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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

peripheral muscles exercise training

inspiratory muscle training

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, inspiratory muscle training, dyspnea, Quality of Life

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Study group (group A)

control positive group (group B)

control negative group (group C)

Arm Description

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)

pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations

Outcomes

Primary Outcome Measures

changes in respiratory muscle strength

maximal inspiratory pressure, maximal expiratory pressure

changes in perception of dyspnea

modified Medical Research Council and modified Borg category scale

changes in exercise performance

6-min walk test

changes in quality of life

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02257463

First Posted

September 26, 2014

Last Updated

April 7, 2015

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT02257463

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, inspiratory muscle training, dyspnea, Quality of Life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group (group A)

Arm Type

Active Comparator

Arm Description

Arm Title

control positive group (group B)

Arm Type

Active Comparator

Arm Description

Arm Title

control negative group (group C)

Arm Type

Active Comparator

Arm Description

pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

uniphyllin, foradil, spiriva, miflonide

Intervention Type

Other

Intervention Name(s)

peripheral muscles exercise training

Intervention Type

Device

Intervention Name(s)

inspiratory muscle training

Other Intervention Name(s)

Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA

Intervention Description

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.

Primary Outcome Measure Information:

Title

changes in respiratory muscle strength

Description

maximal inspiratory pressure, maximal expiratory pressure

Time Frame

after 4 weeks and after 8 weeks of study

Title

changes in perception of dyspnea

Description

modified Medical Research Council and modified Borg category scale

Time Frame

after 4 weeks and after 8 weeks of study

Title

changes in exercise performance

Description

6-min walk test

Time Frame

after 4 weeks and after 8 weeks of study

Title

changes in quality of life

Description

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

Time Frame

after 4 weeks and after 8 weeks of study

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: