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CompletedNCT04254159Updated Feb 10, 2022

The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

An interventional study of Superimposed Neuromuscular Electrical Stimulation and Quadriceps Strengthening in Asthma, sponsored by Yeditepe University. Completed at 1 site in Turkey. Open to participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by Yeditepe University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Neuromuscular Electrical Stimulation
  • Quadriceps Muscle Strength
  • Quality of Life
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 24 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Yeditepe University is the lead sponsor of 127 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Neuromuscular Electrical Stimulation Group

    Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES

    Other: Superimposed Neuromuscular Electrical Stimulation · Behavioral: Patient Education Program · Other: Aerobic Exercise Training

  • Active comparator
    Control Group

    Asthma Education Aerobic Exercise Quadriceps Strengthening

    Other: Quadriceps Strengthening · Behavioral: Patient Education Program · Other: Aerobic Exercise Training

Interventions

  • OtherSuperimposed Neuromuscular Electrical Stimulation

    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.

  • OtherQuadriceps Strengthening

    Quadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks.

  • BehavioralPatient Education Program

    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.

  • OtherAerobic Exercise Training

    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

06

What researchers measure

Primary outcomes

  1. Sit to Stand Test

    Quadriceps muscle endurance will be evaluated with this test

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. Six Minute Walking Test

    Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. Modified Medical Research Council (MMRC) Dyspnea Scale

    Perceived dyspnea which is any restrictions performing daily living activities will be measured by MMRC dyspnea scale.

    Time frame: 8 weeks

  2. 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).

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. Pulmonary Function Test

    Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers.

    Time frame: 8 weeks

  5. Respiratory Muscle Strength Testing

    The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength.

    Time frame: 8 weeks

07

Study locations

1 site
  • Kadıköy Municipality Social Life Center
    Istanbul, Kadıköy 34736, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04254159
Lead sponsor
Yeditepe University
Collaborators
Kadikoy Municipality Social Life Center
Responsible party
Elif Develi (Physiotherapist, Yeditepe University) — Principal investigator
First posted
Feb 5, 2020
Start date
Dec 5, 2019
Primary completion
Feb 2, 2020
Completion
May 22, 2020
Last update
Feb 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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