Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

— COPD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577080
• Other study ID #: COPD
• Status: Completed
• Phase: N/A
• Start date: October 28, 2016
• Est. completion date: June 10, 2017

Study information

• Verified date: September 2019
• Source: Faculty of Medicine, Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 10, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• ET+RT+ NMES
Endurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, Sousse

Country where clinical trial is conducted

Tunisia, 

References & Publications (4)

Beauchamp MK, Hill K, Goldstein RS, Janaudis-Ferreira T, Brooks D. Impairments in balance discriminate fallers from non-fallers in COPD. Respir Med. 2009 Dec;103(12):1885-91. doi: 10.1016/j.rmed.2009.06.008. Epub 2009 Jul 9. — View Citation

Porto EF, Castro AA, Schmidt VG, Rabelo HM, Kümpel C, Nascimento OA, Jardim JR. Postural control in chronic obstructive pulmonary disease: a systematic review. Int J Chron Obstruct Pulmon Dis. 2015 Jun 29;10:1233-9. doi: 10.2147/COPD.S63955. eCollection 2 — View Citation

Roig M, Eng JJ, MacIntyre DL, Road JD, FitzGerald JM, Burns J, Reid WD. Falls in people with chronic obstructive pulmonary disease: an observational cohort study. Respir Med. 2011 Mar;105(3):461-9. doi: 10.1016/j.rmed.2010.08.015. — View Citation

Smith MD, Chang AT, Seale HE, Walsh JR, Hodges PW. Balance is impaired in people with chronic obstructive pulmonary disease. Gait Posture. 2010 Apr;31(4):456-60. doi: 10.1016/j.gaitpost.2010.01.022. Epub 2010 Mar 4. — View Citation

Outcome

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