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

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 Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Other: Neuromuscular Electrical Stimulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01221-020
    • Santa Casa of Sao Paulo Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group (GC); The GC received standard ambulatory care, including routine exams and drug therapy. All patients were reassessed after the 2 month protocol.
Experimental: NMES Group (GE); 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.	Other: Neuromuscular Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance in six-minute walk test	analysis of distance	change from baseline in distance at 2 months
Oxygen saturation in six-minute walk test	analysis of oxygen saturation at end of test	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	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	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	change from baseline in heart rate at 2 months
Borg scale in six-minute walk test	analysis of Borg scale at end of test	change from baseline in Borg scale at 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Medical Outcomes Study 36-item Short Form Health Survey	The questionnaire covers 36 items, designed to assess health concepts	change from baseline at 2 months
Forced vital capacity	spirometric analysis	change from baseline at 2 months
Forced expiratory volume in the first second	spirometric analysis	change from baseline at 2 months
Forced expiratory flow 25-75 %	spirometric analysis	change from baseline at 2 months
Ratio of forced expiratory volume in the first second and forced vital capacity	spirometric analysis	change from baseline at 2 months

Collaborators and Investigators

• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; pulmonary hypertension; peripheral muscle electrostimulation; capacity of the exercises
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: Parece 517.472