NCT04834336

Brief Summary

Hospitalized patients with acute decompensated heart failure (ADHF) present a high prevalence of inspiratory muscle weakness on admission and discharge. Inspiratory muscle training has been reported as a beneficial approach in chronic heart failure. However, the effects of inspiratory muscle training in hospitalized patients with ADHF have been not known. The aim of this study is to investigate the safety, feasibility, and effects of inspiratory muscle training in hospitalized patients with ADHF.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Status
unknown

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 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

April 1, 2021

Last Update Submit

October 30, 2022

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Maximal Inspiratory Pressure

    Maximal inspiratory pressure will be measured by an electronic mouth pressure device (cmH2O)

    baseline and hospital discharge, an average of 4 to 10 days

Secondary Outcomes (13)

  • Adverse events

    During the hospitalization, daily, during an average of 4 to 10 days

  • Recruitment rate

    During the hospitalization, daily, during an average of 4 to 10 days

  • Adherence rate

    During the hospitalization, daily, during an average of 4 to 10 days

  • Retention rate

    During the hospitalization, daily, during an average of 4 to 10 days

  • New York Heart Association Functional Classification

    baseline and hospital discharge, an average of 4 to 10 days

  • +8 more secondary outcomes

Study Arms (2)

Physical training plus inspiratory muscle training

EXPERIMENTAL

Inspiratory Muscle Training (IMT) will be implemented by using the Power Breathe® device. IMT training will begin with mild to moderate intensity of maximal inspiratory pressure. It will be performed 6 to 10 breaths, 4 sets, and twice daily during the hospitalization when as soon as hemodynamic stability is provided. Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided.

Device: inspiratory muscle training deviceOther: Physical training

Physical training

ACTIVE COMPARATOR

Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided.

Other: Physical training

Interventions

inspiratory muscle training deviceDEVICE

Inspiratory muscle training will be performed with an inspiratory muscle training device.

Physical training plus inspiratory muscle training
Physical trainingOTHER

Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.

Physical trainingPhysical training plus inspiratory muscle training

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The management of a diagnosis of ADHF over 24 hours in a hospital setting
  • Hemodynamic stability
  • The independence of basic activities of daily life before admission

You may not qualify if:

  • Acute myocardial infarction
  • Congenital heart disease
  • Endocarditis, miyocarditis or pericarditis
  • Morbid obesity
  • Already participating in cardiac rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Physical Conditioning, Human

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sema Savci, Prof

    Dokuz Eylul University

    STUDY DIRECTOR

Central Study Contacts

Aylin Tanriverdi

CONTACT

+905352359989tanrverdiaylin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 8, 2021

Study Start

January 15, 2023

Primary Completion

April 1, 2023

Study Completion

April 1, 2024

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share