Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-29
Brief Title:
Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises in Hypertrophic Cardiomyopathy Patients
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises on Pulmonary Function Exercise Capacity and Quality of Life in Patients With Hypertrophic Cardiomyopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to compare the effects of inspiratory muscle training and Baduanjin exercises on pulmonary function exercise capacity and quality of life in patients with hypertrophic cardiomyopathy By investigating these interventions the investigators seek to introduce novel approaches that can enhance pulmonary function exercise capacity and overall quality of life for these patients
In the study which will involve three groups-the control group the inspiratory muscle training IMT group and the Baduanjin group-it was calculated that a total of 51 patients with 17 in each group n 17 should be included
The IMT group will use an inspiratory muscle training device twice a day every day of the week for 15 minutes This training will continue for 8 weeks with supervision once a week and unsupervised sessions on the other days
The Baduanjin group will participate in a 50-minute exercise program which includes a 10-minute warm-up a 30-minute routine of eight separate movements and a 10-minute cool-down This will occur three times a week twice in person and once online for 8 weeks
In the study which will involve three groups-the control group the inspiratory muscle training IMT group and the Baduanjin group-it was calculated that a total of 51 patients with 17 in each group n 17 should be included
The IMT group will use an inspiratory muscle training device twice a day every day of the week for 15 minutes This training will continue for 8 weeks with supervision once a week and unsupervised sessions on the other days
The Baduanjin group will participate in a 50-minute exercise program which includes a 10-minute warm-up a 30-minute routine of eight separate movements and a 10-minute cool-down This will occur three times a week twice in person and once online for 8 weeks
Detailed Description:
Hypertrophic cardiomyopathy HCM is characterized by a left ventricular wall thickness exceeding 15 millimeters mm as assessed by echocardiography and cardiac magnetic resonance imaging MRI It is a common genetic heart disease worldwide known to cause left ventricular outflow tract obstruction mitral regurgitation diastolic dysfunction myocardial ischemia arrhythmias and autonomic dysfunction PubMed identification number ID 29655825 28912181 24998133 30110588 33229115
Many patients with HCM are asymptomatic and the condition is often identified incidentally during routine screening Symptomatic patients may experience dyspnea on exertion chest pain syncope or presyncope PubMed ID11886323 Even when left ventricular systolic function is preserved patients frequently develop symptoms such as dyspnea and fatigue leading to exercise intolerance in the majority PubMed ID10913477
HCM is a heterogeneous disease with a varied clinical course In addition to these symptoms patients may also face decreased exercise capacity and reduced quality of life PubMed ID19253387 9326995 Furthermore despite the well-established cardiovascular and overall health benefits of regular physical activity many patients with HCM exhibit a high prevalence of physical inactivity PubMed ID 23340032 27547438
Studies on inspiratory muscle training have demonstrated its benefits in improving respiratory function respiratory muscle strength quality of life and exercise capacity across various patient groups including chronic obstructive pulmonary disease cystic fibrosis spinal cord injury and heart failure It also helps alleviate symptoms of dyspnea and fatigue PubMed ID32209709 30827470 32936904 31429207 31937553 Additionally inspiratory muscle training has been shown to enhance physical activity levels in different patient cohorts PubMed ID 17534784
Research indicates that Baduanjin exercises can serve as a complementary and alternative treatment for cardiovascular patients improving clinical outcomes and reducing adverse cardiovascular events PubMed ID30059552 Furthermore studies have highlighted their positive effects on quality of life and exercise capacity in diverse populations such as healthy individuals and those with conditions like heart failure Parkinsons disease osteoarthritis and chronic fatigue syndrome while also mitigating fatigue symptoms PubMed ID 36436262 19051349 27627031 23001463 18315512 26083663 25610473 27938498
Based on existing literature the investigators believe that inspiratory muscle training and Baduanjin exercises could potentially benefit patients with HCM by alleviating associated symptoms However there is a notable scarcity of studies investigating different exercise modalities in HCM patients To the investigators knowledge no studies have specifically examined the effects of inspiratory muscle training or Baduanjin exercises in this population
The study aims to fill this gap by being the first to compare the impacts of inspiratory muscle training and Baduanjin exercises on pulmonary function exercise capacity and quality of life in patients with HCM Through this research the investigators seek to introduce new approaches that enhance pulmonary function exercise capacity and overall quality of life for these patients
Many patients with HCM are asymptomatic and the condition is often identified incidentally during routine screening Symptomatic patients may experience dyspnea on exertion chest pain syncope or presyncope PubMed ID11886323 Even when left ventricular systolic function is preserved patients frequently develop symptoms such as dyspnea and fatigue leading to exercise intolerance in the majority PubMed ID10913477
HCM is a heterogeneous disease with a varied clinical course In addition to these symptoms patients may also face decreased exercise capacity and reduced quality of life PubMed ID19253387 9326995 Furthermore despite the well-established cardiovascular and overall health benefits of regular physical activity many patients with HCM exhibit a high prevalence of physical inactivity PubMed ID 23340032 27547438
Studies on inspiratory muscle training have demonstrated its benefits in improving respiratory function respiratory muscle strength quality of life and exercise capacity across various patient groups including chronic obstructive pulmonary disease cystic fibrosis spinal cord injury and heart failure It also helps alleviate symptoms of dyspnea and fatigue PubMed ID32209709 30827470 32936904 31429207 31937553 Additionally inspiratory muscle training has been shown to enhance physical activity levels in different patient cohorts PubMed ID 17534784
Research indicates that Baduanjin exercises can serve as a complementary and alternative treatment for cardiovascular patients improving clinical outcomes and reducing adverse cardiovascular events PubMed ID30059552 Furthermore studies have highlighted their positive effects on quality of life and exercise capacity in diverse populations such as healthy individuals and those with conditions like heart failure Parkinsons disease osteoarthritis and chronic fatigue syndrome while also mitigating fatigue symptoms PubMed ID 36436262 19051349 27627031 23001463 18315512 26083663 25610473 27938498
Based on existing literature the investigators believe that inspiratory muscle training and Baduanjin exercises could potentially benefit patients with HCM by alleviating associated symptoms However there is a notable scarcity of studies investigating different exercise modalities in HCM patients To the investigators knowledge no studies have specifically examined the effects of inspiratory muscle training or Baduanjin exercises in this population
The study aims to fill this gap by being the first to compare the impacts of inspiratory muscle training and Baduanjin exercises on pulmonary function exercise capacity and quality of life in patients with HCM Through this research the investigators seek to introduce new approaches that enhance pulmonary function exercise capacity and overall quality of life for these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None