Heart Failure PatientsNCT03701854
Physical Impairments in Heart Failure Patients With Pacemakers
An observational study of Heart Failure Patients, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Despite major breakthroughs that have recently been made in pacemakers implanted in heart failure (HF) patients, it is clear that functional impairments and symptoms often remain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure Patients
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 30 Aug 2018
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prior to evaluation, all patients' clinical evaluation and echocardiographic measurements and pacemaker routine controls were conducted by a cardiologist. All patients and controls were tested by a physical therapist. Demographic characteristics were recorded. Functional and maximal exercise capacity, respiratory and peripheral muscle strength, pulmonary function, dyspnea and fatigue perception were evaluated and compared with age- and gender-matched healthy controls (without any chronic diseases) who volunteered to participate to the study.
Who may be able to join
- Heart failure patients with ischemic or non-ischemic etiology,
- Aged between 18 and 80 years,
- Being clinically stable for at least 4 weeks,
- Having any type of implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT), New York Heart Association (NYHA) Class II-III,
- Having no change in medications over three months and all comorbid conditions, such as hypertension and diabetes, controlled.
Who cannot join
- Having acute myocardial infarction, cognitive disorders, complex arrhythmias, uncontrolled hypertension, stroke or transient ischemic attack within the last six months prior to the study, angina pectoris, recent viral infections (six months prior to study), significant valvular disease,
- Having history of malignancy,
- Having orthopedic problems and rheumatologic diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Science Department of PhysioTherapy
Ankara, 06560
About this study
Official title: Comparison of Functional and Maximal Exercise Capacity, Respiratory and Peripheral Muscle Strength, Dyspnea and Fatigue in Heart Failure Patients With Pacemakers and Healthy Controls
Despite major breakthroughs that have recently been made in pacemakers implanted in heart failure (HF) patients, it is clear that functional impairments and symptoms often remain. However, only limited studies have investigated exercise capacity, muscle strength, pulmonary function, dyspnea, and fatigue in pacemaker implanted HF patients. Therefore, investigators aimed to compare the aforementioned outcomes in patients and healthy controls.
Read the detailed description
Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body's needs for blood and oxygen. Safeguarding HF patients at increased risk of sudden cardiac death due to ventricular arrhythmias and HF as a result of left ventricular systolic dysfunction and cardiac abnormal synchronization has continued to improve. Implantable cardioverter defibrillators (ICDs), which restore normal heart rhythm using pacing, cardioversion or defibrillation, and cardiac resynchronization therapy (CRT), which resynchronizes the contraction of the heart using biventricular pacing, are nowadays widely used to treat the aforementioned conditions.
New developments in medical treatments have focused on the primary affected organs, targeting reduced left ventricular ejection fraction in chronic HF. Although major breakthroughs in the treatments have occurred in recent years, especially implantable medical devices, it is clear that when drugs are optimally prescribed, even the latest technology used in pacemakers reported problems, especially functional impairments and symptoms often remain. In recent decades, it has become obvious that disease severity should not be estimated from cardiac function impairment alone. However, what has not hitherto been clearly investigated is the fact that even functional and maximal exercise capacity, respiratory and peripheral muscle strength and pulmonary function are impaired, and dyspnea in the activities of daily living and fatigue perception increased in HF patients with pacemakers.
Hence, investiators designed a prospective, cross-sectional study to compare the aforementioned outcomes in HF patients with pacemakers and healthy controls. Investigators hypothesized that functional and maximal exercise capacity, respiratory and peripheral muscle strength, and pulmonary function are impaired, and dyspnea in the activities of daily living, and fatigue perception increased in HF patients with pacemakers.
A cross-sectional study. 50 HF patients with pacemakers and 40 controls were compared. Functional (6-Minute Walking test (6-MWT)) and maximal exercise capacity (Incremental Shuttle Walking test (ISWT)), respiratory (MIP, MEP; Mouth pressure device) and peripheral muscle strength (Dynamometer), pulmonary function (Spirometry) dyspnea (Modified Medical Research Council Dyspnea scale) (MMRC)), and fatigue (Fatigue Severity scale (FSS)) were evaluated.
