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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712294
• Other study ID #: Parece 517.472
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• Neuromuscular Electrical Stimulation

Locations

Country	Name	City	State
Brazil	Santa Casa of Sao Paulo Medical School	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance in six-minute walk test	analysis of distance	change from baseline in distance at 2 months
Primary	Oxygen saturation in six-minute walk test	analysis of oxygen saturation at end of test	change from baseline in oxygen saturation at 2 months
Primary	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
Primary	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
Primary	Heart rate in six-minute walk test	analysis of heart rate at end of test	change from baseline in heart rate at 2 months
Primary	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	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
Secondary	Forced vital capacity	spirometric analysis	change from baseline at 2 months
Secondary	Forced expiratory volume in the first second	spirometric analysis	change from baseline at 2 months
Secondary	Forced expiratory flow 25-75 %	spirometric analysis	change from baseline at 2 months
Secondary	Ratio of forced expiratory volume in the first second and forced vital capacity	spirometric analysis	change from baseline at 2 months