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Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neuromuscular electrical stimulation intervention

Control

Arm Description

Neuromuscular electrical stimulation treatment

No additional intervention

Outcomes

Primary Outcome Measures

Isometric muscle strength
Isometric muscle strength for knee extensors

Secondary Outcome Measures

Isometric muscle strength
Isometric muscle strength for shoulder flexors and abductors
Hand grip strength
Hand grip strength
Quadriceps femoris muscle thickness
Rectus femoris cross-sectional area
Pulse wave velocity
Six-Minute Walk Test
Six-Minute Pegboard and Ring Test
Sit-to-Stand Test
Timed-Up and Go Test
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.
4-m Gait Speed Test
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).
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.
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.
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.

Full Information

First Posted
July 27, 2018
Last Updated
August 1, 2018
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03612115
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 28, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular electrical stimulation intervention
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
No additional intervention
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Isometric muscle strength
Description
Isometric muscle strength for knee extensors
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Isometric muscle strength
Description
Isometric muscle strength for shoulder flexors and abductors
Time Frame
Change from Baseline at 8 weeks
Title
Hand grip strength
Description
Hand grip strength
Time Frame
Change from Baseline at 8 weeks
Title
Quadriceps femoris muscle thickness
Time Frame
Change from Baseline at 8 weeks
Title
Rectus femoris cross-sectional area
Time Frame
Change from Baseline at 8 weeks
Title
Pulse wave velocity
Time Frame
Change from Baseline at 8 weeks
Title
Six-Minute Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
Six-Minute Pegboard and Ring Test
Time Frame
Change from Baseline at 8 weeks
Title
Sit-to-Stand Test
Time Frame
Change from Baseline at 8 weeks
Title
Timed-Up and Go Test
Time Frame
Change from Baseline at 8 weeks
Title
Activities-specific Balance Confidence Scale
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
4-m Gait Speed Test
Time Frame
Change from Baseline at 8 weeks
Title
Fatigue Impact Scale
Description
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).
Time Frame
Change from Baseline at 8 weeks
Title
International Physical Activity Questionnaire-Short Form
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Milliken Activities of Daily Living Scale
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Nottingham Health Profile
Description
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.
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Dokuz Eylül University
City
Izmir
ZIP/Postal Code
35320
Country
Turkey

12. IPD Sharing Statement

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Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension

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