NCT04839211

Brief Summary

The aim of this study is to investigate the potential effects of inspiratory muscle training on cardiovascular, respiratory, physical, and psychosocial functions in patients with heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

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 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 3, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

April 6, 2021

Last Update Submit

November 21, 2022

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Heart rate variability

    Heart rate variability analysis, which gives information about the cardiac autonomic function, will be obtained from a short-term 5-min ECG recording using a SphygmoCor device.

    change from baseline to 8 weeks

  • Arterial stiffness

    Arterial stiffness will be measured using a SphygmoCor device.

    change from baseline to 8 weeks

Secondary Outcomes (16)

  • Maximal inspiratory pressure

    change from baseline to 8 weeks

  • Maximal expiratory pressure

    change from baseline to 8 weeks

  • Respiratory muscle endurance

    change from baseline to 8 weeks

  • Forced vital capacity (FVC)

    change from baseline to 8 weeks

  • Forced expiratory volume in 1 second (FEV1)

    change from baseline to 8 weeks

  • +11 more secondary outcomes

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL

High-intensity interval-based inspiratory muscle training

Device: Inspiratory muscle training

Sham inspiratory muscle training

SHAM COMPARATOR

Unloaded inspiratory muscle training

Device: Sham inspiratory muscle training

Interventions

Inspiratory muscle trainingDEVICE

Inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the highest tolerable load and will be gradually increased.

Inspiratory muscle training
Sham inspiratory muscle trainingDEVICE

Sham inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the unloaded.

Sham inspiratory muscle training

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of heart failure with reduced ejection fraction
  • Clinically stable
  • Functional class II-III according to the New York Heart Association functional classification
  • Having inspiratory muscle weakness (MIP\<70%)
  • Volunteer to participation

You may not qualify if:

  • Congenital heart disease
  • Severe valvular heart disease
  • Cardiac device such as implantable cardioverter defibrillator or cardiac resynchronization therapy
  • Neurological disease
  • Conditions that may limit the physical mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

  • Tanriverdi A, Savci S, Ozcan Kahraman B, Odaman H, Ozpelit E, Senturk B, Ozsoy I, Baran A, Akdeniz B, Acar S, Balci A. Effects of high intensity interval-based inspiratory muscle training in patients with heart failure: A single-blind randomized controlled trial. Heart Lung. 2023 Nov-Dec;62:1-8. doi: 10.1016/j.hrtlng.2023.05.011. Epub 2023 Jun 7.

    PMID: 37285766DERIVED

Study Officials

  • Sema Savci

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 9, 2021

Study Start

June 3, 2021

Primary Completion

November 21, 2022

Study Completion

November 21, 2022

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)