Clinical trial NCT02712294: Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Official title: Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
peripheral muscle electrostimulation
capacity of the exercises
quality of life
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Distance in six-minute walk test
timeFrame: change from baseline in distance at 2 months
measure: Oxygen saturation in six-minute walk test
timeFrame: change from baseline in oxygen saturation at 2 months
measure: Systolic blood pressure in six-minute walk test
timeFrame: change from baseline in systolic blood pressure at 2 months
measure: Diastolic blood pressure in six-minute walk test
timeFrame: change from baseline in diastolic blood pressure at 2 months
measure: Heart rate in six-minute walk test
timeFrame: change from baseline in heart rate at 2 months
measure: Borg scale in six-minute walk test
timeFrame: change from baseline in Borg scale at 2 months
Secondary outcomes:
measure: The Medical Outcomes Study 36-item Short Form Health Survey
timeFrame: change from baseline at 2 months
measure: Forced vital capacity
timeFrame: change from baseline at 2 months
measure: Forced expiratory volume in the first second
timeFrame: change from baseline at 2 months
measure: Forced expiratory flow 25-75 %
timeFrame: change from baseline at 2 months
measure: Ratio of forced expiratory volume in the first second and forced vital capacity
timeFrame: change from baseline at 2 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Santa Casa of Sao Paulo Medical School
Study officials:
References: