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Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Pulmonary rehabilitation+IMT
Pulmonary rehabilitation
Sponsored by
Faculty of Medicine, Sousse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, IMT, 6MWT, Dyspoea, SGRQ

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Were COPD diagnosed by pulmonary function testing
  • Clinically stable
  • Abscence of other obstructive diseases
  • Signed written consert

Exclusion Criteria:

  • Were previous pneumonectomy or lobectomy in the past 6 months
  • spontaneous risk of pneumothorax or rib fracture
  • Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
  • The absence of written informed consent.

Sites / Locations

  • Bilel TOUNSI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMT goup

Control group

Arm Description

Inspiratory muscle training + aerobic exercice

aerobic exercice

Outcomes

Primary Outcome Measures

Dyspnoea
The dyspnoea were measured before and after the 6 minutes walk test
Inspiratory muscle strength
The inspiratory muscle strength were measured by maximal inspiratory pressure test

Secondary Outcome Measures

Full Information

First Posted
September 30, 2019
Last Updated
January 31, 2020
Sponsor
Faculty of Medicine, Sousse
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1. Study Identification

Unique Protocol Identification Number
NCT04120142
Brief Title
Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in COPD Patients
Official Title
Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in Chronic Obstructive (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Medicine, Sousse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Chronic obstructive pulmonary disease is a respiratory disease that results in progressive airflow limitation and respiratory distress. The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme is uncertain. The investigators aimed to demonstrate that, in patients with obstructive pulmonary disease, IMT performed during a PRP is associated with an improvement of dyspnoea and exercise tolerance.
Detailed Description
The purpose of this study is to evaluate the effect of the inspiratory muscle training (with incremental load every two weeks in two months) performed during pulmonary rehabilitation on dyspnoea, 6 minutes walk test and quality of life using the St George's respiratory questionnaire (SGRQ) in COPD patients.

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, IMT, 6MWT, Dyspoea, SGRQ

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT goup
Arm Type
Experimental
Arm Description
Inspiratory muscle training + aerobic exercice
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
aerobic exercice
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation+IMT
Intervention Description
The experimental group receives inspiratory muscle training and aerobic exercise.
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
The Active Comparator group received only aerobic exercise.
Primary Outcome Measure Information:
Title
Dyspnoea
Description
The dyspnoea were measured before and after the 6 minutes walk test
Time Frame
Baseline, After 2 months
Title
Inspiratory muscle strength
Description
The inspiratory muscle strength were measured by maximal inspiratory pressure test
Time Frame
Baseline, After 2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Were COPD diagnosed by pulmonary function testing Clinically stable Abscence of other obstructive diseases Signed written consert Exclusion Criteria: Were previous pneumonectomy or lobectomy in the past 6 months spontaneous risk of pneumothorax or rib fracture Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme) The absence of written informed consent.
Facility Information:
Facility Name
Bilel TOUNSI
City
Sousse
ZIP/Postal Code
4002
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25858974
Citation
Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.
Results Reference
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PubMed Identifier
29371379
Citation
Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.
Results Reference
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PubMed Identifier
29371389
Citation
Ambrosino N. Inspiratory muscle training in stable COPD patients: enough is enough? Eur Respir J. 2018 Jan 25;51(1):1702285. doi: 10.1183/13993003.02285-2017. Print 2018 Jan. No abstract available.
Results Reference
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Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in COPD Patients

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