- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254159
The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma
The Effects of Neuromuscular Electrical Stimulation to Muscle Strength, Functional Capacity and Quality of Life in Older Patients With Asthma: Randomized Controlled Trial
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kadıköy
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Istanbul, Kadıköy, Turkey, 34736
- Kadıköy Municipality Social Life Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having an asthma exacerbation in a last month
- Other respiratory problems
- Ischemic heart disease
- Congestive heart disease
- Pacemaker
- Acute Cor Pulmonale
- Neurological Diseases
- Osteoporosis
- Smoking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neuromuscular Electrical Stimulation Group
Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES
|
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.
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.
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
|
Active Comparator: Control Group
Asthma Education Aerobic Exercise Quadriceps Strengthening
|
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.
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
Quadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sit to Stand Test
Time Frame: 8 weeks
|
Quadriceps muscle endurance will be evaluated with this test
|
8 weeks
|
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.
|
8 weeks
|
Six Minute Walking Test
Time Frame: 8 weeks
|
Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.
|
8 weeks
|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Medical Research Council (MMRC) Dyspnea Scale
Time Frame: 8 weeks
|
Perceived dyspnea which is any restrictions performing daily living activities will be measured by MMRC dyspnea scale.
|
8 weeks
|
Physical Activity Questionnaire for Elderly (PASE)
Time Frame: 8 weeks
|
We will assess the physical activity status of the oler patients with asthma by using Physical Activity Questionnaire for Elderly (PASE).
|
8 weeks
|
Time Up and Go Test
Time Frame: 8 weeks
|
Time Up and Go Test (TUG) will be used to evaluate the risk for falling in older patients with asthma.
|
8 weeks
|
Pulmonary Function Test
Time Frame: 8 weeks
|
Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers.
|
8 weeks
|
Respiratory Muscle Strength Testing
Time Frame: 8 weeks
|
The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ElifD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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