The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Dec 2019
Shorter than P25 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2019
CompletedFirst Submitted
Initial submission to the registry
February 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2020
CompletedFebruary 10, 2022
February 1, 2022
2 months
February 2, 2020
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Sit to Stand Test
Quadriceps muscle endurance will be evaluated with this test
8 weeks
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
Six Minute Walking Test
Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.
8 weeks
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.
8 weeks
Secondary Outcomes (5)
Modified Medical Research Council (MMRC) Dyspnea Scale
8 weeks
Physical Activity Questionnaire for Elderly (PASE)
8 weeks
Time Up and Go Test
8 weeks
Pulmonary Function Test
8 weeks
Respiratory Muscle Strength Testing
8 weeks
Study Arms (2)
Neuromuscular Electrical Stimulation Group
EXPERIMENTALAsthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES
Control Group
ACTIVE COMPARATORAsthma Education Aerobic Exercise Quadriceps Strengthening
Interventions
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 strength training will be done with resistive elastics bands for 3 days a week for eight weeks.
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yeditepe Universitylead
- Kadikoy Municipality Social Life Centercollaborator
Study Sites (1)
Kadıköy Municipality Social Life Center
Istanbul, Kadıköy, 34736, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
February 2, 2020
First Posted
February 5, 2020
Study Start
December 5, 2019
Primary Completion
February 2, 2020
Study Completion
May 22, 2020
Last Updated
February 10, 2022
Record last verified: 2022-02