Pulmonary Arterial HypertensionNCT03612115
Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension
A study testing Neuromuscular electrical stimulation in people with Pulmonary Arterial Hypertension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2015to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Orthopaedic problems
- Significant restrictive or obstructive pulmonary disease
- Acute cor pulmonale.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Neuromuscular electrical stimulation
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation intervention | Experimental | Neuromuscular electrical stimulation treatment Receives: Device: Neuromuscular electrical stimulation |
| Control | No intervention | No additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric muscle strength
Isometric muscle strength for knee extensors
Measured: Change from Baseline at 8 weeks
Secondary outcomes (15)
Isometric muscle strength
Isometric muscle strength for shoulder flexors and abductors
Measured: Change from Baseline at 8 weeks
Hand grip strength
Hand grip strength
Measured: Change from Baseline at 8 weeks
Quadriceps femoris muscle thickness
Measured: Change from Baseline at 8 weeks
Rectus femoris cross-sectional area
Measured: Change from Baseline at 8 weeks
Pulse wave velocity
Measured: Change from Baseline at 8 weeks
Six-Minute Walk Test
Measured: Change from Baseline at 8 weeks
Six-Minute Pegboard and Ring Test
Measured: Change from Baseline at 8 weeks
Sit-to-Stand Test
Measured: Change from Baseline at 8 weeks
Timed-Up and Go Test
Measured: 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.
Measured: Change from Baseline at 8 weeks
4-m Gait Speed Test
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Sep 2015
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Ozcan Kahraman, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612115
- Sponsor's protocol ID
- 2217-GOA
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Neuromuscular Electrical Stimulation in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT03612115
- Acronym / sponsor ID
- 2217-GOA
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation intervention | Experimental | Device: Neuromuscular electrical stimulationNeuromuscular electrical stimulation treatment |
| Control | No intervention | –No additional intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Orthopaedic problems
- Significant restrictive or obstructive pulmonary disease
- Acute cor pulmonale.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationNeuromuscular 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) | Device | Neuromuscular electrical stimulation intervention |
Primary outcome
Isometric muscle strength
Time frame: Change from Baseline at 8 weeks
Isometric muscle strength for knee extensors
15 secondary outcomes
Isometric muscle strength
Time frame: Change from Baseline at 8 weeks
Hand grip strength
Time frame: Change from Baseline at 8 weeks
Quadriceps femoris muscle thickness
Time frame: Change from Baseline at 8 weeks
Rectus femoris cross-sectional area
Time frame: Change from Baseline at 8 weeks
Pulse wave velocity
Time frame: Change from Baseline at 8 weeks
Six-Minute Walk Test
Time frame: Change from Baseline at 8 weeks
Six-Minute Pegboard and Ring Test
Time frame: Change from Baseline at 8 weeks
Sit-to-Stand Test
Time frame: Change from Baseline at 8 weeks
Timed-Up and Go Test
Time frame: Change from Baseline at 8 weeks
Activities-specific Balance Confidence Scale
Time frame: Change from Baseline at 8 weeks
4-m Gait Speed Test
Time frame: Change from Baseline at 8 weeks
Fatigue Impact Scale
Time frame: Change from Baseline at 8 weeks
International Physical Activity Questionnaire-Short Form
Time frame: Change from Baseline at 8 weeks
Milliken Activities of Daily Living Scale
Time frame: Change from Baseline at 8 weeks
Nottingham Health Profile
Time frame: Change from Baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation in people with Pulmonary Arterial Hypertension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric muscle strength (time frame: Change from Baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.