The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

Sponsor
Yeditepe University (Other)
Overall Status
Completed
CT.gov ID
NCT04254159
Collaborator
Kadikoy Municipality Social Life Center (Other)
24
1
2
5.6
4.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Superimposed Neuromuscular Electrical Stimulation
  • Other: Quadriceps Strengthening
  • Behavioral: Patient Education Program
  • Other: Aerobic Exercise Training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effects of Neuromuscular Electrical Stimulation to Muscle Strength, Functional Capacity and Quality of Life in Older Patients With Asthma: Randomized Controlled Trial
Actual Study Start Date :
Dec 5, 2019
Actual Primary Completion Date :
Feb 2, 2020
Actual Study Completion Date :
May 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Neuromuscular Electrical Stimulation Group

Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES

Other: Superimposed 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.

Behavioral: Patient 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.

Other: Aerobic 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

Active Comparator: Control Group

Asthma Education Aerobic Exercise Quadriceps Strengthening

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

Behavioral: Patient 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.

Other: Aerobic 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

Outcome Measures

Primary Outcome Measures

  1. Sit to Stand Test [8 weeks]

    Quadriceps muscle endurance will be evaluated with this test

  2. Muscle Strength Test [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 [8 weeks]

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

  4. Asthma Quality of Life Scale (AQOL) [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 Outcome Measures

  1. Modified Medical Research Council (MMRC) Dyspnea Scale [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) [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 [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 [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 [8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 75 Years
Sexes Eligible for Study:
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:
  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kadıköy Municipality Social Life Center Istanbul Kadıköy Turkey 34736

Sponsors and Collaborators

  • Yeditepe University
  • Kadikoy Municipality Social Life Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elif Develi, Physiotherapist, Yeditepe University
ClinicalTrials.gov Identifier:
NCT04254159
Other Study ID Numbers:
  • ElifD
First Posted:
Feb 5, 2020
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elif Develi, Physiotherapist, Yeditepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022