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Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension

Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02712294
Enrollment
30
Registered
2016-03-18
Start date
2014-06-30
Completion date
2016-12-31
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension, peripheral muscle electrostimulation, capacity of the exercises, quality of life

Brief 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. 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.

Interventions

OTHERNeuromuscular Electrical Stimulation

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Borg scale in six-minute walk testchange from baseline in Borg scale at 2 monthsanalysis of Borg scale at end of test
Distance in six-minute walk testchange from baseline in distance at 2 monthsanalysis of distance
Oxygen saturation in six-minute walk testchange from baseline in oxygen saturation at 2 monthsanalysis of oxygen saturation at end of test
Systolic blood pressure in six-minute walk testchange from baseline in systolic blood pressure at 2 monthsanalysis of systolic blood pressure at end of test
Diastolic blood pressure in six-minute walk testchange from baseline in diastolic blood pressure at 2 monthsanalysis of diastolic blood pressure at end of test
Heart rate in six-minute walk testchange from baseline in heart rate at 2 monthsanalysis of heart rate at end of test

Secondary

MeasureTime frameDescription
Forced vital capacitychange from baseline at 2 monthsspirometric analysis
Forced expiratory volume in the first secondchange from baseline at 2 monthsspirometric analysis
Forced expiratory flow 25-75 %change from baseline at 2 monthsspirometric analysis
Ratio of forced expiratory volume in the first second and forced vital capacitychange from baseline at 2 monthsspirometric analysis
The Medical Outcomes Study 36-item Short Form Health Surveychange from baseline at 2 monthsThe questionnaire covers 36 items, designed to assess health concepts

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026