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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| submaximal exercise capacity evaluation | The six-minute walking test (6-MWT) was used to evaluate submaximal exercise capacity. | 8-10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary function test | This test was evaluated using a spirometry by which is evaluated dynamic lung functions expressed as percentages of expected values. | 5 minutes |
| inspiratory and expiratory muscle strength (MIP, MEP) |
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Inclusion criteria:
Exclusion criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Meral Boşnak Güçlü, PhD | Gazi University | Study Director |
| Gülşah Barğı, PhD | Gazi University | Study Chair |
| Nihan Katayıfçı, MsC | Mustafa Kemal Üniversitesi Fizik Tedavi ve Rehabilitasyon Yüksekokulu Fizyoterapi ve Rehabilitasyon Bölümü | Study Chair |
| Fatih Şen, PhD. | Mustafa Kemal Üniversitesi Tayfur Ata Sökmen Tıp Fakültesi Kardiyoloji Anabilim Dalı | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University Faculty of Health Science Department of PhysioTherapy | Ankara | 06560 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16194620 | Background | 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. | |
| 16159969 | Background | Clark 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. |
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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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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004417 | Dyspnea |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Respiratory muscle strength was evaluated with a mouth pressure device
| 5-10 minutes |
| peripheral muscle strength | Peripheral muscle strength was evaluated with a hand-held dynamometer | 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. | 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. | 2 minutes |
| maximal exercise capacity evaluation | and the incremental shuttle walk test (ISWT) was used to evaluate submaximal exercise capacity. | 10-15 minutes |
| 8088269 | Background | Volterrani 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. |
| 1993126 | Background | Buller 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. |
| 1516203 | Background | Minotti 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. |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |