NCT03577080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

June 5, 2018

Last Update Submit

September 5, 2019

Conditions

COPD

Keywords

COPD, Exercise training

Outcome Measures

Primary Outcomes (1)

  • Balance outcomes

    The tests were performed using a stabilometric platform

    baseline

Secondary Outcomes (5)

  • Pulmonary function test

    baseline

  • Exercise tolerance

    baseline

  • Force assesment

    Baselline

  • Time Up and Go (TUG)

    Baseline

  • Berg Balance Scale (BBS)

    Baseline

Study Arms (2)

ET+RT+ NMES

ACTIVE COMPARATOR

neuromuscular electrical training NMES

Other: ET+RT+ NMES

ET+RT

PLACEBO COMPARATOR

placebo neuromuscular electrical training NMES

Other: ET+RT+ NMES

Interventions

ET+RT+ NMESOTHER

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

ET+RTET+RT+ NMES

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Sousse, Tunisia

Location

Related Publications (4)

  • 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.

    PMID: 20206529RESULT

  • 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.

    PMID: 19592229RESULT

  • 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.

    PMID: 20869227RESULT

  • 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.

    PMID: 26170652RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amal Acheche, phd

    Faculty of medecine Sousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Differents groups received differents training protocoles during the same duration
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 5, 2018

First Posted

July 5, 2018

Study Start

October 28, 2016

Primary Completion

June 1, 2017

Study Completion

June 10, 2017

Last Updated

September 9, 2019

Record last verified: 2019-09

Locations

TU(1)