Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: ET+RT+ NMES

• Registration Number: NCT03577080
• Lead Sponsor: Faculty of Medicine, Sousse

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a preventable respiratory characterized by airflow obstruction that is not fully reversible. This disease a major cause of mortality worldwide. It is projected to rank the third-leading cause of death in 2020.

The objective of this study is to examine the effects of a physical therapy intervention in stable patients with COPD.

Detailed Description

Chronic obstructive pulmonary disease (COPD) patients have demonstrated important balance impairment (1).The deficit in balance control is identified as one of the risk factors of fall in subjects with COPD and alters their activities daily life (2,3). Porto and al. (2015) reported in a recent review that individuals with COPD have a decline in balance control when compared with healthy age matched controls(4).

Study Timeline

• Study Start: 2016-10-28
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-10
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

• COPD diagnosed by pulmonary function testing
• Clinically stable
• Abscence of other obstructive diseases
• Signed written consent
• Fall in the past five years or recent near fall

Exclusion Criteria

• Neuromuscular diseases
• Severe psychiatric, neurologic or musculoskeletal conditions and /or instable cardiovascular diseases.
• Contre-indications to physical therapy
• Acute exacerbations a month before the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ET+RT	ET+RT+ NMES	placebo neuromuscular electrical training NMES
ET+RT+ NMES	ET+RT+ NMES	neuromuscular electrical training NMES

Primary Outcome Measures

Name	Time	Method
Balance outcomes	baseline	The tests were performed using a stabilometric platform

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	Baseline	The BBS contains 14 items. The score obtained from 0 to 56. from 0 to 20: high risk of falling , Above 56: No risk of falling
Time Up and Go (TUG)	Baseline	The patient initially sitting on an armless chair stand up walks 3 meters and returns and sit down again. The time was recorded
Pulmonary function test	baseline	The test was performed using a Spirometry Zan 100 (Inspire Health GmbH, Germany)
Force assesment	Baselline	Maximal voluntary contraction (MVC) of the quadriceps muscle
Exercise tolerance	baseline	The 6 minutes walk test

Trial Locations

Locations (1)

Research Unit of Exercise Physiology and Pathophysiology: from integral to molecular Biology, Medicine and Health (UR12 ES06) Faculty of Medicine of Sousse; 🇹🇳 Sousse, Tunisia