The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Neuromuscular Electrical Stimulation to Muscle Strength, Functional Capacity and Quality of Life in Older Patients With Asthma: Randomized Controlled Trial

Conditions
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Asthma

Intervention / Treatment
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* Other: Superimposed Neuromuscular Electrical Stimulation
* Other: Quadriceps Strengthening
* Behavioral: Patient Education Program
* Other: Aerobic Exercise Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular Electrical Stimulation Group<br>Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES | Other: Superimposed Neuromuscular Electrical Stimulation<br>* 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.<br>Behavioral: Patient Education Program<br>* 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.<br>Other: Aerobic Exercise Training<br>* 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<br>|
| Active Comparator: Control Group<br>Asthma Education Aerobic Exercise Quadriceps Strengthening | Other: Quadriceps Strengthening<br>* Quadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks.<br>Behavioral: Patient Education Program<br>* 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.<br>Other: Aerobic Exercise Training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sit to Stand Test | Quadriceps muscle endurance will be evaluated with this test | 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. | 8 weeks | 
| Six Minute Walking Test | Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers. | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Medical Research Council (MMRC) Dyspnea Scale | 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) | 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 Up and Go Test (TUG) will be used to evaluate the risk for falling in older patients with asthma. | 8 weeks | 
| Pulmonary Function Test | Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers. | 8 weeks | 
| Respiratory Muscle Strength Testing | The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quadriceps Muscle Strength, Asthma, Neuromuscular Electrical Stimulation, Quality of Life