Skip to main content
OpenTrials
Completed

NCT Number: NCT07035340

Effects of IMT on Cardiac Resynchronization Therapy

Patients who are followed up in the cardiology clinic with a diagnosis of CHF, who have had a CRT implant at least 1 year ago, and who do not receive cardiac rehabilitation will be included. The aim of the study is to investigate the effects of inspiratory muscle training (IMT) on exercise capacity, respiratory muscle strength, NTproBNP and quality of life.

Groups Intervention group: Treatment with IMT Control group: Standard care Study hypothesis;

1. Does IMT have an effect on exercise capacity and quality of life in patients with CRT? 2. Does IMT have an effect on NTproBNP in patients with CRT?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Resynchronization Therapy

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus University

Mersin, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who were followed up in the cardiology clinic with a diagnosis of CHF,
  • CRT implanted at least 1 year ago,
  • did not receive cardiac rehabilitation,
  • 45-75 years old,
  • communicate in Turkish,
  • NYHA II-III

Exclusion criteria

  • orthopedic and neurological disorders that may prevent walking,
  • acute respiratory tract infection in the last month,
  • NYHA I were not included in this study because they were generally not hospitalised and the problems were managed with outpatient diagnosis and treatment, and patients with class IV were not included in this study because they showed severe symptoms for medical and ethical reasons and they were not wanted to be forced with this long-lasting survey application process.

Treatment and study plan

Inspiratory Muscle Training

Other

inspiratory muscle traning MIP%40-60

standart care

Other

standart care

Primary outcomes

  1. NT-proBNP

    Time frame: enrollment and end of the 12 week treatment

    NT-proBNP

  2. Exercises capacity

    Time frame: enrollment and end of the first week of treatment

    Exercise capacity was evaluated using the 6-minute walk test (6MWT). 6MWT was performed according to the ATS/ERS criteria.

  3. Heart rate (Exercises capacity)

    Time frame: enrollment and end of the first week of treatment

    Heart rate were measured using a portable pulse oximeter (Cosmed Srl, Cosmed Spiropalm, Rome, Italy), before, after and 1 minute recovery.

  4. Quality of Life of patients

    Time frame: enrollment and end of the 12 week treatment

    Qality of life was assessed using the Nottingham Health Profile (NHP) self-reported tool. The NHP questionnaire evaluates six dimensions of health (pain, energy level, sleep, physical abilities, emotional reaction and social isolation) and includes 38 items. Total NHP score ranges between 0-600 and quality of life perception is negatively associated with score received

Secondary outcomes

  1. Respiratory muscle strength

    Time frame: enrollment and end of the first week of treatment

    Respiratory muscle strength was measured with a portable, electronic mouth pressure measuring device (Micro Medical Micro RPM, Rochester, UK). Three measurements were made to obtain the best value. There should not be more than a 10% difference between the two best-measured values. Actual MIP values and percentages of expected values according to age and gender were used in the analysis

  2. The performance of patients' activities of daily living

    Time frame: at enrollment and end of the 12 week treatment

    The performance of patients' activities of daily living was assessed with the Performance Measurement of Activities of Daily Living Questionnaire-8 (PMDL-8), the Turkish validity and reliability of which was performed by Ertürk et al. The PMADL-8 questionnaire for Patients with Congestive Heart Failure assesses functional limitations in CHF patients based on the ICF model. High scores indicate severe functional limitations.

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Registry information

Official study title

EFFECTS OF INSPIRATION MUSCLE TRAINING ON NT-PROBNP, FUNCTIONAL EXERCISE CAPACITY, DAILY LIVING EXERCISE PERFORMANCE, AND QUALITY OF LIFE IN PATIENTS UNDERGOING CARDIAC RESYNCHRONIZATION THERAPY

Acronym: CRT-IMT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.