- Conditions
- Heart Failure Patients
- Keywords
- heart failure, pacemaker, exercise test, muscle strength, dyspnea, fatigue
- Medical subject headings
- Heart Failure, Dyspnea, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients with pacemakers | Functional (6-Minute Walking test (6-MWT)) and maximal exercise capacity (Incremental Shuttle Walking test (ISWT)), respiratory (MIP, MEP; Mouth pressure device) and peripheral muscle strength (Dynamometer), pulmonary function (Spirometry) dyspnea (Modified Medical Research Council Dyspnea scale) (MMRC)), and fatigue (Fatigue Severity scale (FSS)) were evaluated in 50 patients. | |
| Healthy controls | Healthy individuals (n=40) were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
submaximal exercise capacity evaluation
The six-minute walking test (6-MWT) was used to evaluate submaximal exercise capacity.
Measured: 8-10 minutes
Secondary outcomes (6)
pulmonary function test
This test was evaluated using a spirometry by which is evaluated dynamic lung functions expressed as percentages of expected values.
Measured: 5 minutes
inspiratory and expiratory muscle strength (MIP, MEP)
Respiratory muscle strength was evaluated with a mouth pressure device
Measured: 5-10 minutes
peripheral muscle strength
Peripheral muscle strength was evaluated with a hand-held dynamometer
Measured: 10 minutes
fatigue severity
The Turkish version of Fatigue Severity Scale, which is a valid and reliable test, was performed to the recipients for evaluation of fatigue severity. Self-administered questionnaire is comprised of nine questions. The average score is identified on seven-point scale. Patients select a number from 1 to 7 for each 9 questions which demonstrates from strong disagreement to strong agreement, respectively. The cut-off score for fatigue severity is 36 according to this scale, if the total score obtained from this scale is higher than 36, the recipient is defined as severe fatigue.
Measured: 1-3 minutes
Dyspnea severity
The severity of dyspnea during daily living activities was evaluated using the Modified Medical Research Council (MMRC) dyspnea scale. Dyspnea is graded as follows: zero (dyspnea only with strenuous exercise), one (dyspnea when hurrying or walking up a slight hill), two (walks slower than people of the same age due to dyspnea or having to stop for breath when walking at own pace), three (stops for breath after walking 100 yards or after a few minutes) and four (too dyspneic to leave house or breathless when dressing). The minimal clinically important difference (MCID) is 1 unit for the MMRC dyspnea scale.
Measured: 2 minutes
maximal exercise capacity evaluation
and the incremental shuttle walk test (ISWT) was used to evaluate submaximal exercise capacity.
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Jan 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Failure PatientsStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Meral Boşnak Güçlü, PhD, Study director, Gazi UniversityGülşah Barğı, PhD, Study chair, Gazi UniversityNihan Katayıfçı, MsC, Study chair, Mustafa Kemal Üniversitesi Fizik Tedavi ve Rehabilitasyon Yüksekokulu Fizyoterapi ve Rehabilitasyon BölümüFatih Şen, PhD., Study chair, Mustafa Kemal Üniversitesi Tayfur Ata Sökmen Tıp Fakültesi Kardiyoloji Anabilim Dalı
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701854
- Sponsor's protocol ID
- GaziUniversity16
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.
Publications
Jonsdottir S, Andersen KK, Sigurosson AF, Sigurosson SB. The effect of physical training in chronic heart failure. Eur J Heart Fail. 2006 Jan;8(1):97-101. doi: 10.1016/j.ejheart.2005.05.002. Epub 2005 Sep 27.
PubMed 16194620Clark AL. Origin of symptoms in chronic heart failure. Heart. 2006 Jan;92(1):12-6. doi: 10.1136/hrt.2005.066886. Epub 2005 Sep 13.
