Clinical trial NCT03612115: Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension
Official title: Investigation of the Effects of Neuromuscular Electrical Stimulation in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Isometric muscle strength
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Isometric muscle strength
timeFrame: Change from Baseline at 8 weeks
measure: Hand grip strength
timeFrame: Change from Baseline at 8 weeks
measure: Quadriceps femoris muscle thickness
timeFrame: Change from Baseline at 8 weeks
measure: Rectus femoris cross-sectional area
timeFrame: Change from Baseline at 8 weeks
measure: Pulse wave velocity
timeFrame: Change from Baseline at 8 weeks
measure: Six-Minute Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: Six-Minute Pegboard and Ring Test
timeFrame: Change from Baseline at 8 weeks
measure: Sit-to-Stand Test
timeFrame: Change from Baseline at 8 weeks
measure: Timed-Up and Go Test
timeFrame: Change from Baseline at 8 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: Change from Baseline at 8 weeks
measure: 4-m Gait Speed Test
timeFrame: Change from Baseline at 8 weeks
measure: Fatigue Impact Scale
timeFrame: Change from Baseline at 8 weeks
measure: International Physical Activity Questionnaire-Short Form
timeFrame: Change from Baseline at 8 weeks
measure: Milliken Activities of Daily Living Scale
timeFrame: Change from Baseline at 8 weeks
measure: Nottingham Health Profile
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
References: