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Completed

NCT Number: NCT02712294

Impact of NMES 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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa of Sao Paulo Medical School

São Paulo, 01221-020, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuromuscular electrical stimulation

Other

Primary outcomes

  1. Distance in six-minute walk test

    Time frame: change from baseline in distance at 2 months

    analysis of distance

  2. Oxygen saturation in six-minute walk test

    Time frame: change from baseline in oxygen saturation at 2 months

    analysis of oxygen saturation at end of test

  3. Systolic blood pressure in six-minute walk test

    Time frame: change from baseline in systolic blood pressure at 2 months

    analysis of systolic blood pressure at end of test

  4. Diastolic blood pressure in six-minute walk test

    Time frame: change from baseline in diastolic blood pressure at 2 months

    analysis of diastolic blood pressure at end of test

  5. Heart rate in six-minute walk test

    Time frame: change from baseline in heart rate at 2 months

    analysis of heart rate at end of test

  6. Borg scale in six-minute walk test

    Time frame: change from baseline in Borg scale at 2 months

    analysis of Borg scale at end of test

Secondary outcomes

  1. The Medical Outcomes Study 36-item Short Form Health Survey

    Time frame: change from baseline at 2 months

    The questionnaire covers 36 items, designed to assess health concepts

  2. Forced vital capacity

    Time frame: change from baseline at 2 months

    spirometric analysis

  3. Forced expiratory volume in the first second

    Time frame: change from baseline at 2 months

    spirometric analysis

  4. Forced expiratory flow 25-75 %

    Time frame: change from baseline at 2 months

    spirometric analysis

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

    Time frame: change from baseline at 2 months

    spirometric analysis

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Official study title

Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2016
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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