PubMed 16159969Volterrani M, Clark AL, Ludman PF, Swan JW, Adamopoulos S, Piepoli M, Coats AJ. Predictors of exercise capacity in chronic heart failure. Eur Heart J. 1994 Jun;15(6):801-9. doi: 10.1093/oxfordjournals.eurheartj.a060588.
PubMed 8088269Buller NP, Jones D, Poole-Wilson PA. Direct measurement of skeletal muscle fatigue in patients with chronic heart failure. Br Heart J. 1991 Jan;65(1):20-4. doi: 10.1136/hrt.65.1.20.
PubMed 1993126Minotti JR, Pillay P, Chang L, Wells L, Massie BM. Neurophysiological assessment of skeletal muscle fatigue in patients with congestive heart failure. Circulation. 1992 Sep;86(3):903-8. doi: 10.1161/01.cir.86.3.903.
PubMed 1516203
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional and Maximal Exercise Capacity, Respiratory and Peripheral Muscle Strength, Dyspnea and Fatigue in Heart Failure Patients With Pacemakers and Healthy Controls
- ClinicalTrials.gov ID
- NCT03701854
- Acronym / sponsor ID
- GaziUniversity16
- Conditions
- Heart Failure Patients
- Keywords
- heart failure, pacemaker, exercise test, muscle strength, dyspnea, fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 10 Oct 2018 (actual)
- 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.
Despite major breakthroughs that have recently been made in pacemakers implanted in heart failure (HF) patients, it is clear that functional impairments and symptoms often remain. However, only limited studies have investigated exercise capacity, muscle strength, pulmonary function, dyspnea, and fatigue in pacemaker implanted HF patients. Therefore, investigators aimed to compare the aforementioned outcomes in patients and healthy controls.
Detailed description
Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body's needs for blood and oxygen. Safeguarding HF patients at increased risk of sudden cardiac death due to ventricular arrhythmias and HF as a result of left ventricular systolic dysfunction and cardiac abnormal synchronization has continued to improve. Implantable cardioverter defibrillators (ICDs), which restore normal heart rhythm using pacing, cardioversion or defibrillation, and cardiac resynchronization therapy (CRT), which resynchronizes the contraction of the heart using biventricular pacing, are nowadays widely used to treat the aforementioned conditions.
New developments in medical treatments have focused on the primary affected organs, targeting reduced left ventricular ejection fraction in chronic HF. Although major breakthroughs in the treatments have occurred in recent years, especially implantable medical devices, it is clear that when drugs are optimally prescribed, even the latest technology used in pacemakers reported problems, especially functional impairments and symptoms often remain. In recent decades, it has become obvious that disease severity should not be estimated from cardiac function impairment alone. However, what has not hitherto been clearly investigated is the fact that even functional and maximal exercise capacity, respiratory and peripheral muscle strength and pulmonary function are impaired, and dyspnea in the activities of daily living and fatigue perception increased in HF patients with pacemakers.
Hence, investiators designed a prospective, cross-sectional study to compare the aforementioned outcomes in HF patients with pacemakers and healthy controls. Investigators hypothesized that functional and maximal exercise capacity, respiratory and peripheral muscle strength, and pulmonary function are impaired, and dyspnea in the activities of daily living, and fatigue perception increased in HF patients with pacemakers.
A cross-sectional study. 50 HF patients with pacemakers and 40 controls were compared. Functional (6-Minute Walking test (6-MWT)) and maximal exercise capacity (Incremental Shuttle Walking test (ISWT)), respiratory (MIP, MEP; Mouth pressure device) and peripheral muscle strength (Dynamometer), pulmonary function (Spirometry) dyspnea (Modified Medical Research Council Dyspnea scale) (MMRC)), and fatigue (Fatigue Severity scale (FSS)) were evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients with pacemakers | – | –Functional (6-Minute Walking test (6-MWT)) and maximal exercise capacity (Incremental Shuttle Walking test (ISWT)), respiratory (MIP, MEP; Mouth pressure device) and peripheral muscle strength (Dynamometer), pulmonary function (Spirometry) dyspnea (Modified Medical Research Council Dyspnea scale) (MMRC)), and fatigue (Fatigue Severity scale (FSS)) were evaluated in 50 patients. |
| Healthy controls | – | –Healthy individuals (n=40) were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prior to evaluation, all patients' clinical evaluation and echocardiographic measurements and pacemaker routine controls were conducted by a cardiologist. All patients and controls were tested by a physical therapist. Demographic characteristics were recorded. Functional and maximal exercise capacity, respiratory and peripheral muscle strength, pulmonary function, dyspnea and fatigue perception were evaluated and compared with age- and gender-matched healthy controls (without any chronic diseases) who volunteered to participate to the study.
