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Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03923153
Enrollment
40
Registered
2019-04-22
Start date
2019-04-15
Completion date
2020-08-30
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina, Stable

Keywords

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

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.

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.

Interventions

DEVICEInspiratory 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.

DEVICESham 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.

Sponsors

Mustafa Kemal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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%)

Design outcomes

Primary

MeasureTime frameDescription
Change of the Inspiratory and expiratory muscle strength (MIP, MEP) from baseline to 8 weekBaseline, after 8 weekMouth pressure device( MicroRPM, Micro Medical England)

Secondary

MeasureTime frameDescription
Change from Baseline Functional exercise capacity at 8 weekBaseline, after 8 week6 minute walking test
Change from Pulmonary functions at 8 weekBaseline, after 8 weekSpirometry
FatigueBaseline, after 8 weekChange 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
DepressionBaseline,after 8 weekChange 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

MeasureTime frameDescription
Quality lifeBaseline, after 8 weekChange 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026