The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254159
• Other study ID #: ElifD
• Status: Completed
• Phase: N/A
• Start date: December 5, 2019
• Est. completion date: May 22, 2020

Study information

• Verified date: February 2022
• Source: Yeditepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 22, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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

Locations

Country	Name	City	State
Turkey	Kadiköy Municipality Social Life Center	Istanbul	Kadiköy

Sponsors (2)

Lead Sponsor	Collaborator
Yeditepe University	Kadikoy Municipality Social Life Center

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sit to Stand Test	Quadriceps muscle endurance will be evaluated with this test	8 weeks
Primary	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.	8 weeks
Primary	Six Minute Walking Test	Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.	8 weeks
Primary	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 Alpaydin et al.	8 weeks
Secondary	Modified Medical Research Council (MMRC) Dyspnea Scale	Perceived dyspnea which is any restrictions performing daily living activities will be measured by MMRC dyspnea scale.	8 weeks
Secondary	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).	8 weeks
Secondary	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.	8 weeks
Secondary	Pulmonary Function Test	Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers.	8 weeks
Secondary	Respiratory Muscle Strength Testing	The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength.	8 weeks