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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, peripheral muscle electrostimulation, capacity of the exercises, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Santa Casa of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group (GC)

NMES Group (GE)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Distance in six-minute walk test
analysis of distance
Oxygen saturation in six-minute walk test
analysis of oxygen saturation at end of test
Systolic blood pressure in six-minute walk test
analysis of systolic blood pressure at end of test
Diastolic blood pressure in six-minute walk test
analysis of diastolic blood pressure at end of test
Heart rate in six-minute walk test
analysis of heart rate at end of test
Borg scale in six-minute walk test
analysis of Borg scale at end of test

Secondary Outcome Measures

The Medical Outcomes Study 36-item Short Form Health Survey
The questionnaire covers 36 items, designed to assess health concepts
Forced vital capacity
spirometric analysis
Forced expiratory volume in the first second
spirometric analysis
Forced expiratory flow 25-75 %
spirometric analysis
Ratio of forced expiratory volume in the first second and forced vital capacity
spirometric analysis

Full Information

First Posted
March 8, 2016
Last Updated
November 14, 2019
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02712294
Brief Title
Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Official Title
Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, peripheral muscle electrostimulation, capacity of the exercises, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (GC)
Arm Type
No Intervention
Arm Description
The GC received standard ambulatory care, including routine exams and drug therapy. All patients were reassessed after the 2 month protocol.
Arm Title
NMES Group (GE)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neuromuscular Electrical Stimulation
Primary Outcome Measure Information:
Title
Distance in six-minute walk test
Description
analysis of distance
Time Frame
change from baseline in distance at 2 months
Title
Oxygen saturation in six-minute walk test
Description
analysis of oxygen saturation at end of test
Time Frame
change from baseline in oxygen saturation at 2 months
Title
Systolic blood pressure in six-minute walk test
Description
analysis of systolic blood pressure at end of test
Time Frame
change from baseline in systolic blood pressure at 2 months
Title
Diastolic blood pressure in six-minute walk test
Description
analysis of diastolic blood pressure at end of test
Time Frame
change from baseline in diastolic blood pressure at 2 months
Title
Heart rate in six-minute walk test
Description
analysis of heart rate at end of test
Time Frame
change from baseline in heart rate at 2 months
Title
Borg scale in six-minute walk test
Description
analysis of Borg scale at end of test
Time Frame
change from baseline in Borg scale at 2 months
Secondary Outcome Measure Information:
Title
The Medical Outcomes Study 36-item Short Form Health Survey
Description
The questionnaire covers 36 items, designed to assess health concepts
Time Frame
change from baseline at 2 months
Title
Forced vital capacity
Description
spirometric analysis
Time Frame
change from baseline at 2 months
Title
Forced expiratory volume in the first second
Description
spirometric analysis
Time Frame
change from baseline at 2 months
Title
Forced expiratory flow 25-75 %
Description
spirometric analysis
Time Frame
change from baseline at 2 months
Title
Ratio of forced expiratory volume in the first second and forced vital capacity
Description
spirometric analysis
Time Frame
change from baseline at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. 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.
Facility Information:
Facility Name
Santa Casa of Sao Paulo Medical School
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil

12. IPD Sharing Statement

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

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