Chronic Obstructive Pulmonary Disease

NCT ID: NCT03577080

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-28

Study Completion Date

2017-06-10

Brief Summary

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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

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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).

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Differents groups received differents training protocoles during the same duration
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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ET+RT+ NMES

neuromuscular electrical training NMES

Group Type ACTIVE_COMPARATOR

ET+RT+ NMES

Intervention Type OTHER

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

ET+RT

placebo neuromuscular electrical training NMES

Group Type PLACEBO_COMPARATOR

ET+RT+ NMES

Intervention Type OTHER

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

Interventions

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ET+RT+ NMES

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Faculty of Medicine, Sousse

OTHER

Sponsor Role lead

Responsible Party

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Acheche Amal

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amal Acheche, phd

Role: PRINCIPAL_INVESTIGATOR

Faculty of medecine Sousse

Locations

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

Sousse, , Tunisia

Site Status

Countries

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Tunisia

References

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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.

Reference Type RESULT
PMID: 20206529 (View on PubMed)

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.

Reference Type RESULT
PMID: 19592229 (View on PubMed)

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.

Reference Type RESULT
PMID: 20869227 (View on PubMed)

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.

Reference Type RESULT
PMID: 26170652 (View on PubMed)

Other Identifiers

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COPD

Identifier Type: -

Identifier Source: org_study_id

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