Chronic Obstructive Pulmonary DiseaseNCT04387318

Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease

A study testing Multimodal training, IMT + Pulmonary Rehabilitation and NMES + Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Santa Maria at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Multimodal training, IMT + Pulmonary Rehabilitation and NMES + Pulmonary Rehabilitation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteBrazil
Study dates: 1 Oct 2019to 10 Mar 2023
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 55 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of COPD, in stages II, III and IV, according to criteria of the Global Initiative for COPD (GOLD);
Clinically stable, i.e., absence of infections or exacerbations in the last 3 months;
Medical team allows patient to exercise
Availability of attending the rehabilitation program.

Who cannot join

Unstable primary pathologies (cardiovascular, renal, metabolic, psychiatric);
Hemodynamic instability;
Nutritional supplementation on the 4 weeks preceding the study;
Severe hearing or visual impairment recorded on patient chart or self-referred;
Obesity (BMI > 30 kg/m2);
Neurological or musculoskeletal condition that severely limits mobility and postural control, thus making it impossible to carry out the assessments;

Show all 15Show fewer

Electronic devices, such as heart pacemakers and implantable cardioverter defibrillator;
Skin injuries and infection where electrodes would be placed;
Prior participation in pulmonary rehabilitation programs 3 months previous to the study;
Vertigo;
Active smoker and/or alcoholic;
Neurological impairment or cerebellar lesions;
Deficit in cognitive function;
Severe vitamin D deficiency;
Physically active.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal de Santa Maria
Santa Maria, Rio Grande do Sul, 97105900

Other trials in Brazil

About this study

Official title: Effects of Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a significant current public health problem, characterized by the presence of limited airflow. However, COPD has important manifestations beyond the lungs, the so-called systemic effects. These included dysfunction of peripheral and respiratory muscles. The growing amount of evidence has shown that patients with COPD also present important deficits in postural balance and consequently, increased risk of falling. As an essential part of the management of COPD, pulmonary rehabilitation (PR) alleviates dyspnea and fatigue, improves exercise tolerance and health-related quality of life, and reduces hospital admissions and mortality for COPD patients. Exercise is the key component of PR, which is composed of exercise assessment and training therapy. Currently, two modalities of therapy have been suggested as complementary to pulmonary rehabilitation: inspiratory muscular training (IMT) and neuromuscular electrical stimulation (NMES). Based on the premise that peripheral and respiratory muscle dysfunction can negatively impact postural control of patients with COPD, and given the importance of balance as a modifiable risk factor for falls, it is important to investigate whether the use of these therapeutic modalities (IMT and/or NMES) is capable of improving the short-term effects of pulmonary rehabilitation and also promoting improved balance.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Multimodal training, IMT + Pulmonary Rehabilitation, NMES + Pulmonary Rehabilitation, Pulmonary Rehabilitation
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.

Multimodal trainingDevice
IMT will be performed using the POWERbreathe® Medic Plus inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. The IMT wil be performed two times per week for 8 weeks.
NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks.
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
IMT + Pulmonary RehabilitationDevice
IMT will be performed using the POWERbreathe® Medic Plus (POWERbreathe Medic Plus ®, SP, BR) inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. After that, load increases occurred as follows: 35% of MIP in week 3, 40% of MIP in week 4, 45% of MIP in week 5, 50% of MIP at week 6, 55% of MIP in week 7, and 60% of MIP in weeks 8.
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
NMES + Pulmonary RehabilitationDevice
NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks.
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
Pulmonary RehabilitationDevice
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.

