The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

February 9, 2022 updated by: Elif Develi, Yeditepe University

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.

Study Overview

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kadıköy
      • Istanbul, Kadıköy, Turkey, 34736
        • Kadıköy Municipality Social Life Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Having stable asthma
  2. Participating to the study in a voluntary basis
  3. Being 65 - 75 years old
  4. Having 2 point or over score from "Modified Medical Research Council (MMRC)" Dyspnea Scale
  5. Being motivated to participate and follow exercise program

Exclusion Criteria:

  1. Having an asthma exacerbation in a last month
  2. Other respiratory problems
  3. Ischemic heart disease
  4. Congestive heart disease
  5. Pacemaker
  6. Acute Cor Pulmonale
  7. Neurological Diseases
  8. Osteoporosis
  9. Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2019

Primary Completion (Actual)

February 2, 2020

Study Completion (Actual)

May 22, 2020

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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