NCT03501355

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

April 10, 2018

Last Update Submit

July 2, 2021

Conditions

Pacemaker

Keywords

pacemakerinspiratory muscle trainingexercise capacityQuality of LifeRespiratory Muscle Strength

Outcome Measures

Primary Outcomes (1)

  • Maximal Exercise capacity

    Incremental Shuttle Walk Test

    First day

Secondary Outcomes (10)

  • Inspiratory and expiratory muscle strength (MIP, MEP)

    First day

  • Peripheral muscle strength

    First day

  • Pulmonary functions

    First day

  • Fatigue

    Second day

  • Quality of life

    Second day

  • +5 more secondary outcomes

Study Arms (2)

Strength training group

ACTIVE COMPARATOR

Intervention:Inspiratory muscle strength training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device

Device: Inspiratory muscle strength training

Endurance training group

ACTIVE COMPARATOR

Intervention: Inspiratory muscle endurance training group received inspiratory muscle endurance training (IMT) using POWERbreathe Classic threshold loading device

Device: Inspiratory muscle endurance training

Interventions

Inspiratory muscle strength trainingDEVICE

Treatment group will receive inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 50% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 50% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.

Strength training group
Inspiratory muscle endurance trainingDEVICE

Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.

Endurance training group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal University

Hatay, 31135, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 29465496BACKGROUND

  • 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.

    PMID: 17001224BACKGROUND

  • 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.

    PMID: 25792557BACKGROUND

  • 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.

    PMID: 26667151BACKGROUND

  • 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.

    PMID: 35472660DERIVED

Study Officials

  • Meral Boşnak-Güçlü, PhD

    Gazi University Faculty of Health Science Department of Physical Therapy and Rehabilitation

    STUDY DIRECTOR

  • Nihan Katayıfçı, MSc

    Mustafa Kemal University School of Physical Therapy and Rehabilitation

    STUDY CHAIR

  • Fatih Şen, PhD

    Mustafa Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Study Start

April 20, 2018

Primary Completion

May 30, 2019

Study Completion

September 30, 2019

Last Updated

July 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)