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OpenTrials
Completed

NCT Number: NCT03577080

Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

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

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Sousse, Tunisia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ET+RT+ NMES

Other

Endurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased.

Primary outcomes

  1. Balance outcomes

    Time frame: baseline

    The tests were performed using a stabilometric platform

Secondary outcomes

  1. Pulmonary function test

    Time frame: baseline

    The test was performed using a Spirometry Zan 100 (Inspire Health GmbH, Germany)

  2. Exercise tolerance

    Time frame: baseline

    The 6 minutes walk test

  3. Force assesment

    Time frame: Baselline

    Maximal voluntary contraction (MVC) of the quadriceps muscle

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Faculty of Medicine, Sousse

Other

Registry information

Official study title

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

Acronym: COPD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 5, 2018
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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