Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension

NCT ID: NCT03612115

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2017-09-28

Brief Summary

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This study aimed to investigate the effects of neuromuscular electrical stimulation on peripheral muscles and other physical and psychosocial variables in patients with pulmonary arterial hypertension. This study was designed as an assessor-blind randomized controlled trial. Thirty-one patients with pulmonary arterial hypertension will be recruited. The participants will randomly divided two parallel groups as treatment and control. For the treatment group, neuromuscular electrical stimulation will be applied to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks. Control group will not be received any additional treatment, just given healthy life recommendations such as walking. The participants will be assessed before and after the treatment by a blind assessor to the group allocation. The outcome measure will be assessments of the upper and lower limb muscle strength, respiratory muscle strength, muscle cross-sectional area and thickness, pulse wave velocity, exercise capacity, walking speed, functional mobility and balance performances, balance confidence, fatigue perceptions, physical activity level, activities of daily living and quality of life.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Neuromuscular electrical stimulation intervention

Neuromuscular electrical stimulation treatment

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type DEVICE

Neuromuscular electrical stimulation to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks.

Device name: Four-channel Wireless Professional (DJO United Kingdom Ltd., Chattanooga, France)

Control

No additional intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neuromuscular electrical stimulation

Neuromuscular electrical stimulation to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks.

Device name: Four-channel Wireless Professional (DJO United Kingdom Ltd., Chattanooga, France)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Elevated pulmonary artery pressures measured by right heart catheterization
* New York Heart Association class II or III
* Stabile Pulmonary Arterial Hypertension-specific pharmaceutical therapy for 3 months

Exclusion Criteria

* Orthopaedic problems
* Significant restrictive or obstructive pulmonary disease
* Acute cor pulmonale.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Buse Ozcan Kahraman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dokuz Eylül University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2217-GOA

Identifier Type: -

Identifier Source: org_study_id

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