Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension

NCT03612115 | Completed

• 1 other identifier: 2217-GOA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Isometric muscle strength

  Isometric muscle strength for knee extensors

  Change from Baseline at 8 weeks

Secondary Outcomes (15)

• Isometric muscle strength

  Change from Baseline at 8 weeks

• Hand grip strength

  Change from Baseline at 8 weeks

• Quadriceps femoris muscle thickness

  Change from Baseline at 8 weeks

• Rectus femoris cross-sectional area

  Change from Baseline at 8 weeks

• Pulse wave velocity

  Change from Baseline at 8 weeks

Study Arms (2)

Neuromuscular electrical stimulation intervention

EXPERIMENTAL

Neuromuscular electrical stimulation treatment

Device: Neuromuscular electrical stimulation

Control

NO INTERVENTION

No additional intervention

Interventions

Neuromuscular electrical stimulation 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)

Neuromuscular electrical stimulation intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Orthopaedic problems
• Significant restrictive or obstructive pulmonary disease
• Acute cor pulmonale.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Izmir, 35320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: September 1, 2015
• Primary Completion: September 28, 2017
• Study Completion: September 28, 2017
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

TU (1)