Effects of IMT on Cardiac Resynchronization Therapy

Tarsus University32 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Resynchronization Therapy

Interventions

inspiratory muscle trainingOTHER

inspiratory muscle traning MIP%40-60

standart careOTHER

standart care

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tarsus University

Mersin, Mersin, Turkey (Türkiye)

Outcomes

Primary Outcomes

NT-proBNP

Time frame: enrollment and end of the 12 week treatment

Exercises capacity

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

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

Heart rate (Exercises capacity)

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

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

Quality of Life of patients

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

Time frame: enrollment and end of the 12 week treatment

Secondary Outcomes

Respiratory muscle strength

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

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

The performance of patients' activities of daily living

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.

Data from ClinicalTrials.gov

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