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Effect of Inspiratory Muscle Training During Pulmonary Rehabilitation on Balance in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
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, ABC, BBS, TUG, SLS

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 group

Control group

Arm Description

Inspiratory muscle training + aerobic exercice

aerobic exercice

Outcomes

Primary Outcome Measures

Inspiratory muscle strengh
The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure
ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC)
The ABC scale requires patients to indicate their confidence in performing 16 activities without losing their balance or becoming unsteady on an 11-point scale (0%-100%).Higher scores indicates higher balance confidence and lower scores indicates poor balance confidence
Berg Balance Scale (BBS)
The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance.
Single Leg Stance (SLS)
Patients selected the leg on which they they preferred to stand for the test. They were instructed to keep their legs from touching and to maintain a unipedal stance for as long as possible
Timed Up and Go (TUG)
The test requires the patient to rise from a standard armchair, walk 3 m at a comfortable pace, walk back to the chair, and sit down

Secondary Outcome Measures

The six minutes walk test (6MWT)
The test provides estimate endurance and funcional performance of patients

Full Information

First Posted
September 5, 2019
Last Updated
January 31, 2020
Sponsor
Faculty of Medicine, Sousse
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1. Study Identification

Unique Protocol Identification Number
NCT04084405
Brief Title
Effect of Inspiratory Muscle Training During Pulmonary Rehabilitation on Balance in COPD Patients
Official Title
Effect of Inspiratory Muscle Training on Balance During PR in Chronic Obstructive Pulmonary Disease Patients (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 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 (COPD) is a respiratory disease that results in progressive airflow limitation and respiratory distress. Physiopathological features of COPD suggest that people who suffer from this disease have many risk factors for falls that have been identified in older individuals. The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme (PRP) is uncertain. The investigators aimed to demonstrate that,in chronic obstructive pulmonary disease (COPD) patients, IMT performed during a PRP is associated with an improvement of Balance.
Detailed Description
Chronic obstructive pulmonary disease COPD is a preventable and treatable disease(GOLD, 2017). According to the WHO, COPD would be the third leading cause of death by 2030 (WHO, 2017). This disease is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases(GOLD, 2017). However, emerging data showed that COPD patients demonstrate important deficits in balance and control which associated to a high risk of fall ( Butcher et al, 2004 ; Smith et al, 2009 ; Beauchamp et al, 2009 ; Beauchamp et al, 2010). Inspiratory muscle training (IMT) has been shown to be an effective modality for COPD patients for improving the maximal inspiratory muscle strength, the dyspnea and health-related quality of life (GI COPD, 2016). However, the effect of inspiratory muscle training on balance is not studying. The purpose of this study is to evaluate the effect of the inspiratory muscles training on balance 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, ABC, BBS, TUG, SLS

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
IMT group
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
Intervention Description
The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise.
Primary Outcome Measure Information:
Title
Inspiratory muscle strengh
Description
The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure
Time Frame
Baseline, 2 months follow up
Title
ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC)
Description
The ABC scale requires patients to indicate their confidence in performing 16 activities without losing their balance or becoming unsteady on an 11-point scale (0%-100%).Higher scores indicates higher balance confidence and lower scores indicates poor balance confidence
Time Frame
Baseline, 2 months follow up
Title
Berg Balance Scale (BBS)
Description
The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance.
Time Frame
Baseline, 2 months follow up
Title
Single Leg Stance (SLS)
Description
Patients selected the leg on which they they preferred to stand for the test. They were instructed to keep their legs from touching and to maintain a unipedal stance for as long as possible
Time Frame
Baseline, 2 months follow up
Title
Timed Up and Go (TUG)
Description
The test requires the patient to rise from a standard armchair, walk 3 m at a comfortable pace, walk back to the chair, and sit down
Time Frame
Baseline, 2 months follow up
Secondary Outcome Measure Information:
Title
The six minutes walk test (6MWT)
Description
The test provides estimate endurance and funcional performance of patients
Time Frame
Baseline, 2 months follow up

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
25768731
Citation
Crisan AF, Oancea C, Timar B, Fira-Mladinescu O, Tudorache V. Balance impairment in patients with COPD. PLoS One. 2015 Mar 13;10(3):e0120573. doi: 10.1371/journal.pone.0120573. eCollection 2015.
Results Reference
background
PubMed Identifier
34555068
Citation
Tounsi B, Acheche A, Lelard T, Tabka Z, Trabelsi Y, Ahmaidi S. Effects of specific inspiratory muscle training combined with whole-body endurance training program on balance in COPD patients: Randomized controlled trial. PLoS One. 2021 Sep 23;16(9):e0257595. doi: 10.1371/journal.pone.0257595. eCollection 2021.
Results Reference
derived

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Effect of Inspiratory Muscle Training During Pulmonary Rehabilitation on Balance in COPD Patients

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