Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
- Conditions
- Pulmonary Hypertension
- Registration Number
- NCT02712294
- Lead Sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Borg scale in six-minute walk test change from baseline in Borg scale at 2 months analysis of Borg scale at end of test
Systolic blood pressure in six-minute walk test 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 change from baseline in diastolic blood pressure at 2 months analysis of diastolic blood pressure at end of test
Distance in six-minute walk test change from baseline in distance at 2 months analysis of distance
Oxygen saturation in six-minute walk test change from baseline in oxygen saturation at 2 months analysis of oxygen saturation at end of test
Heart rate in six-minute walk test change from baseline in heart rate at 2 months analysis of heart rate at end of test
- Secondary Outcome Measures
Name Time Method Forced vital capacity change from baseline at 2 months spirometric analysis
Forced expiratory volume in the first second change from baseline at 2 months spirometric analysis
The Medical Outcomes Study 36-item Short Form Health Survey change from baseline at 2 months The questionnaire covers 36 items, designed to assess health concepts
Ratio of forced expiratory volume in the first second and forced vital capacity change from baseline at 2 months spirometric analysis
Forced expiratory flow 25-75 % change from baseline at 2 months spirometric analysis
Trial Locations
- Locations (1)
Santa Casa of Sao Paulo Medical School
🇧🇷Sao Paulo, Brazil
Santa Casa of Sao Paulo Medical School🇧🇷Sao Paulo, Brazil