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

NCT ID: NCT02712294

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group (GC)

The GC received standard ambulatory care, including routine exams and drug therapy. All patients were reassessed after the 2 month protocol.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type: OTHER

Interventions

Neuromuscular Electrical Stimulation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Profa. Dra. Vera Lúcia dos Santos Alves

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Santa Casa of Sao Paulo Medical School

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

Parece 517.472

Identifier Type: -

Identifier Source: org_study_id