Study groups in NCT04387318
Study group	Role	What they receive
Multimodal training	Experimental	IMT + NMES + Pulmonary Rehabilitation IMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise. Receives: Device: Multimodal training
IMT + Pulmonary Rehabilitation	Experimental	IMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise. Receives: Device: IMT + Pulmonary Rehabilitation
NMES + Pulmonary Rehabilitation	Experimental	NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise. Receives: Device: NMES + Pulmonary Rehabilitation
Pulmonary Rehabilitation	Placebo comparator	Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise. Receives: Device: Pulmonary Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Static postural balance
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of pressure displacement amplitude in the anteroposterior direction (COP) (cm).
Measured: Post-intervention (change after 8 weeks of training)
Static postural balance
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the area of ellipse (AE) (cm2).
Measured: Post-intervention (change after 8 weeks of training)
Static postural balance
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the velocity of displacement of center of pressure (COPvel) (cm/s).
Measured: Post-intervention (change after 8 weeks of training)
Static postural balance
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of area of pressure and area of ellipse (AE) (cm2).
Measured: Post-intervention (change after 8 weeks of training)

Secondary outcomes (23)

Static postural balance
Static postural balance (%) will assessed through Foam-Laser dynamic posturography.
Measured: Post-intervention (change after 8 weeks of training)
Static and dynamic postural balance
Static and dynamic postural balance will assessed using the Berg Balance Scale (score points). Scores range from 0 to 56, with higher scores indicating better balance.
Measured: Post-intervention (change after 8 weeks of training)
Static and dynamic postural balance
Static and dynamic postural balance will assessed using the Balance Evaluation Systems Test (score points). The total score of the test (108 points) will be calculated with a percentage score (0-100%) and higher scores indicate better balance performance.
Measured: Post-intervention (change after 8 weeks of training)
Dynamic postural balance
Dynamic postural balance will assessed using the Timed Up and Go (seconds). A faster time indicate a better functional performance and a score of ≥12 seconds used as a cut-point.
Measured: Post-intervention (change after 8 weeks of training)
Balance confidence questionnaire
Balance confidence questionnaire will measured through the Activities Specific Balance Confidence Scale (total score points). The questionnaire contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).
Measured: Post-intervention (change after 8 weeks of training)
Balance confidence questionnaire
Balance confidence questionnaire will measured through Falls Efficacy Scale-International (total score points). The total score ranges from 16 to 64 points. Higher values indicate less fall-related self-efficacy (and more concern about falling).
Measured: Post-intervention (change after 8 weeks of training)
Peripheral muscle strength
Handgrip strength and quadriceps muscle strength will be assessed by dynamometry, respectively, Kgf and Newtons.
Measured: Post-intervention (change after 8 weeks of training)
Respiratory muscle strength and inspiratory muscle endurance
Respiratory muscle strength (cmH2O) and inspiratory muscle endurance (cmH2O) will measured through digital pressure manometry and incremental and constant test, respectively
Measured: Post-intervention (change after 8 weeks of training)
Quadriceps femoris and diaphragm thickness
Quadriceps femoris and diaphragm thickness will measured by ultrasonography
Measured: Post-intervention (change after 8 weeks of training)
Submaximal level of functional capacity
Submaximal level of functional capacity will measured by 6-minute walk test
Measured: Post-intervention (change after 8 weeks of training)
Health-related quality of life at 8 week
Health-related quality of life will measured by Saint George's Respiratory Questionnaire. Overall scores range from 0 (no effect on quality of life) to a maximum score of 100 (maximum perceived distress).
Measured: Post-intervention (change after 8 weeks of training)
Oxidant profile
The oxidant profile will be assessed by Dichlorofluorescein Diacetate - DCF-DA (picomoles / mL).
Measured: Post-intervention (change after 8 weeks of training)
Oxidant profile
The oxidant profile will be assessed by Thiobarbituric Acid Reactive Substances -TBARS (nmol de MDA/mL).
Measured: Post-intervention (change after 8 weeks of training)
Oxidant profile
The oxidant profile will be assessed by Advanced Oxidation Protein Products - AOPPs (µmol/L).
Measured: Post-intervention (change after 8 weeks of training)
Oxidant profile
The oxidant profile will be assessed by Total Oxidant Status - TOS (mmol Trolox Equiv/L).
Measured: Post-intervention (change after 8 weeks of training)
Antioxidant profile
The antioxidant profile will be assessed by Ferric Reducing Antioxidant Power - FRAP- (µmol/L)
Measured: Post-intervention (change after 8 weeks of training)
Antioxidant profile
The antioxidant profile will be assessed by Total Antioxidant Capacity- CAT (mmol Trolox Equiv/L).
Measured: Post-intervention (change after 8 weeks of training)
Muscle damage
Muscle damage will assessed through creatine phosphokinase (total CPK) (U/L).
Measured: Post-intervention (change after 8 weeks of training)
Muscle damage
Muscle damage will assessed through lactate dehydrogenase (LDH) (U/L).
Measured: Post-intervention (change after 8 weeks of training)
Muscle damage
Muscle damage will assessed through lactate parameter (mg/dL).
Measured: Post-intervention (change after 8 weeks of training)
DNA damage
DNA damage will assessed by means of the Comet and micronucleus assay
Measured: Post-intervention (change after 8 weeks of training)
Endothelial function
Endothelial function will assessed through nitrite/nitrate oxide (NOx) (µmol/L)
Measured: Post-intervention (change after 8 weeks of training)
Peripheral muscle resistance of the lower limbs
Peripheral muscle resistance of the lower limbs will assessed through 30-second Sit-to-Stand tests (repetitions)
Measured: Post-intervention (change after 8 weeks of training)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201910 Mar 2023

