Pulmonary HypertensionNCT02712294
Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
A study testing Neuromuscular Electrical Stimulation in people with Pulmonary Hypertension, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity. Non-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Neuromuscular Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Dec 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females greater than or equal to 18 years of age, clinically stable with optimized drug therapy in the last 3 months, previously diagnosed with a mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization and who agreed to participate by signing an informed consent were included.
Who cannot join
- Exclusion criteria included a diagnosis of Down syndrome, orthopedic disease or neurologic or diagnoses, history of acute heart attack, use of beta-blockers, any urgent or elective surgical intervention during the implementation of the protocol, those who used assistive devices to ambulate or develop an infectious process during the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity.
Non-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable therapeutic approach in patients with functional limitations, particularly those that present with difficulty to perform exercise protocols.
Read more
Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality of life of patients with PH.
Material and methods: prospective randomized controlled study with a control group (GC, n9) and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk test (6MWT) were assessed before and after the NMES protocol.
Results: the GE presented with a significant improvement in distance walked in the 6MWT, cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and social aspects of the questionnaire Short Form Health Survey-36.
Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved exercise capacity, quality of life and lung function testing.
- Conditions
- Pulmonary Hypertension
- Being tested
- Neuromuscular Electrical Stimulation
- Keywords
- pulmonary hypertension, peripheral muscle electrostimulation, capacity of the exercises, quality of life
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationOther
| Study group | Role | What they receive |
|---|---|---|
| Control Group (GC) | No intervention | The GC received standard ambulatory care, including routine exams and drug therapy. All patients were reassessed after the 2 month protocol. |
| NMES Group (GE) | Experimental | Receiving the usual care and guidance on their illness, underwent 30 minute NMES sessions twice a week for two months using an electrostimulator. Specifically, 5 cm adhesive surface electrodes in four alternate channels on the Rectus Femoris (two channels the right and two on the left) were used to deliver two-phase symmetrical currents, with a rectangular pulse wave at a frequency of 35 Hz and pulse duration of 250 μ. The time of ascent and descent was one second, contraction time was four seconds and relaxation was eight seconds. Receives: Other: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance in six-minute walk test
analysis of distance
Measured: change from baseline in distance at 2 months
Oxygen saturation in six-minute walk test
analysis of oxygen saturation at end of test
Measured: change from baseline in oxygen saturation at 2 months
Systolic blood pressure in six-minute walk test
analysis of systolic blood pressure at end of test
Measured: change from baseline in systolic blood pressure at 2 months
Diastolic blood pressure in six-minute walk test
analysis of diastolic blood pressure at end of test
Measured: change from baseline in diastolic blood pressure at 2 months
Heart rate in six-minute walk test
analysis of heart rate at end of test
Measured: change from baseline in heart rate at 2 months
Borg scale in six-minute walk test
analysis of Borg scale at end of test
Measured: change from baseline in Borg scale at 2 months
Secondary outcomes (5)
The Medical Outcomes Study 36-item Short Form Health Survey
The questionnaire covers 36 items, designed to assess health concepts
Measured: change from baseline at 2 months
Forced vital capacity
spirometric analysis
Measured: change from baseline at 2 months
Forced expiratory volume in the first second
spirometric analysis
Measured: change from baseline at 2 months
Forced expiratory flow 25-75 %
spirometric analysis
Measured: change from baseline at 2 months
Ratio of forced expiratory volume in the first second and forced vital capacity
spirometric analysis
Measured: change from baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712294
- Sponsor's protocol ID
- Parece 517.472
- Status last verified
- Feb 2016
- First submitted
- 8 Mar 2016
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02712294
- Acronym / sponsor ID
- Parece 517.472
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, peripheral muscle electrostimulation, capacity of the exercises, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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.
Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity.
Non-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable therapeutic approach in patients with functional limitations, particularly those that present with difficulty to perform exercise protocols.
Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality of life of patients with PH.
Material and methods: prospective randomized controlled study with a control group (GC, n9) and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk test (6MWT) were assessed before and after the NMES protocol.
Results: the GE presented with a significant improvement in distance walked in the 6MWT, cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and social aspects of the questionnaire Short Form Health Survey-36.
Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved exercise capacity, quality of life and lung function testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (GC) | No intervention | –The GC received standard ambulatory care, including routine exams and drug therapy. All patients were reassessed after the 2 month protocol. |
| NMES Group (GE) | Experimental | Other: Neuromuscular Electrical StimulationReceiving the usual care and guidance on their illness, underwent 30 minute NMES sessions twice a week for two months using an electrostimulator. Specifically, 5 cm adhesive surface electrodes in four alternate channels on the Rectus Femoris (two channels the right and two on the left) were used to deliver two-phase symmetrical currents, with a rectangular pulse wave at a frequency of 35 Hz and pulse duration of 250 μ. The time of ascent and descent was one second, contraction time was four seconds and relaxation was eight seconds. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males and females greater than or equal to 18 years of age, clinically stable with optimized drug therapy in the last 3 months, previously diagnosed with a mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization and who agreed to participate by signing an informed consent were included.
Key exclusion criteria (1 listed)
- Exclusion criteria included a diagnosis of Down syndrome, orthopedic disease or neurologic or diagnoses, history of acute heart attack, use of beta-blockers, any urgent or elective surgical intervention during the implementation of the protocol, those who used assistive devices to ambulate or develop an infectious process during the study protocol.
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 |
|---|---|---|
| Neuromuscular Electrical Stimulation | Other | NMES Group (GE) |
Primary outcome
Distance in six-minute walk test
Time frame: change from baseline in distance at 2 months
analysis of distance
Oxygen saturation in six-minute walk test
Time frame: change from baseline in oxygen saturation at 2 months
analysis of oxygen saturation at end of test
Systolic blood pressure in six-minute walk test
Time frame: change from baseline in systolic blood pressure at 2 months
analysis of systolic blood pressure at end of test
Diastolic blood pressure in six-minute walk test
Time frame: change from baseline in diastolic blood pressure at 2 months
analysis of diastolic blood pressure at end of test
Heart rate in six-minute walk test
Time frame: change from baseline in heart rate at 2 months
analysis of heart rate at end of test
Borg scale in six-minute walk test
Time frame: change from baseline in Borg scale at 2 months
analysis of Borg scale at end of test
5 secondary outcomes
The Medical Outcomes Study 36-item Short Form Health Survey
Time frame: change from baseline at 2 months
Forced vital capacity
Time frame: change from baseline at 2 months
Forced expiratory volume in the first second
Time frame: change from baseline at 2 months
Forced expiratory flow 25-75 %
Time frame: change from baseline at 2 months
Ratio of forced expiratory volume in the first second and forced vital capacity
Time frame: change from baseline at 2 months
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 18 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation in people with Pulmonary Hypertension, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 18 Nov 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 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. 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?
Distance in six-minute walk test (time frame: change from baseline in distance at 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2019.