Investigation of the Effects of Neuromuscular Electrical Stimulation in Patients With Pulmonary Arterial Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Isometric muscle strength
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Neuromuscular electrical stimulation intervention
Neuromuscular electrical stimulation treatment
Intervention: Neuromuscular electrical stimulation (Device)
Control
No additional intervention
Outcomes
Primary Outcomes
Isometric muscle strength
Time Frame: Change from Baseline at 8 weeks
Isometric muscle strength for knee extensors
Secondary Outcomes
- 4-m Gait Speed 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)
- Six-Minute Walk Test(Change from Baseline at 8 weeks)
- 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)
- Activities-specific Balance Confidence Scale(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)
Investigators
Buse Ozcan Kahraman
Principal Investigator
Dokuz Eylul University