac rehabilitation in QOL and function activity in patients post CABG. However, the participation rate of postoperative cardiac rehabilitation is low, especially in women.Little research has been done to examine the physical activity, physical performance, and QOL in this population outside the cardiac rehabilitation setting.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- . All patients who underwent CABG at the Department of Cardiovascular Center at Far-Eastern Memorial Hospital since January 2000 were selected for recruitment to this study.
Key inclusion criteria (1 listed)
- patients undergoing CABG without valve surgery
Key exclusion criteria (6 listed)
- systemic disease, such as liver, renal disease,
- amputation,
- cerebrovascular disease or any others disease with limbs dysfunction,
- lung deficit,
- cancer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
physical activity
Time frame: The participants were followed at one time points after operation in past 10 years
The level of physical activity was evaluated by the self-administrated long form of the International Physical Activity Questionnaire, which was permitted by the Bureau of Health Promotion, Department of Health, R.O.C.(Taiwan). It is an instrument that estimates the weekly time spent on the performance of physical activities according to intensity, in different contexts of life (workplace, household tasks, transport and leisure). Reported minutes per week in each category were weighted by a metabolic equivalent (MET; multiples of resting energy expenditure).
2 secondary outcomes
physical fitness
Time frame: The participants were followed at one time points after operation in past 10 years
quality of life
Time frame: The participants were followed at one time points after operation in past 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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Coronary Artery Bypass Graft (CABG)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Graft, run by Far Eastern Memorial Hospital.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
physical activity (time frame: The participants were followed at one time points after operation in past 10 years). 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 4 May 2012.