Key inclusion criteria (5 listed)
- Heart failure patients with ischemic or non-ischemic etiology,
- Aged between 18 and 80 years,
- Being clinically stable for at least 4 weeks,
- Having any type of implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT), New York Heart Association (NYHA) Class II-III,
- Having no change in medications over three months and all comorbid conditions, such as hypertension and diabetes, controlled.
Key exclusion criteria (3 listed)
- Having acute myocardial infarction, cognitive disorders, complex arrhythmias, uncontrolled hypertension, stroke or transient ischemic attack within the last six months prior to the study, angina pectoris, recent viral infections (six months prior to study), significant valvular disease,
- Having history of malignancy,
- Having orthopedic problems and rheumatologic diseases.
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
submaximal exercise capacity evaluation
Time frame: 8-10 minutes
The six-minute walking test (6-MWT) was used to evaluate submaximal exercise capacity.
6 secondary outcomes
pulmonary function test
Time frame: 5 minutes
inspiratory and expiratory muscle strength (MIP, MEP)
Time frame: 5-10 minutes
peripheral muscle strength
Time frame: 10 minutes
fatigue severity
Time frame: 1-3 minutes
Dyspnea severity
Time frame: 2 minutes
maximal exercise capacity evaluation
Time frame: 10-15 minutes
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 10 Oct 2018.
- Background: PubMed 16194620Jonsdottir S, Andersen KK, Sigurosson AF, Sigurosson SB. The effect of physical training in chronic heart failure. Eur J Heart Fail. 2006 Jan;8(1):97-101. doi: 10.1016/j.ejheart.2005.05.002. Epub 2005 Sep 27.
- Background: PubMed 16159969Clark AL. Origin of symptoms in chronic heart failure. Heart. 2006 Jan;92(1):12-6. doi: 10.1136/hrt.2005.066886. Epub 2005 Sep 13.
- Background: PubMed 8088269Volterrani M, Clark AL, Ludman PF, Swan JW, Adamopoulos S, Piepoli M, Coats AJ. Predictors of exercise capacity in chronic heart failure. Eur Heart J. 1994 Jun;15(6):801-9. doi: 10.1093/oxfordjournals.eurheartj.a060588.
- Background: PubMed 1993126Buller NP, Jones D, Poole-Wilson PA. Direct measurement of skeletal muscle fatigue in patients with chronic heart failure. Br Heart J. 1991 Jan;65(1):20-4. doi: 10.1136/hrt.65.1.20.
- Background: PubMed 1516203Minotti JR, Pillay P, Chang L, Wells L, Massie BM. Neurophysiological assessment of skeletal muscle fatigue in patients with congestive heart failure. Circulation. 1992 Sep;86(3):903-8. doi: 10.1161/01.cir.86.3.903.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.
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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.
Meral Boşnak Güçlü, PhD study director
Gazi University
Gülşah Barğı, PhD study chair
Gazi University
Nihan Katayıfçı, MsC study chair
Mustafa Kemal Üniversitesi Fizik Tedavi ve Rehabilitasyon Yüksekokulu Fizyoterapi ve Rehabilitasyon Bölümü
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure Patients, run by Gazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 10 Oct 2018. 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 Turkey (Türkiye). 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 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?
submaximal exercise capacity evaluation (time frame: 8-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701854, which also lists 5 linked publications.
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 10 Oct 2018.