Pulmonary RehabilitationNEMS for COPDNCT05838911
Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease
A study testing Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) in people with Pulmonary Rehabilitation and Chronic Obstructive Lung Disease, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Background: Patients with COPD often experience skeletal muscle dysfunction. For those who are unable or unwilling to undertake physical training, neuromuscular electrical stimulation (NMES) may provide an alternative method of exercise training. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Pulmonary Rehabilitation, Chronic Obstructive Lung Disease, Neuromuscular Electrical Stimulation
- What is being tested?
- Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2023to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- A diagnosis of COPD with FEV1/FVC <50% predicted as per the GOLD guidelines.
- Self-reported dyspnea and/or arm fatigue during at least one activity of daily living that required arm exercise.
- Dyspnea and/or physical activity fatigue were self-reported by the Borg Scale.
- Before entering in the study, all patients had their pulmonary function optimized with long-acting bronchodilators and corticosteroids.
Who cannot join
- • Patients with unstable angina pectoris.
- Progressive ventricular dysrhythmia.
- Intermittent claudication.
- Implanted cardiac pacemakers.
- Uncontrolled diabetes mellitus.
- Peripheral vascular disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt
Qina
About this study
Background: Patients with COPD often experience skeletal muscle dysfunction. For those who are unable or unwilling to undertake physical training, neuromuscular electrical stimulation (NMES) may provide an alternative method of exercise training.
Objective: To investigate the effects of adding neuromuscular electrical stimulation of gluteus maximus, quadriceps and calf muscles to chest physiotherapy, compared to chest physiotherapy alone, on muscle strength (gluteus max., quadriceps, calf muscles), femoral blood flow physical and pulmonary function in severe COPD Patients.
Read the detailed description
Material and methods: This study include a group of 60 patients (30 males and 30 females) diagnosed with severe COPD), their age is ranged 65-75 years, they will be randomly divided into two groups; study group (A) 30 patients and study group (B) 30 patients. Study group (A): The patients in this group will receive the chest physiotherapy program for 20 min each day, for five days a week for 8 consecutive weeks. Study group (B): The patients in this group will receive the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, calf muscles, performed for 30 min /day for five days a week for 8 consecutive weeks. Femoral blood Flow, gluteus maximus, quadriceps and calf muscles strength and pulmonary function (FEV1/FVC) will be measured for both groups pre and post-treatment, then after 3 months follow up.
- Conditions
- Pulmonary Rehabilitation, Chronic Obstructive Lung Disease, Neuromuscular Electrical Stimulation, Pulmonary Function (FEV1/FVC)
- Being tested
- Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES), Control Group Chest physical therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)Other
Also called Chest physical therapy plus NMES
The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, and calf muscles performed for 30 min /day for five days a week for 8 consecutive weeks.
Control Group Chest physical therapyOther
Also called Chest physical therapy
The patients in this group were received the chest physiotherapy program for 20 min each day, for five days a week for 8 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The patients in this group were received the chest physiotherapy program for 20 min each day, for five days a week for8 consecutive weeks. Receives: Other: Control Group Chest physical therapy |
| Study Group | Experimental | The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) of gluteus max., quadriceps, and calf muscles performed for 30 min /day for five days a week for 8 consecutive weeks. Receives: Other: Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walking test (Physical function assessment
The six-minute walking distance (6MWD) was measured according to a standardized protocol.
- Subjects were instructed to walk at their own pace along a 34.5-m corridor from one end to the other, covering as much ground as possible in the allotted time.
- Subjects were allowed to stop and rest during the test, but they were instructed to resume walking as soon as they felt able to do
Measured: change from baseline to 8 weeks after intervention and 3 months as a follow-up
Pulmonary function test
Pulmonary capacity and respiratory muscle functions will be assessed using the CPFS/D USB™ 187 Spirometer (Medical Graphics-MGC, St. Paul, MN, USA) with airflow being measured by a 188 calibrated Pitot tube (PreVent, Pneumotach). The participant completed at least three acceptable maximal forced and slow expiratory maneuvers after 15 min the inhalation of 400 mg of salbutamol 190 via a metered-dose inhaler. Forced vital capacity (FVC, L), forced expiratory volume in one second (FEV1, L), FEV1/ FVC, and inspiratory capacity (IC) will be measured according to American Thoracic Society standards
Measured: change from baseline to 8 weeks after intervention and 3 months as a follow-up
Muscle strength measurement
To determine the maximal muscle strength the Lafayette manual muscle test system (USER MANUAL) (MMT) Model 01163, White Plains, New York (10602) of gluteus maximus, quadriceps and calf muscles will be measured on right lower limb.
