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The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Superimposed Neuromuscular Electrical Stimulation
Quadriceps Strengthening
Patient Education Program
Aerobic Exercise Training
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Asthma, Neuromuscular Electrical Stimulation, Quadriceps Muscle Strength, Quality of Life

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kadıköy Municipality Social Life Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromuscular Electrical Stimulation Group

Control Group

Arm Description

Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES

Asthma Education Aerobic Exercise Quadriceps Strengthening

Outcomes

Primary Outcome Measures

Sit to Stand Test
Quadriceps muscle endurance will be evaluated with this test
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.
Six Minute Walking Test
Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.
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.

Secondary Outcome Measures

Modified Medical Research Council (MMRC) Dyspnea Scale
Perceived dyspnea which is any restrictions performing daily living activities will be measured by MMRC dyspnea scale.
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 Up and Go Test
Time Up and Go Test (TUG) will be used to evaluate the risk for falling in older patients with asthma.
Pulmonary Function Test
Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers.
Respiratory Muscle Strength Testing
The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength.

Full Information

First Posted
February 2, 2020
Last Updated
February 9, 2022
Sponsor
Yeditepe University
Collaborators
Kadikoy Municipality Social Life Center
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1. Study Identification

Unique Protocol Identification Number
NCT04254159
Brief Title
The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
February 2, 2020 (Actual)
Study Completion Date
May 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University
Collaborators
Kadikoy Municipality Social Life Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Neuromuscular Electrical Stimulation, Quadriceps Muscle Strength, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Electrical Stimulation Group
Arm Type
Experimental
Arm Description
Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Asthma Education Aerobic Exercise Quadriceps Strengthening
Intervention Type
Other
Intervention Name(s)
Superimposed Neuromuscular Electrical Stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quadriceps Strengthening
Intervention Description
Quadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
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 Outcome Measure Information:
Title
Sit to Stand Test
Description
Quadriceps muscle endurance will be evaluated with this test
Time Frame
8 weeks
Title
Muscle Strength Test
Description
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
Title
Six Minute Walking Test
Description
Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.
Time Frame
8 weeks
Title
Asthma Quality of Life Scale (AQOL)
Description
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 Outcome Measure Information:
Title
Modified Medical Research Council (MMRC) Dyspnea Scale
Description
Perceived dyspnea which is any restrictions performing daily living activities will be measured by MMRC dyspnea scale.
Time Frame
8 weeks
Title
Physical Activity Questionnaire for Elderly (PASE)
Description
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
Title
Time Up and Go Test
Description
Time Up and Go Test (TUG) will be used to evaluate the risk for falling in older patients with asthma.
Time Frame
8 weeks
Title
Pulmonary Function Test
Description
Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers.
Time Frame
8 weeks
Title
Respiratory Muscle Strength Testing
Description
The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kadıköy Municipality Social Life Center
City
Istanbul
State/Province
Kadıköy
ZIP/Postal Code
34736
Country
Turkey

12. IPD Sharing Statement

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The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

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