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NCT Number: NCT03923153

Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

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.

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Key information

Conditions

Angina, Stable Angina Pectoris Behavior Behavioral Symptoms Cardiovascular Diseases Chest Pain Depression Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hatay Mustafa Kemal University

Hatay, Merkez, 31010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)

Device

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)

Device

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2019
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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