Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Angina, Stable Clinical Trial

Official title:

Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923153
• Other study ID #: MustafaKU 2
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: May 2021
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Respiratory Aspiration

Intervention

Device:
• Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.
• Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)
Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 10% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University	Hatay	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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:CD012786. doi: 10.1002/14651858.CD012786.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality life	Change of baseline quality of life at 8 week .Short Form (SF-36) Health Survey (Turkish version of scale) The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health: physical functioning (10 items) social functioning (2 items) role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general health perception (5 items). For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).	Baseline, after 8 week
Primary	Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week	Mouth pressure device( MicroRPM, Micro Medical England)	Baseline, after 8 week
Secondary	Change from Baseline Functional exercise capacity at 8 week	6 minute walking test	Baseline, after 8 week
Secondary	Change from Pulmonary functions at 8 week	Spirometry	Baseline, after 8 week
Secondary	Fatigue	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	Baseline, after 8 week
Secondary	Depression	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.	Baseline,after 8 week