The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Superimposed Neuromuscular Electrical Stimulation; Other: Quadriceps Strengthening; Behavioral: Patient Education Program; Other: Aerobic Exercise Training

• Registration Number: NCT04254159
• Lead Sponsor: Yeditepe University

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.

Study Timeline

• Study Start: 2019-12-05
• Primary Completion: 2020-02-02
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-02
• Study First Posted: 2020-02-05
• Study Completion: 2020-05-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular Electrical Stimulation Group	Patient Education Program	Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES
Neuromuscular Electrical Stimulation Group	Aerobic Exercise Training	Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES
Control Group	Patient Education Program	Asthma Education Aerobic Exercise Quadriceps Strengthening
Neuromuscular Electrical Stimulation Group	Superimposed Neuromuscular Electrical Stimulation	Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES
Control Group	Aerobic Exercise Training	Asthma Education Aerobic Exercise Quadriceps Strengthening
Control Group	Quadriceps Strengthening	Asthma Education Aerobic Exercise Quadriceps Strengthening

Primary Outcome Measures

Name	Time	Method
Sit to Stand Test	8 weeks	Quadriceps muscle endurance will be evaluated with this test
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.
Six Minute Walking Test	8 weeks	Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.
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

Name	Time	Method
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.
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.
Respiratory Muscle Strength Testing	8 weeks	The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength.
Pulmonary Function Test	8 weeks	Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers.
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).

Trial Locations

Locations (1)

Kadıköy Municipality Social Life Center; 🇹🇷 Istanbul, Kadıköy, Turkey