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

NCT02712294 | Completed DMC

• 1 other identifier: Parece 517.472
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• The Medical Outcomes Study 36-item Short Form Health Survey

  change from baseline at 2 months

• Forced vital capacity

  change from baseline at 2 months

• Forced expiratory volume in the first second

  change from baseline at 2 months

• Forced expiratory flow 25-75 %

  change from baseline at 2 months

• Ratio of forced expiratory volume in the first second and forced vital capacity

  change from baseline at 2 months

Study Arms (2)

Control Group (GC)

NO INTERVENTION

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

NMES Group (GE)

EXPERIMENTAL

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

Interventions

Neuromuscular Electrical Stimulation OTHER

NMES Group (GE)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Santa Casa of Sao Paulo Medical School

São Paulo, 01221-020, Brazil

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 18, 2016
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 18, 2019

Record last verified: 2016-02

Locations

BR (1)