AsthmaNCT04254159
The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma
A study testing Superimposed Neuromuscular Electrical Stimulation, Quadriceps Strengthening and Patient Education Program in people with Asthma, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the randomized controlled study is to investigate the effects of NMES superimposed on voluntary contraction combined with patient education and exercise training program in patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Superimposed Neuromuscular Electrical Stimulation, Quadriceps Strengthening and Patient Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2019to 22 May 2020
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Having stable asthma
- Participating to the study in a voluntary basis
- Being 65 - 75 years old
- Having 2 point or over score from "Modified Medical Research Council (MMRC)" Dyspnea Scale
- Being motivated to participate and follow exercise program
Who cannot join
- Having an asthma exacerbation in a last month
- Other respiratory problems
- Ischemic heart disease
- Congestive heart disease
- Pacemaker
- Acute Cor Pulmonale
Show all 9Show fewer
- Neurological Diseases
- Osteoporosis
- Smoking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kadıköy Municipality Social Life Center
Istanbul, Kadıköy, 34736
About this study
Official title: The Effects of Neuromuscular Electrical Stimulation to Muscle Strength, Functional Capacity and Quality of Life in Older Patients With Asthma: Randomized Controlled Trial
The aim of the randomized controlled study is to investigate the effects of NMES superimposed on voluntary contraction combined with patient education and exercise training program in patients with chronic obstructive pulmonary disease.
Read the detailed description
When initial assessments will be completed, patients will be assigned to one of two possible sequences by simple randomization: Superimposed NMES group (SG) or control group (CG).
All volunteers will receive an COPD patient education program for once and conventional physiotherapy exercise program for COPD with the duration of 8 weeks. Additionally, superimposed NMES will be applied on quadriceps muscle of both limbs at the same time with voluntarily contraction of quadriceps muscle in SG.
All patients will be assessed in terms of functional capacity, pulmonary functions, quadriceps muscle endurance and strength, dyspnea, respiratory muscle strength and quality of life at the baseline and at the end of study. Data will be collected from all the patients at baseline and at the end of study (8 weeks) by the same physiotherapist who also will supervise the exercise sessions.
- Conditions
- Asthma
- Being tested
- Superimposed Neuromuscular Electrical Stimulation, Quadriceps Strengthening, Patient Education Program, Aerobic Exercise Training
- Keywords
- Asthma, Neuromuscular Electrical Stimulation, Quadriceps Muscle Strength, Quality of Life
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superimposed Neuromuscular Electrical StimulationOther
NMES will be applied during each strengthening exercise session. A dual channel NMES stimulation device will be used with biphasic symmetric constant current impulses with a pulse width 300ms, a frequency of 50 Hz and a duty cycle of 10s on and 20s off protocol for 3 days a week for eight weeks.
Quadriceps StrengtheningOther
Quadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks.
Patient Education ProgramBehavioural
The aim of patient education is to increase awareness of patients about COPD and develop skills to better manage their disease. The patient education will be performed at least once via face to face interview. Education topics will be covered basic information about COPD, environmental risk factors, monitoring and managing the signs and symptoms of their disease, energy conservation techniques and relaxation positions to reduce dyspnea and usage of a specific inhaler.
Aerobic Exercise TrainingOther
Exercise training will be comprised of cardiovascular endurance training with cycle ergometer and lower extremity strength training. The exercises will be done 3 days a week at the clinic under the supervision of physiotherapist. Total duration of exercise training will last for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Electrical Stimulation Group | Experimental | Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES Receives: Other: Superimposed Neuromuscular Electrical Stimulation; Behavioral: Patient Education Program; Other: Aerobic Exercise Training |
| Control Group | Active comparator | Asthma Education Aerobic Exercise Quadriceps Strengthening Receives: Other: Quadriceps Strengthening; Behavioral: Patient Education Program; Other: Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit to Stand Test
Quadriceps muscle endurance will be evaluated with this test
Measured: 8 weeks
Muscle Strength Test
Jtech Commander Power Track Muscle Testing Dynamometer, USA which quantifies muscle power will be used to assess the maximum voluntary contractions of quadriceps muscle in pound meter.
Measured: 8 weeks
Six Minute Walking Test
Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.
Measured: 8 weeks
Asthma Quality of Life Scale (AQOL)
Asthma quality of life questionnaire will utilize to assess quality of life of participants over two weeks prior to interview which is validated in Turkish population by Alpaydın et al.
Measured: 8 weeks
Secondary outcomes (5)
Modified Medical Research Council (MMRC) Dyspnea Scale
Perceived dyspnea which is any restrictions performing daily living activities will be measured by MMRC dyspnea scale.
Measured: 8 weeks
Physical Activity Questionnaire for Elderly (PASE)
We will assess the physical activity status of the oler patients with asthma by using Physical Activity Questionnaire for Elderly (PASE).
Measured: 8 weeks
Time Up and Go Test
Time Up and Go Test (TUG) will be used to evaluate the risk for falling in older patients with asthma.
Measured: 8 weeks
Pulmonary Function Test
Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers.
