Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Not Applicable

Completed

• Conditions: Angina, Stable
• Interventions: Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England); Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)

• Registration Number: NCT03923153
• Lead Sponsor: Mustafa Kemal University

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.

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-22
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)	Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Inspiratory muscle training group	Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)	Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device

Primary Outcome Measures

Name	Time	Method
Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week	Baseline, after 8 week	Mouth pressure device( MicroRPM, Micro Medical England)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Functional exercise capacity at 8 week	Baseline, after 8 week	6 minute walking test
Change from Pulmonary functions at 8 week	Baseline, after 8 week	Spirometry
Fatigue	Baseline, after 8 week	Change from baseline Fatigue Severity Scale (FSS) (Turkish version of scale) at 8 weeek.; Patient choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue
Depression	Baseline,after 8 week	Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) (Turkish version of scale) at 8 week.; This assessment tool contains 10 items with a score from 0 to 6, thus the maximum score is 60. A higher score indicates a more severe depression.

Trial Locations

Locations (1)

Hatay Mustafa Kemal University; 🇹🇷 Hatay, Merkez, Turkey