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

NCT04084405 | Completed

• 1 other identifier: COPD-Balance
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; IMT; ABC; BBS; TUG; SLS

Outcome Measures

Primary Outcomes (5)

• Inspiratory muscle strengh

  The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure

  Baseline, 2 months follow up

• 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

  Baseline, 2 months follow up

• Berg Balance Scale (BBS)

  The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance.

  Baseline, 2 months follow up

• 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

  Baseline, 2 months follow up

• 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

  Baseline, 2 months follow up

Secondary Outcomes (1)

• The six minutes walk test (6MWT)

  Baseline, 2 months follow up

Study Arms (2)

IMT group

EXPERIMENTAL

Inspiratory muscle training + aerobic exercice

Other: Pulmonary rehabilitation

Control group

ACTIVE COMPARATOR

aerobic exercice

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation OTHER

The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise.

Control group; IMT group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Were COPD diagnosed by pulmonary function testing
• clinically stable
• abscence of other obstructive diseases
• signed written consert.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Study Sites (1)

Bilel TOUNSI

Sousse, 4002, Tunisia

Location

Related Publications (2)

• 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.

  PMID: 25768731 BACKGROUND

• 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.

  PMID: 34555068 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: January 1, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)