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OpenTrials
Completed

NCT Number: NCT02257463

Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Exsmokers
  • Low PImax compared to reference values [lower limits of normal: 80 cmH2O for patients less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and 65 cmH2O for patients 65 years old ].
  • Stable patients without history of exacerbation or hospitalization four weeks before starting the study.

Exclusion criteria

  • Lack of motivation and compliance.
  • Patients with significant reversibility following bronchodilation defined as an increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value
  • Unstable cardiac disease [severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)].
  • Uncontrolled hypertension
  • Recent pneumothorax (within 6 weeks)
  • Recent abdominal or thoracic surgery (within 6 weeks)
  • Known progressive neuromuscular disorders
  • Recent gastrointestinal bleeding (within 4 weeks)
  • Current smokers
  • Active cancer
  • Patients with advanced liver diseases, or renal impairment.
  • Known connective tissue diseases
  • Significant endocrinal abnormalities

Treatment and study plan

theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations

Drug

Other names: uniphyllin, foradil, spiriva, miflonide

peripheral muscles exercise training

Other

Inspiratory muscle training

Device

Patients started breathing at a resistance that required generation of 30% of their PImax for one week. The load was then increased incrementally, 5-10%, to reach generation of 60% of their PImax at the end of the first month. Specific IMT was then continued at 60% of their PImax adjusted weekly to the new PImax achieved.

Other names: Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA

Primary outcomes

  1. changes in respiratory muscle strength

    Time frame: after 4 weeks and after 8 weeks of study

    maximal inspiratory pressure, maximal expiratory pressure

  2. changes in perception of dyspnea

    Time frame: after 4 weeks and after 8 weeks of study

    modified Medical Research Council and modified Borg category scale

  3. changes in exercise performance

    Time frame: after 4 weeks and after 8 weeks of study

    6-min walk test

  4. changes in quality of life

    Time frame: after 4 weeks and after 8 weeks of study

    BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 6, 2014
Registry last updated
Apr 8, 2015

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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