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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

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 September 9, 2020

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:Angina, Stable
  • Intervention/Treatment: Device: Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
    Device: Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)
    Device: High intensityInspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
  • Phase: N/A
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
  • Actual Enrollment: 60 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 2019
  • Actual Primary Completion Date: August 2020
  • Actual Study Completion Date: August 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.
Active Comparator: High intensity Inspiratory muscle training group
High intensity Inspiratory muscle training group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device
Device: High intensityInspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)
Treatment group III will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 50% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 50% 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 Pulmonary functions at 8 week [ Time Frame: Baseline, after 8 week ]
    Spirometry
  • 2. Change from Baseline Functional exercise capacity at 8 week [ Time Frame: Baseline, after 8 week ]
    6 minute walking test
  • 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
Contacts
Locations

Turkey, Merkez
Hatay Mustafa Kemal University
Hatay

Sponsors and Collaborators

Mustafa Kemal University

Investigators

Study Director: Aysel yıldız, assoc prof Marmara University Faculty of Health Sciences

Study Chair: Irem Hüzmeli, Msc hatay 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