COPDCOPDNCT03577080
Chronic Obstructive Pulmonary Disease
A study testing ET+RT+ NMES in people with COPD, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- COPD
- What is being tested?
- ET+RT+ NMES
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTunisia
- Study dates
- 28 Oct 2016to 10 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Research Unit of Exercise Physiology and Pathophysiology: from integral to molecular Biology, Medicine and Health (UR12 ES06) Faculty of Medicine of Sousse
Sousse
About this study
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
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.
Read the 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).
- Conditions
- COPD
- Being tested
- ET+RT+ NMES
- Keywords
- COPD, Exercise training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET+RT+ NMESOther
Endurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased.
| Study group | Role | What they receive |
|---|---|---|
| ET+RT+ NMES | Active comparator | neuromuscular electrical training NMES Receives: Other: ET+RT+ NMES |
| ET+RT | Placebo comparator | placebo neuromuscular electrical training NMES Receives: Other: ET+RT+ NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance outcomes
The tests were performed using a stabilometric platform
Measured: baseline
Secondary outcomes (5)
Pulmonary function test
The test was performed using a Spirometry Zan 100 (Inspire Health GmbH, Germany)
Measured: baseline
Exercise tolerance
The 6 minutes walk test
Measured: baseline
Force assesment
Maximal voluntary contraction (MVC) of the quadriceps muscle
Measured: Baselline
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
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start28 Oct 2016
- Primary completion1 Jun 2017
- Study completion10 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Differents groups received differents training protocoles during the same duration
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Acheche Amal, Faculty of Medicine, Sousse
- Investigators
- Amal Acheche, phd, Principal investigator, Faculty of medecine Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577080
- Sponsor's protocol ID
- COPD
- Acronym
- COPD
- Status last verified
- Sep 2019
- First submitted
- 5 Jun 2018
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20206529Beauchamp 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.
PubMed 19592229Roig 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.
PubMed 20869227Porto 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.
PubMed 26170652
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03577080
- Acronym / sponsor ID
- COPD / COPD
- Conditions
- COPD
- Keywords
- COPD, Exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 28 Oct 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 10 Jun 2017 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Differents groups received differents training protocoles during the same duration
| Arm | Type | Receives |
|---|---|---|
| ET+RT+ NMES | Active comparator | Other: ET+RT+ NMESneuromuscular electrical training NMES |
| ET+RT | Placebo comparator | Other: ET+RT+ NMESplacebo neuromuscular electrical training NMES |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ET+RT+ NMESEndurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased. | Other | ET+RT, ET+RT+ NMES |
Primary outcome
Balance outcomes
Time frame: baseline
The tests were performed using a stabilometric platform
5 secondary outcomes
Pulmonary function test
Time frame: baseline
Exercise tolerance
Time frame: baseline
Force assesment
Time frame: Baselline
Time Up and Go (TUG)
Time frame: Baseline
Berg Balance Scale (BBS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Results publication: PubMed 20206529Smith 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 publication: PubMed 19592229Beauchamp 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 publication: PubMed 20869227Roig 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 publication: PubMed 26170652Porto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Acheche, phd principal investigator
Faculty of medecine Sousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ET+RT+ NMES in people with COPD, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance outcomes (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577080, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.