First posted13 May 2020
Study start1 Oct 2019
Primary completion10 Mar 2023
Study completion10 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04387318
Sponsor's protocol ID: 08527219.0.0000.5346
Status last verified: May 2023
First submitted: 1 May 2020
Last updated: 31 May 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Daros Dos Santos T, Pasqualoto AS, Cardoso DM, Da Cruz IBM, Moresco RN, Ferreira da Silveira A, Martins de Albuquerque I. Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2023 Aug 15;24(1):532. doi: 10.1186/s13063-023-07558-9.
PubMed 37580800

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Patients With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT04387318
Acronym / sponsor ID: 08527219.0.0000.5346
Conditions: Chronic Obstructive Pulmonary Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Universidade Federal de Santa MariaUniversity, hospital or other
Study start: 1 Oct 2019 (actual)
Primary completion: 10 Mar 2023 (actual)
Study completion: 10 Mar 2023 (actual)
First posted: 13 May 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Multimodal training	Experimental	Device: Multimodal trainingIMT + NMES + Pulmonary Rehabilitation IMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.
IMT + Pulmonary Rehabilitation	Experimental	Device: IMT + Pulmonary RehabilitationIMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.
NMES + Pulmonary Rehabilitation	Experimental	Device: NMES + Pulmonary RehabilitationNMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.
Pulmonary Rehabilitation	Placebo comparator	Device: Pulmonary RehabilitationPulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.

Who may qualify

Ages: 55 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Clinical diagnosis of COPD, in stages II, III and IV, according to criteria of the Global Initiative for COPD (GOLD);
Clinically stable, i.e., absence of infections or exacerbations in the last 3 months;
Medical team allows patient to exercise
Availability of attending the rehabilitation program.

Key exclusion criteria (15 listed)

Unstable primary pathologies (cardiovascular, renal, metabolic, psychiatric);
Hemodynamic instability;
Nutritional supplementation on the 4 weeks preceding the study;
Severe hearing or visual impairment recorded on patient chart or self-referred;
Obesity (BMI > 30 kg/m2);

