Chronic Obstructive Pulmonary Disease (COPD)

September 5, 2019 updated by: Acheche Amal, Faculty of Medicine, Sousse

The Effect of Adding Neuromuscular Electrical Stimulation to Endurance and Resistance Training on Exercise Capacity and Balance in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ET+RT+ NMES
neuromuscular electrical training NMES
Endurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased.
Placebo Comparator: ET+RT
placebo neuromuscular electrical training NMES
Endurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance outcomes
Time Frame: baseline
The tests were performed using a stabilometric platform
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function test
Time Frame: baseline
The test was performed using a Spirometry Zan 100 (Inspire Health GmbH, Germany)
baseline
Exercise tolerance
Time Frame: baseline
The 6 minutes walk test
baseline
Force assesment
Time Frame: Baselline
Maximal voluntary contraction (MVC) of the quadriceps muscle
Baselline
Time Up and Go (TUG)
Time Frame: Baseline
The patient initially sitting on an armless chair stand up walks 3 meters and returns and sit down again. The time was recorded
Baseline
Berg Balance Scale (BBS)
Time Frame: 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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amal Acheche, phd, Faculty of medecine Sousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 10, 2017

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 9, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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