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NCT Number: NCT04254159

The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kadıköy Municipality Social Life Center

Istanbul, Kadıköy, 34736, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superimposed Neuromuscular Electrical Stimulation

Other

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 Strengthening

Other

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

patient education program

Behavioral

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 training

Other

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

Primary outcomes

  1. Sit to Stand Test

    Time frame: 8 weeks

    Quadriceps muscle endurance will be evaluated with this test

  2. 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.

  3. Six Minute Walking Test

    Time frame: 8 weeks

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

  4. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Collaborators

  • Kadikoy Municipality Social Life Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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