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
Multimodal trainingIMT will be performed using the POWERbreathe® Medic Plus inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. The IMT wil be performed two times per week for 8 weeks. NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks. Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.	Device	Multimodal training
IMT + Pulmonary RehabilitationIMT will be performed using the POWERbreathe® Medic Plus (POWERbreathe Medic Plus ®, SP, BR) inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. After that, load increases occurred as follows: 35% of MIP in week 3, 40% of MIP in week 4, 45% of MIP in week 5, 50% of MIP at week 6, 55% of MIP in week 7, and 60% of MIP in weeks 8. Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.	Device	IMT + Pulmonary Rehabilitation
NMES + Pulmonary RehabilitationNMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks. Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.	Device	NMES + Pulmonary Rehabilitation
Pulmonary RehabilitationPulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.	Device	Pulmonary Rehabilitation

Primary outcome

Static postural balance
Time frame: Post-intervention (change after 8 weeks of training)
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of pressure displacement amplitude in the anteroposterior direction (COP) (cm).
Static postural balance
Time frame: Post-intervention (change after 8 weeks of training)
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the area of ellipse (AE) (cm2).
Static postural balance
Time frame: Post-intervention (change after 8 weeks of training)
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the velocity of displacement of center of pressure (COPvel) (cm/s).
Static postural balance
Time frame: Post-intervention (change after 8 weeks of training)
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of area of pressure and area of ellipse (AE) (cm2).

23 secondary outcomes

Static postural balance
Time frame: Post-intervention (change after 8 weeks of training)
Static and dynamic postural balance
Time frame: Post-intervention (change after 8 weeks of training)
Static and dynamic postural balance
Time frame: Post-intervention (change after 8 weeks of training)
Dynamic postural balance
Time frame: Post-intervention (change after 8 weeks of training)
Balance confidence questionnaire
Time frame: Post-intervention (change after 8 weeks of training)
Balance confidence questionnaire
Time frame: Post-intervention (change after 8 weeks of training)
Peripheral muscle strength
Time frame: Post-intervention (change after 8 weeks of training)
Respiratory muscle strength and inspiratory muscle endurance
Time frame: Post-intervention (change after 8 weeks of training)
Quadriceps femoris and diaphragm thickness
Time frame: Post-intervention (change after 8 weeks of training)
Submaximal level of functional capacity
Time frame: Post-intervention (change after 8 weeks of training)
Health-related quality of life at 8 week
Time frame: Post-intervention (change after 8 weeks of training)
Oxidant profile
Time frame: Post-intervention (change after 8 weeks of training)
Oxidant profile
Time frame: Post-intervention (change after 8 weeks of training)
Oxidant profile
Time frame: Post-intervention (change after 8 weeks of training)
Oxidant profile
Time frame: Post-intervention (change after 8 weeks of training)
Antioxidant profile
Time frame: Post-intervention (change after 8 weeks of training)
Antioxidant profile
Time frame: Post-intervention (change after 8 weeks of training)
Muscle damage
Time frame: Post-intervention (change after 8 weeks of training)
Muscle damage
Time frame: Post-intervention (change after 8 weeks of training)
Muscle damage
Time frame: Post-intervention (change after 8 weeks of training)
DNA damage
Time frame: Post-intervention (change after 8 weeks of training)
Endothelial function
Time frame: Post-intervention (change after 8 weeks of training)
Peripheral muscle resistance of the lower limbs
Time frame: Post-intervention (change after 8 weeks of training)

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 31 May 2023.
Derived from this study: PubMed 37580800Daros Dos Santos T, Pasqualoto AS, Cardoso DM, Da Cruz IBM, Moresco RN, Ferreira da Silveira A, Martins de Albuquerque I. Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2023 Aug 15;24(1):532. doi: 10.1186/s13063-023-07558-9.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.

Isabella Albuquerque, DSc study chair

Universidade Federal de Santa Maria

Tamires dos Santos, MSc principal investigator

Universidade Federal de Santa Maria

Aron Silveira, DSc study chair

Universidade Federal de Santa Maria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 15 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 31 May 2023. 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 Brazil. 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?

Static postural balance (time frame: Post-intervention (change after 8 weeks of training)). The study lists 4 primary outcomes in all. 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 NCT04387318, which also lists 1 linked publication.

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 31 May 2023.