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Clinical Trials/NCT03501355
NCT03501355
Completed
N/A

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

Gazi University1 site in 1 country30 target enrollmentApril 20, 2018
ConditionsPacemaker

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pacemaker
Sponsor
Gazi University
Enrollment
30
Locations
1
Primary Endpoint
Maximal Exercise capacity
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2018
End Date
September 30, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Assoc. Prof

Gazi University

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

Outcomes

Primary Outcomes

Maximal Exercise capacity

Time Frame: First day

Incremental Shuttle Walk Test

Secondary Outcomes

  • Peripheral muscle strength(First day)
  • Inspiratory and expiratory muscle strength (MIP, MEP)(First day)
  • Pulmonary functions(First day)
  • Depression(Second day)
  • Fatigue(Second day)
  • Quality of life(Second day)
  • Health-related quality of life(Second day)
  • Functional exercise capacity(Second day)
  • Physical activity(Second day)
  • Cognitive function(First day)

Study Sites (1)

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