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Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
ET+RT+ NMES
Sponsored by
Faculty of Medicine, Sousse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Exercise training

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ET+RT+ NMES

ET+RT

Arm Description

neuromuscular electrical training NMES

placebo neuromuscular electrical training NMES

Outcomes

Primary Outcome Measures

Balance outcomes
The tests were performed using a stabilometric platform

Secondary Outcome Measures

Pulmonary function test
The test was performed using a Spirometry Zan 100 (Inspire Health GmbH, Germany)
Exercise tolerance
The 6 minutes walk test
Force assesment
Maximal voluntary contraction (MVC) of the quadriceps muscle
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
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

Full Information

First Posted
June 5, 2018
Last Updated
September 5, 2019
Sponsor
Faculty of Medicine, Sousse
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1. Study Identification

Unique Protocol Identification Number
NCT03577080
Brief Title
Chronic Obstructive Pulmonary Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 28, 2016 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Medicine, Sousse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, Exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Differents groups received differents training protocoles during the same duration
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ET+RT+ NMES
Arm Type
Active Comparator
Arm Description
neuromuscular electrical training NMES
Arm Title
ET+RT
Arm Type
Placebo Comparator
Arm Description
placebo neuromuscular electrical training NMES
Intervention Type
Other
Intervention Name(s)
ET+RT+ NMES
Intervention Description
Endurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased.
Primary Outcome Measure Information:
Title
Balance outcomes
Description
The tests were performed using a stabilometric platform
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Pulmonary function test
Description
The test was performed using a Spirometry Zan 100 (Inspire Health GmbH, Germany)
Time Frame
baseline
Title
Exercise tolerance
Description
The 6 minutes walk test
Time Frame
baseline
Title
Force assesment
Description
Maximal voluntary contraction (MVC) of the quadriceps muscle
Time Frame
Baselline
Title
Time Up and Go (TUG)
Description
The patient initially sitting on an armless chair stand up walks 3 meters and returns and sit down again. The time was recorded
Time Frame
Baseline
Title
Berg Balance Scale (BBS)
Description
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
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Acheche, phd
Organizational Affiliation
Faculty of medecine Sousse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Unit of Exercise Physiology and Pathophysiology: from integral to molecular Biology, Medicine and Health (UR12 ES06) Faculty of Medicine of Sousse
City
Sousse
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20206529
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.
Results Reference
result
PubMed Identifier
19592229
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.
Results Reference
result
PubMed Identifier
20869227
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.
Results Reference
result
PubMed Identifier
26170652
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.
Results Reference
result

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Chronic Obstructive Pulmonary Disease

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