Measured: change from baseline to 8 weeks after intervention and 3 months as a follow-up
Secondary outcomes (1)
Blood flow velocimetry measurement
To evaluate changes in peripheral perfusion. The standard pulsed-wave Doppler velocimetry of the right femoral artery was performed using sonos 2000 echograph (Philips Envisor )
Measured: change from baseline to 8 weeks after intervention and 3 months as a follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start2 Apr 2023
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary RehabilitationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- South Valley University
- Responsible party
- Principal investigator, Ahmed Samir Abdelkhalik Youssef, Beni-Suef University
- Investigators
- Ibrahim I. I Abu zaid, PhD, Study director, Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838911
- Sponsor's protocol ID
- BeniSuefU_1
- Acronym
- NEMS for COPD
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT05838911
- Acronym / sponsor ID
- NEMS for COPD / BeniSuefU_1
- Conditions
- Pulmonary Rehabilitation, Chronic Obstructive Lung Disease, Neuromuscular Electrical Stimulation, Pulmonary Function (FEV1/FVC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- South Valley University
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Patients with COPD often experience skeletal muscle dysfunction. For those who are unable or unwilling to undertake physical training, neuromuscular electrical stimulation (NMES) may provide an alternative method of exercise training.
Objective: To investigate the effects of adding neuromuscular electrical stimulation of gluteus maximus, quadriceps and calf muscles to chest physiotherapy, compared to chest physiotherapy alone, on muscle strength (gluteus max., quadriceps, calf muscles), femoral blood flow physical and pulmonary function in severe COPD Patients.
Detailed description
Material and methods: This study include a group of 60 patients (30 males and 30 females) diagnosed with severe COPD), their age is ranged 65-75 years, they will be randomly divided into two groups; study group (A) 30 patients and study group (B) 30 patients. Study group (A): The patients in this group will receive the chest physiotherapy program for 20 min each day, for five days a week for 8 consecutive weeks. Study group (B): The patients in this group will receive the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, calf muscles, performed for 30 min /day for five days a week for 8 consecutive weeks. Femoral blood Flow, gluteus maximus, quadriceps and calf muscles strength and pulmonary function (FEV1/FVC) will be measured for both groups pre and post-treatment, then after 3 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control Group Chest physical therapyThe patients in this group were received the chest physiotherapy program for 20 min each day, for five days a week for8 consecutive weeks. |
| Study Group | Experimental | Other: Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) of gluteus max., quadriceps, and calf muscles performed for 30 min /day for five days a week for 8 consecutive weeks. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- A diagnosis of COPD with FEV1/FVC <50% predicted as per the GOLD guidelines.
- Self-reported dyspnea and/or arm fatigue during at least one activity of daily living that required arm exercise.
- Dyspnea and/or physical activity fatigue were self-reported by the Borg Scale.
- Before entering in the study, all patients had their pulmonary function optimized with long-acting bronchodilators and corticosteroids.
Key exclusion criteria (6 listed)
- • Patients with unstable angina pectoris.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)Also: Chest physical therapy plus NMESThe patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, and calf muscles performed for 30 min /day for five days a week for 8 consecutive weeks. | Other | Study Group |
| Control Group Chest physical therapyAlso: Chest physical therapyThe patients in this group were received the chest physiotherapy program for 20 min each day, for five days a week for 8 consecutive weeks | Other | Control Group |
Primary outcome
Six-minute walking test (Physical function assessment
Time frame: change from baseline to 8 weeks after intervention and 3 months as a follow-up
The six-minute walking distance (6MWD) was measured according to a standardized protocol. * Subjects were instructed to walk at their own pace along a 34.5-m corridor from one end to the other, covering as much ground as possible in the allotted time. * Subjects were allowed to stop and rest during the test, but they were instructed to resume walking as soon as they felt able to do
Pulmonary function test
Time frame: change from baseline to 8 weeks after intervention and 3 months as a follow-up
Pulmonary capacity and respiratory muscle functions will be assessed using the CPFS/D USB™ 187 Spirometer (Medical Graphics-MGC, St. Paul, MN, USA) with airflow being measured by a 188 calibrated Pitot tube (PreVent, Pneumotach). The participant completed at least three acceptable maximal forced and slow expiratory maneuvers after 15 min the inhalation of 400 mg of salbutamol 190 via a metered-dose inhaler. Forced vital capacity (FVC, L), forced expiratory volume in one second (FEV1, L), FEV1/ FVC, and inspiratory capacity (IC) will be measured according to American Thoracic Society standards
Muscle strength measurement
Time frame: change from baseline to 8 weeks after intervention and 3 months as a follow-up
To determine the maximal muscle strength the Lafayette manual muscle test system (USER MANUAL) (MMT) Model 01163, White Plains, New York (10602) of gluteus maximus, quadriceps and calf muscles will be measured on right lower limb.
1 secondary outcome
Blood flow velocimetry measurement
Time frame: change from baseline to 8 weeks after intervention and 3 months as a follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibrahim I. I Abu zaid, PhD study director
Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) in people with Pulmonary Rehabilitation and Chronic Obstructive Lung Disease, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walking test (Physical function assessment (time frame: change from baseline to 8 weeks after intervention and 3 months as a follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.