Clinical trial NCT03923153: Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
Official title: Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina, Stable
Keywords: inspiratory muscle trainig
quality of life
aerobic capacity
depression
fatique
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Stable angina is a cardiac pathology that adversely affects the quality of life of the patient, which develops as a result of narrowing of the coronary vessels developing in atherosclerotic ground and / or impaired oxygen supply-need balance. Studies widely investigated the effects of exercise training in patients with stable angina. No study investigated the effects of inspiratory muscle training in patients with stable angina.Investigators aimed to investigate the effects of inspiratory muscle training on aerobic exercise capacity, quality of life, depression, peripheral and respiratory (MIP, MEP) muscle strength, pulmonary function, dyspnea, fatigue in stable angina patients.

Detailed description: Patients with stable angina will be included. Primary outcome measurement is inspiratory muscle strength, secondary outcomes are functional exercise capacity, peripheral muscle strength, pulmonary functions, maximal exercise capacity, fatigue, quality of life, depression.

Eligibility criteria: Inclusion Criteria:

* No contraindication for pulmonary physiotherapy
* Anjina patients who are clinically stable
* have no other disease that may affect respiratory function
* Individuals who have the good cooperation

Exclusion Criteria:

* Patients under the age of 18
* Pregnancy
* Active infection
* Patients with known malignancies
* patients without consent
* known arrhythmia, dilated or hypertrophic cardiomyopathy, heart failure (EF \<40%)

Primary outcomes:
measure: Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week
timeFrame: Baseline, after 8 week
Secondary outcomes:
measure: Change from Baseline Functional exercise capacity at 8 week
timeFrame: Baseline, after 8 week
measure: Change from Pulmonary functions at 8 week
timeFrame: Baseline, after 8 week
measure: Fatigue
timeFrame: Baseline, after 8 week
measure: Depression
timeFrame: Baseline,after 8 week
Other outcomes:
measure: Quality life
timeFrame: Baseline, after 8 week
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
state: Merkez
Study officials:
affiliation: Marmara University Faculty of Health Sciences
name: Aysel yıldız, assoc prof
role: STUDY_DIRECTOR
affiliation: Mustafa Kemal University
name: Irem Hüzmeli, Msc
role: STUDY_CHAIR
affiliation: hatay mustafa kemal university Faculty of Medicine
name: Oğuz Akkuş, assist prof
role: PRINCIPAL_INVESTIGATOR
affiliation: hatay mustafa kemal university Faculty of Medicine
name: Fatih Yalçın, Prof.
role: STUDY_CHAIR
References:
citation: Kellens I, Cannizzaro F, Gouilly P, Crielaard JM. [Inspiratory muscles strength training in recreational athletes]. Rev Mal Respir. 2011 May;28(5):602-8. doi: 10.1016/j.rmr.2011.01.008. Epub 2011 Apr 19. French.
citation: Long L, Anderson L, Dewhirst AM, He J, Bridges C, Gandhi M, Taylor RS. Exercise-based cardiac rehabilitation for adults with stable angina. Cochrane Database Syst Rev. 2018 Feb 2;2(2):CD012786. doi: 10.1002/14651858.CD012786.pub2.
citation: American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.