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

NCT02257463 | Completed DMC

• 1 other identifier: MD/4
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; inspiratory muscle training; dyspnea; Quality of Life

Outcome Measures

Primary Outcomes (4)

• changes in respiratory muscle strength

  maximal inspiratory pressure, maximal expiratory pressure

  after 4 weeks and after 8 weeks of study

• changes in perception of dyspnea

  modified Medical Research Council and modified Borg category scale

  after 4 weeks and after 8 weeks of study

• changes in exercise performance

  6-min walk test

  after 4 weeks and after 8 weeks of study

• changes in quality of life

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

  after 4 weeks and after 8 weeks of study

Study Arms (3)

Study group (group A)

ACTIVE COMPARATOR

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: peripheral muscles exercise training; Device: inspiratory muscle training

control positive group (group B)

ACTIVE COMPARATOR

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: peripheral muscles exercise training

control negative group (group C)

ACTIVE COMPARATOR

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

Interventions

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

Also known as: uniphyllin, foradil, spiriva, miflonide

Study group (group A); control negative group (group C); control positive group (group B)

peripheral muscles exercise training OTHER

Study group (group A); control positive group (group B)

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.

Also known as: Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA

Study group (group A)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Theophylline; Formoterol Fumarate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Ahmed S Elmorsi, MD

  Mansoura University

  STUDY CHAIR

• Mohamad E Eldesoky, MD

  Mansoura University

  STUDY DIRECTOR

• Mona AA Mohsen, MD

  Mansoura University

  STUDY DIRECTOR

• Nesrien M Shalaby, MD

  Mansoura University

  STUDY DIRECTOR

• Dina A Abdallah, MSc

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer in chest medicine

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 6, 2014
• Study Start: October 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2014-10