Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

• ClinicalTrials.gov Identifier: NCT03923153
• Recruitment Status: Completed
• First Posted: April 22, 2019
• Last Update Posted: May 6, 2021
• Sponsor: Mustafa Kemal University
• Information provided by (Responsible Party): Irem Hüzmeli, Mustafa Kemal University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Angina, Stable	Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England); Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina
• Actual Study Start Date: April 15, 2019
• Actual Primary Completion Date: August 30, 2020
• Actual Study Completion Date: August 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Inspiratory muscle training group; Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device	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 Comparator: Sham group; Sham group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 week [ Time Frame: Baseline, after 8 week ]
   Mouth pressure device( MicroRPM, Micro Medical England)

Secondary Outcome Measures :

1. Change from Baseline Functional exercise capacity at 8 week [ Time Frame: Baseline, after 8 week ]
   6 minute walking test
2. Change from Pulmonary functions at 8 week [ Time Frame: Baseline, after 8 week ]
   Spirometry
3. Fatigue [ Time Frame: 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

4. Depression [ Time Frame: 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.

Other Outcome Measures:

1. Quality life [ Time Frame: Baseline, after 8 week ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%)

Contacts and Locations

Locations

Turkey

Hatay Mustafa Kemal University

Hatay, Merkez, Turkey, 31010

Sponsors and Collaborators

Mustafa Kemal University

Investigators

• Study Director: Aysel yıldız, assoc prof; Marmara University Faculty of Health Sciences
• Study Chair: Irem Hüzmeli, Msc; Mustafa Kemal University
• Principal Investigator: Oğuz Akkuş, assist prof; hatay mustafa kemal university Faculty of Medicine
• Study Chair: Fatih Yalçın, Prof.; hatay mustafa kemal university Faculty of Medicine

More Information

Publications:

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.

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.

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.

• Responsible Party: Irem Hüzmeli, lecturer, Mustafa Kemal University
• ClinicalTrials.gov Identifier: NCT03923153
• Other Study ID Numbers: MustafaKU 2
• First Posted: April 22, 2019
• Last Update Posted: May 6, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Irem Hüzmeli, Mustafa Kemal University:

inspiratory muscle trainig; quality of life; aerobic capacity; depression; fatique

Additional relevant MeSH terms:

Respiratory Aspiration; Angina Pectoris; Angina, Stable; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes