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Clinical Trials/NCT03612115
NCT03612115
Completed
N/A

Investigation of the Effects of Neuromuscular Electrical Stimulation in Patients With Pulmonary Arterial Hypertension

Dokuz Eylul University1 site in 1 country31 target enrollmentSeptember 1, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
Dokuz Eylul University
Enrollment
31
Locations
1
Primary Endpoint
Isometric muscle strength
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2015
End Date
September 28, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Buse Ozcan Kahraman

Principal Investigator

Dokuz Eylul University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Isometric muscle strength

Time Frame: Change from Baseline at 8 weeks

Isometric muscle strength for knee extensors

Secondary Outcomes

  • Six-Minute Pegboard and Ring Test(Change from Baseline at 8 weeks)
  • Sit-to-Stand Test(Change from Baseline at 8 weeks)
  • Timed-Up and Go Test(Change from Baseline at 8 weeks)
  • Six-Minute Walk Test(Change from Baseline at 8 weeks)
  • 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)
  • Activities-specific Balance Confidence Scale(Change from Baseline at 8 weeks)
  • 4-m Gait Speed Test(Change from Baseline at 8 weeks)
  • Fatigue Impact Scale(Change from Baseline at 8 weeks)
  • International Physical Activity Questionnaire-Short Form(Change from Baseline at 8 weeks)
  • Milliken Activities of Daily Living Scale(Change from Baseline at 8 weeks)
  • Nottingham Health Profile(Change from Baseline at 8 weeks)

Study Sites (1)

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