Cardiac Resynchronization TherapyCRT-IMTNCT07035340
Effects of IMT on Cardiac Resynchronization Therapy
A study testing inspiratory muscle training and standart care in people with Cardiac Resynchronization Therapy, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cardiac Resynchronization Therapy
- What is being tested?
- inspiratory muscle training and standart care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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;
- Does IMT have an effect on exercise capacity and quality of life in patients with CRT?
- Does IMT have an effect on NTproBNP in patients with CRT?
- Conditions
- Cardiac Resynchronization Therapy
- Being tested
- inspiratory muscle training, standart care
- Keywords
- inspiratory muscle training, cardiac resynchronization therapy, exercises capacity, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
inspiratory muscle traning MIP%40-60
standart careOther
standart care
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | inspiratory muscle training Receives: Other: inspiratory muscle training |
| Control group | Other | Standart care Receives: Other: standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP
NT-proBNP
Measured: 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.
Measured: 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.
Measured: 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
Measured: enrollment and end of the 12 week treatment
Secondary outcomes (2)
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
Measured: 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.
Measured: at enrollment and end of the 12 week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 May 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurel Ertürk, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035340
- Sponsor's protocol ID
- 2024/42
- Acronym
- CRT-IMT
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07035340
- Acronym / sponsor ID
- CRT-IMT / 2024/42
- Conditions
- Cardiac Resynchronization Therapy
- Keywords
- inspiratory muscle training, cardiac resynchronization therapy, exercises capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Does IMT have an effect on exercise capacity and quality of life in patients with CRT?
- Does IMT have an effect on NTproBNP in patients with CRT?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Other: inspiratory muscle traininginspiratory muscle training |
| Control group | Other | Other: standart careStandart care |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle traininginspiratory muscle traning MIP%40-60 | Other | İntervention group |
| standart carestandart care | Other | Control group |
Primary outcome
NT-proBNP
Time frame: enrollment and end of the 12 week treatment
NT-proBNP
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.
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.
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
2 secondary outcomes
Respiratory muscle strength
Time frame: enrollment and end of the first week of treatment
The performance of patients' activities of daily living
Time frame: at enrollment and end of the 12 week treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training and standart care in people with Cardiac Resynchronization Therapy, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP (time frame: enrollment and end of the 12 week treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.