The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

NCT ID: NCT04254159

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2020-05-22

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Neuromuscular Electrical Stimulation Group

Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES

Group Type EXPERIMENTAL

Superimposed Neuromuscular Electrical Stimulation

Intervention Type 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.

Patient Education Program

Intervention Type 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

Intervention Type 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

Control Group

Asthma Education Aerobic Exercise Quadriceps Strengthening

Group Type ACTIVE_COMPARATOR

Quadriceps Strengthening

Intervention Type OTHER

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

Patient Education Program

Intervention Type 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

Intervention Type 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

Interventions

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Quadriceps Strengthening

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

Intervention Type 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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kadikoy Municipality Social Life Center

UNKNOWN

Sponsor Role collaborator

Yeditepe University

OTHER

Sponsor Role lead

Responsible Party

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Elif Develi

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kadıköy Municipality Social Life Center

Istanbul, Kadıköy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ElifD

Identifier Type: -

Identifier Source: org_study_id

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