Measured: 8 weeks
Respiratory Muscle Strength Testing
The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start5 Dec 2019
- Primary completion2 Feb 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Kadikoy Municipality Social Life Center
- Responsible party
- Principal investigator, Elif Develi, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254159
- Sponsor's protocol ID
- ElifD
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2020
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neuromuscular Electrical Stimulation to Muscle Strength, Functional Capacity and Quality of Life in Older Patients With Asthma: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04254159
- Acronym / sponsor ID
- ElifD
- Conditions
- Asthma
- Keywords
- Asthma, Neuromuscular Electrical Stimulation, Quadriceps Muscle Strength, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Kadikoy Municipality Social Life Center
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 5 Feb 2020 (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.
The aim of the randomized controlled study is to investigate the effects of NMES superimposed on voluntary contraction combined with patient education and exercise training program in patients with chronic obstructive pulmonary disease.
Detailed description
When initial assessments will be completed, patients will be assigned to one of two possible sequences by simple randomization: Superimposed NMES group (SG) or control group (CG).
All volunteers will receive an COPD patient education program for once and conventional physiotherapy exercise program for COPD with the duration of 8 weeks. Additionally, superimposed NMES will be applied on quadriceps muscle of both limbs at the same time with voluntarily contraction of quadriceps muscle in SG.
All patients will be assessed in terms of functional capacity, pulmonary functions, quadriceps muscle endurance and strength, dyspnea, respiratory muscle strength and quality of life at the baseline and at the end of study. Data will be collected from all the patients at baseline and at the end of study (8 weeks) by the same physiotherapist who also will supervise the exercise sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Electrical Stimulation Group | Experimental | Other: Superimposed Neuromuscular Electrical Stimulation, Behavioral: Patient Education Program, Other: Aerobic Exercise TrainingAsthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES |
| Control Group | Active comparator | Other: Quadriceps Strengthening, Behavioral: Patient Education Program, Other: Aerobic Exercise TrainingAsthma Education Aerobic Exercise Quadriceps Strengthening |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Having stable asthma
- Participating to the study in a voluntary basis
- Being 65 - 75 years old
- Having 2 point or over score from "Modified Medical Research Council (MMRC)" Dyspnea Scale
- Being motivated to participate and follow exercise program
Key exclusion criteria (9 listed)
- Having an asthma exacerbation in a last month
- Other respiratory problems
- Ischemic heart disease
- Congestive heart disease
- Pacemaker
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 |
|---|---|---|
| Superimposed Neuromuscular Electrical StimulationNMES will be applied during each strengthening exercise session. A dual channel NMES stimulation device will be used with biphasic symmetric constant current impulses with a pulse width 300ms, a frequency of 50 Hz and a duty cycle of 10s on and 20s off protocol for 3 days a week for eight weeks. | Other | Neuromuscular Electrical Stimulation Group |
| Quadriceps StrengtheningQuadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks. | Other | Control Group |
| Patient Education ProgramThe aim of patient education is to increase awareness of patients about COPD and develop skills to better manage their disease. The patient education will be performed at least once via face to face interview. Education topics will be covered basic information about COPD, environmental risk factors, monitoring and managing the signs and symptoms of their disease, energy conservation techniques and relaxation positions to reduce dyspnea and usage of a specific inhaler. | Behavioural | Control Group, Neuromuscular Electrical Stimulation Group |
| Aerobic Exercise TrainingExercise training will be comprised of cardiovascular endurance training with cycle ergometer and lower extremity strength training. The exercises will be done 3 days a week at the clinic under the supervision of physiotherapist. Total duration of exercise training will last for 8 weeks | Other | Control Group, Neuromuscular Electrical Stimulation Group |
Primary outcome
Sit to Stand Test
Time frame: 8 weeks
Quadriceps muscle endurance will be evaluated with this test
Muscle Strength Test
Time frame: 8 weeks
Jtech Commander Power Track Muscle Testing Dynamometer, USA which quantifies muscle power will be used to assess the maximum voluntary contractions of quadriceps muscle in pound meter.
Six Minute Walking Test
Time frame: 8 weeks
Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.
Asthma Quality of Life Scale (AQOL)
Time frame: 8 weeks
Asthma quality of life questionnaire will utilize to assess quality of life of participants over two weeks prior to interview which is validated in Turkish population by Alpaydın et al.
5 secondary outcomes
Modified Medical Research Council (MMRC) Dyspnea Scale
Time frame: 8 weeks
Physical Activity Questionnaire for Elderly (PASE)
Time frame: 8 weeks
Time Up and Go Test
Time frame: 8 weeks
Pulmonary Function Test
Time frame: 8 weeks
Respiratory Muscle Strength Testing
Time frame: 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 10 Feb 2022.
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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 Superimposed Neuromuscular Electrical Stimulation, Quadriceps Strengthening and Patient Education Program in people with Asthma, run by Yeditepe 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 5 inclusion and 9 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 10 Feb 2022. 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?
Sit to Stand Test (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 10 Feb 2022.