Skip to content

Effects of IMT on Cardiac Resynchronization Therapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07035340
Acronym
CRT-IMT
Enrollment
32
Registered
2025-06-25
Start date
2024-05-15
Completion date
2025-06-15
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Resynchronization Therapy

Keywords

inspiratory muscle training, cardiac resynchronization therapy, exercises capacity, quality of life

Brief summary

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?

Interventions

OTHERinspiratory muscle training

inspiratory muscle traning MIP%40-60

standart care

Sponsors

Tarsus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Doctor who doing ekogardiography.

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
NT-proBNPenrollment and end of the 12 week treatmentNT-proBNP
Exercises capacityenrollment and end of the first week of treatmentExercise capacity was evaluated using the 6-minute walk test (6MWT). 6MWT was performed according to the ATS/ERS criteria.
Heart rate (Exercises capacity)enrollment and end of the first week of treatmentHeart rate were measured using a portable pulse oximeter (Cosmed Srl, Cosmed Spiropalm, Rome, Italy), before, after and 1 minute recovery.
Quality of Life of patientsenrollment and end of the 12 week treatmentQality 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

MeasureTime frameDescription
Respiratory muscle strengthenrollment and end of the first week of treatmentRespiratory 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
The performance of patients' activities of daily livingat enrollment and end of the 12 week treatmentThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026