Clinical trial NCT03577080: Chronic Obstructive Pulmonary Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD, Exercise training
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 42
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Differents groups received differents training protocoles during the same duration
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Balance outcomes
timeFrame: baseline
Secondary outcomes:
measure: Pulmonary function test
timeFrame: baseline
measure: Exercise tolerance
timeFrame: baseline
measure: Force assesment
timeFrame: Baselline
measure: Time Up and Go (TUG)
timeFrame: Baseline
measure: Berg Balance Scale (BBS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Research Unit of Exercise Physiology and Pathophysiology: from integral to molecular Biology, Medicine and Health (UR12 ES06) Faculty of Medicine of Sousse
Study officials:
affiliation: Faculty of medecine Sousse
name: Amal Acheche, phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: Porto EF, Castro AA, Schmidt VG, Rabelo HM, Kumpel 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 2015.