Clinical trial NCT03501355: Effects of Inspiratory Muscle and Endurance Training in Heart Failure Patients With Pacemaker
Official title: Effects of Inspiratory Muscle and Endurance Training on Exercise Capacity, Respiratory Muscle Strength and Endurance and Quality of Life in Heart Failure Patients With Pacemaker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker
Keywords: pacemaker
inspiratory muscle training
exercise capacity
Quality of Life
Respiratory Muscle Strength
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is well-known that not only peripheral muscles, but also respiratory muscles muscle weakness and deconditioning play an important role in low exercise capacity of patients with Heart Failure (HF). Exercise training has been shown to improve exercise tolerance and quality of life in patients with heart disease. However, hearth failure patients with pacemaker such as implantable cardioverter defibrillators (ICDs), cardiac resynchronization pacemakers or defibrillators (CRT-P or CRT-D) have additional specific issues when performing exercise. No study investigated the effects of different inspiratory muscle training protocols. For this reason, we aimed to investigate the effects of inspiratory muscle training on outcomes in hearth failure patients with pacemaker

Detailed description: Heart failure patients with pacemaker will be included. Primary outcome measurement is respiratory muscle strength, secondary outcomes are functional exercise capacity, peripheral muscle strength, pulmonary functions, maximal exercise capacity, fatigue, quality of life, depression, physical activity.

Eligibility criteria: Inclusion Criteria:

* Heart failure patients with Pacemaker who are clinically stable
* After 12 weeks of pacemaker implantation
* No change in medications over one month

Exclusion Criteria:

Patients with

* Severe cognitive disorders
* Pulmonary, neurological and orthopedic diseases
* Pregnant and lactating patients
* Acute infection or exacerbation

Primary outcomes:
measure: Maximal Exercise capacity
timeFrame: First day
Secondary outcomes:
measure: Inspiratory and expiratory muscle strength (MIP, MEP)
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: First day
measure: Pulmonary functions
timeFrame: First day
measure: Fatigue
timeFrame: Second day
measure: Quality of life
timeFrame: Second day
measure: Depression
timeFrame: Second day
measure: Physical activity
timeFrame: Second day
measure: Health-related quality of life
timeFrame: Second day
measure: Cognitive function
timeFrame: First day
measure: Functional exercise capacity
timeFrame: Second day
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Mustafa Kemal University
Study officials:
affiliation: Gazi University Faculty of Health Science Department of Physical Therapy and Rehabilitation
name: Meral Boşnak-Güçlü, PhD
role: STUDY_DIRECTOR
affiliation: Mustafa Kemal University School of Physical Therapy and Rehabilitation
name: Nihan Katayıfçı, MSc
role: STUDY_CHAIR
affiliation: Mustafa Kemal University
name: Fatih Şen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alswyan AH, Liberato ACS, Dougherty CM. A Systematic Review of Exercise Training in Patients With Cardiac Implantable Devices. J Cardiopulm Rehabil Prev. 2018 Mar;38(2):70-84. doi: 10.1097/HCR.0000000000000289.
citation: Belardinelli R, Capestro F, Misiani A, Scipione P, Georgiou D. Moderate exercise training improves functional capacity, quality of life, and endothelium-dependent vasodilation in chronic heart failure patients with implantable cardioverter defibrillators and cardiac resynchronization therapy. Eur J Cardiovasc Prev Rehabil. 2006 Oct;13(5):818-25. doi: 10.1097/01.hjr.0000230104.93771.7d.
citation: Dougherty CM, Glenny RW, Burr RL, Flo GL, Kudenchuk PJ. Prospective randomized trial of moderately strenuous aerobic exercise after an implantable cardioverter defibrillator. Circulation. 2015 May 26;131(21):1835-42. doi: 10.1161/CIRCULATIONAHA.114.014444. Epub 2015 Mar 19.
citation: Isaksen K, Munk PS, Giske R, Larsen AI. Effects of aerobic interval training on measures of anxiety, depression and quality of life in patients with ischaemic heart failure and an implantable cardioverter defibrillator: A prospective non-randomized trial. J Rehabil Med. 2016 Mar;48(3):300-6. doi: 10.2340/16501977-2043.
citation: Katayifci N, Bosnak Guclu M, Sen F. A comparison of the effects of inspiratory muscle strength and endurance training on exercise capacity, respiratory muscle strength and endurance, and quality of life in pacemaker patients with heart failure: A randomized study. Heart Lung. 2022 Sep-Oct;55:49-58. doi: 10.1016/j.hrtlng.2022.04.006. Epub 2022 Apr 23.