Physical Impairments in Heart Failure Patients With Pacemakers

NCT03701854 | Completed

• 1 other identifier: GaziUniversity16
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure Patients

Keywords

heart failure; pacemaker; exercise test; muscle strength; dyspnea; fatigue

Outcome Measures

Primary Outcomes (1)

• submaximal exercise capacity evaluation

  The six-minute walking test (6-MWT) was used to evaluate submaximal exercise capacity.

  8-10 minutes

Secondary Outcomes (6)

• pulmonary function test

  5 minutes

• inspiratory and expiratory muscle strength (MIP, MEP)

  5-10 minutes

• peripheral muscle strength

  10 minutes

• fatigue severity

  1-3 minutes

• Dyspnea severity

  2 minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Science Department of PhysioTherapy

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 16194620 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.

  PMID: 16159969 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.

  PMID: 8088269 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.

  PMID: 1993126 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.

  PMID: 1516203 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Dyspnea; Fatigue

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 10, 2018
• Study Start: January 1, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)