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Completed

NCT Number: NCT05005702

Effects of Inspiratory Muscle Training on Functional Capacity in Patients With Heart Failure.

Heart failure is a complex clinical syndrome manifesting as inability to supply adequate blood flow throughout the body due to any structural or functional cardiac abnormality. The most common complaints are exercise intolerance, balance, dyspnea, and fatigue in patients with heart failure. It is clearly stated that pulmonary muscle weakness is prevalent and contributes to exercise intolerance in patients with heart failure. Purpose of the study was to evaluate the efficacy of inspiratory muscle traning on pulmonary muscle strength, pulmonary function test, functional capacity and quality of life. The tools used were 6-minute walk test, spirometry, IMT threshold device for IMT strength, and Quality of life. Study was conducted in 20 patients in single group and pre and post values were evaluated. The significance this study bears was that it helped defining for us that to how much extent we can improve the physical and pulmonary functional capacity using inspiratory muscle training. Data were analysed using spss 22.0.mean and standard deviation were calculated. Appropirate the stasitical test were used after checking normailty of data. Parametric test were used for data analysis using SPSS 22

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Hospital

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults 40-60 years old who are sedentary.
  • Left ventricular ejection fraction of less than 45% evaluated by echocardiogram
  • Functional class II and III (New York Heart Association)
  • FEV1 less than 80%, predicted and/or FEV1/ forced vital capacity (FVC) ratio of more than 70% predicted, and clinical stability.
  • Ex-smokers of more than 5 years.

Exclusion criteria

  • Myocardial infarction
  • Complex arrhythmias
  • Uncontrolled hypertension
  • Angina pectoris.
  • Cognitive disorders
  • Recent any trauma.
  • Chronic respiratory disease.
  • Unstable angina
  • Recent viral infections (6 months before the study

Treatment and study plan

Inspiratory Muscle Training

Other

Patients received IMT for 30-minute per day, 3 days per week for 3 weeks using the Threshold Inspiratory Muscle training device (product Phillips). During training, patients were instructed to maintain diaphragmatic breathing, and try to maintain 10-15 breaths, and rested 5-10 between breaths. As soon as the patients managed; they were encouraged to maintain 25-30 breaths at each workload. All patients wore nose-clip during training.

Inspiratory muscle training diaries were checked weekly. The inspiratory load was set at 40%of maximal inspiratory pressure.

Primary outcomes

  1. Six-minute walk test (6MWT) Distance

    Time frame: 6 week

    Six-minute walk test (6MWT) was applied in a 30-m unobstructed corridor. Patients and controls were instructed to walk at their own pace but to cover as much meter as possible within 6 min. Each minute standardized encouragement was given to the patients. Patients were allowed to stop and rest during the test but were instructed to go on walking as soon as they were able to do so. Heart rate and spo2 were monitored using pulse oximetry before and ending the test. Maximum heart rate values achieved during the tests were recorded. The rate of the perceived exertional scale was used before and after the 6MWT. The 6MWT distance is expressed as a percentage of the predicted values.

  2. Pulmonary function test.

    Time frame: 6 week

    Measurements of forced vital capacity and forced expiratory volume in 1, forced expiratory volume in one second/forced vital capacity, peak expiratory pressure was obtained with a computerized spiro-lab device as recommended by the European respiratory society, and results were expressed as a percentage of predicted values.

  3. SF-36

    Time frame: 6 week

    Quality of life was assessed using SF-36. The SF-36 is a generic measure, consisting of eight

    subscales and 36 items. These subscales are physical functioning, role-physical, role- emotional, mental health, social functioning, bodily pain, general health. All subscales range

    from 0 (worst possible) to100 points (best health).

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training on Functional Capacity in Patients With Heart Failure

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2021
Registry last updated
Aug 13, 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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