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

April 7, 2015 updated by: Dina Aboelkhair Abdallah, Mansoura University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group (group A)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure)
Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
Other Names:
  • uniphyllin, foradil, spiriva, miflonide
Other: peripheral muscles exercise training
Device: inspiratory muscle training
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
Active Comparator: control positive group (group B)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training)
Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
Other Names:
  • uniphyllin, foradil, spiriva, miflonide
Other: peripheral muscles exercise training
Active Comparator: control negative group (group C)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations
Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
Other Names:
  • uniphyllin, foradil, spiriva, miflonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in respiratory muscle strength
Time Frame: after 4 weeks and after 8 weeks of study
maximal inspiratory pressure, maximal expiratory pressure
after 4 weeks and after 8 weeks of study
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
after 4 weeks and after 8 weeks of study
changes in exercise performance
Time Frame: after 4 weeks and after 8 weeks of study
6-min walk test
after 4 weeks and after 8 weeks of study
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)
after 4 weeks and after 8 weeks of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Ahmed S Elmorsi, MD, Mansoura University
  • Study Director: Mohamad E Eldesoky, MD, Mansoura University
  • Study Director: Mona AA Mohsen, MD, Mansoura University
  • Study Director: Nesrien M Shalaby, MD, Mansoura University
  • Principal Investigator: Dina A Abdallah, MSc, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD/4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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