Effects of IMT on Cardiac Resynchronization Therapy

NCT07035340 | Completed

• 1 other identifier: 2024/42
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Resynchronization Therapy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• NT-proBNP

  NT-proBNP

  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.

  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.

  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

  enrollment and end of the 12 week treatment

Secondary Outcomes (2)

• Respiratory muscle strength

  enrollment and end of the first week of treatment

• The performance of patients' activities of daily living

  at enrollment and end of the 12 week treatment

Study Arms (2)

İntervention group

EXPERIMENTAL

inspiratory muscle training

Other: inspiratory muscle training

Control group

OTHER

Standart care

Other: standart care

Interventions

inspiratory muscle training OTHER

inspiratory muscle traning MIP%40-60

İntervention group

standart care OTHER

standart care

Control group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• years old,
• communicate in Turkish,
• NYHA II-III

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, Mersin, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Doctor who doing ekogardiography.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd,PT

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 25, 2025
• Study Start: May 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)