Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension

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

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 Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Device: Neuromuscular electrical stimulation

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35320
    • Dokuz Eylul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neuromuscular electrical stimulation intervention; Neuromuscular electrical stimulation treatment	Device: 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)
NO_INTERVENTION: Control; No additional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric muscle strength	Isometric muscle strength for knee extensors	Change from Baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-Minute Walk Test		Change from Baseline at 8 weeks
Isometric muscle strength	Isometric muscle strength for shoulder flexors and abductors	Change from Baseline at 8 weeks
Hand grip strength	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 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	The Activities-specific Balance Confidence Scale is a 16-item instrument designed to measure a patient's perceived level of confidence in performing common activities of daily living without losing balance and falling. The patient ranks his confidence to complete each item from 0% (no confidence) to 100% (complete confidence). Total score is calculated as sum score ranged from 0 to 100. Higher scores indicate higher balance confidence level.	Change from Baseline at 8 weeks
4-m Gait Speed Test		Change from Baseline at 8 weeks
Fatigue Impact Scale	The Fatigue Impact Scale is widely used to measure fatigue. It is a 40-item multidimensional scale measuring the physical, cognitive and social. Patients are asked to rate how much of a problem fatigue has caused them during the past month, including the day of testing, on a 5-point Likert-type scale, with response options ranging from 0 "no problem" to 4 "extreme problem". Higher scores indicate the greater level of fatigue (total score ranged from 0 to 160).	Change from Baseline at 8 weeks
International Physical Activity Questionnaire-Short Form	The International Physical Activity Questionnaire-Short Form has 7 items listing activities and requests estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known metabolic equivalents per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. Higher scores indicate higher physical activity level.	Change from Baseline at 8 weeks
Milliken Activities of Daily Living Scale	Milliken Activities of Daily Living Scale consists of 47 items including preparing meals, and eating (8 items), self-care (9 items), dressing oneself (8 items), manual manipulation of objects (9 items), house cleaning, and washing clothes (7 items), and other activities (6 items). For scoring the level of ability to perform each item, a 5-point scale, and for the level of necessity to perform these items, a 3-point scale is used. Total score can range from 0 to 705 points. Higher scores indicate less limitation in activities of daily living.	Change from Baseline at 8 weeks
Nottingham Health Profile	Health-related quality of life will be assessed using Nottingham Health Profile scale which is a general quality of life questionnaire that measures perceived health problems and their impact on normal daily activities. It has 38 items divided into six domains: energy level, pain, emotional reactions, sleep, social isolation and physical abilities. Items use yes/no answer format and each item is weighted. Total scores for each domain range from 0 to 100. Higher scores represent less quality of life in relevant domain.	Change from Baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): September 28, 2017
• Study Completion (ACTUAL): September 28, 2017

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (ACTUAL): August 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: 2217-GOA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No