Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

May 5, 2021 updated by: Irem Hüzmeli, Mustafa Kemal University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Hatay, Merkez, Turkey, 31010
        • Hatay Mustafa Kemal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, after 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Functional exercise capacity at 8 week
Time Frame: Baseline, after 8 week
6 minute walking test
Baseline, after 8 week
Change from Pulmonary functions at 8 week
Time Frame: Baseline, after 8 week
Spirometry
Baseline, after 8 week
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
Baseline, after 8 week
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.
Baseline,after 8 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, after 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2019

Primary Completion (ACTUAL)

August 30, 2020

Study Completion (ACTUAL)

August 30, 2020

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (ACTUAL)

April 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MustafaKU 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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