Chronic Obstructive Pulmonary DiseaseNCT06955000
Efficacy of Interval Aerobic Training Versus Laser Puncture Therapy on Restless Leg Syndrome in Copd Patient
A study testing traidmail and laser puncture therapy in people with Chronic Obstructive Pulmonary Disease, run by Pharos University in Alexandria at 1 site in Egypt.
Trial summary
DETERMINE HOW TO IMPROVE THE QUALITY OF LIFE FOR PATIENTS WITH COPD BY DECREASING TINTENSITY OF THE RESTLESS SYNDROME Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- traidmail and laser puncture therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2025to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men with COPD who were between the ages of 40 and 60 and had a BMI between 25.5 and 29.0 were eligible to enroll if they had received a diagnosis of COPD at least two years priorAn intense desire to move the legs is frequently accompanied by unpleasant and uncomfortable leg sensations. Patients usually experience worsening symptoms when they are at rest, sitting, or lying down. Walking and stretching are examples of physical activity that can help reduce these symptoms to some or all of their intensity
Who cannot join
- 1) Individuals suffering from acute infections and malignant diseases; 2) Individuals with a history of kidney disease, hiatus hernia, severe gastro-esophageal reflux, and osteoporosis 3) Patients with severe anemia and congestive heart failure 4) Individuals with severe neurological and musculoskeletal conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ola Mohamed Elsayed Elgohary
Alexandria
ola elgohary, lecturer, 01227191398, ola.elgohary@pua.edu.eg
ola elgohary, lecturer, 0122719398, ola.elgohary@pua.edu.eg
About this study
Official title: Efficacy of Interval Aerobic Training Versus Laser Puncture Therapy on the Severity of Restless Leg Syndrome in Chronic Obstructive Lung Disease Patients
DETERMINE HOW TO IMPROVE THE QUALITY OF LIFE FOR PATIENTS WITH COPD BY DECREASING TINTENSITY OF THE RESTLESS SYNDROME
Read the detailed description
Patients with restless legs syndrome can benefit greatly from aerobic exercise, and a novel treatment for enhancing quality of life is laser puncture therapy.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- traidmail, laser puncture therapy
- Keywords
- restless leg syndrom,lazer puncture 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.
traidmailDevice
Patients in this group were instructed to sit on a stationary bicycle ergometer. The patients will be given explained the aerobic interval exercise training program and the intensity will be assessed using a modified Borg scale
laser puncture therapyDevice
Also called laser puncture prob therapy
This group's patients were all exposed to LLLT utilising Phyaction CL Phyaction, Bilzen, Belgium, which had the following specs: frequency 500 Hz, output 5-20 MW, wavelength 905 nm. For five minutes, a laser probe was applied to acupuncture sites
| Study group | Role | What they receive |
|---|---|---|
| aerobic training | Experimental | 3 sessions per week,40 mints each session, mild to moderate intensity exercise Receives: Device: traidmail |
| laser puncture therapy | Experimental | There were three sessions per week, each lasting 40 minutes. Five minutes later, a laser probe was applied to the acupuncture sites on the leg. Receives: Device: laser puncture therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restless Legs Syndrome Rating Scale (IRLS):
Developed as a tool for assessing the severity Restless Legs Syndrome (RLS), the 10-item questionnaire asks respondents to use Likert-type ratings to indicate how acutely the disorder has affected them over the course of the past week. Questions can be divided into one of two catego- ries: disorder symptoms (nature, intensity, and frequency) and their impact (sleep issues, distur- bances in daily functioning, and resultant changes in mood)
Measured: 3 month
Fatigue severity scale (FSS):
The FSS is a short questionnaire that requires you to rate your level of fatigue. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you
Measured: 3 month
Six mint walk test:
the 6-minute walk test (6MWT) is a key study providing a functional, therapeutic response, and prognostic data that is valuable in the care of patients with respiratory as well as cardiac diseases. It is used widely due to its simplicity and reproducibility,
Measured: 3 month
Secondary outcomes (1)
Hemoglobin Test:
Red blood cells contain hemoglobin, a protein that is rich in iron. It transports oxygen throughout the body from the lungs.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start25 May 2025 (estimated)
- Primary completion5 Jul 2025 (estimated)
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Elsayed Elgohary, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955000
- Sponsor's protocol ID
- restless leg syndrome and copd
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Interval Aerobic Training Versus Laser Puncture Therapy on the Severity of Restless Leg Syndrome in Chronic Obstructive Lung Disease Patients
- ClinicalTrials.gov ID
- NCT06955000
- Acronym / sponsor ID
- restless leg syndrome and copd
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- restless leg syndrom,lazer puncture therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 25 Jul 2025 (estimated)
- First posted
- 2 May 2025 (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.
DETERMINE HOW TO IMPROVE THE QUALITY OF LIFE FOR PATIENTS WITH COPD BY DECREASING TINTENSITY OF THE RESTLESS SYNDROME
Detailed description
Patients with restless legs syndrome can benefit greatly from aerobic exercise, and a novel treatment for enhancing quality of life is laser puncture therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic training | Experimental | Device: traidmail3 sessions per week,40 mints each session, mild to moderate intensity exercise |
| laser puncture therapy | Experimental | Device: laser puncture therapyThere were three sessions per week, each lasting 40 minutes. Five minutes later, a laser probe was applied to the acupuncture sites on the leg. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men with COPD who were between the ages of 40 and 60 and had a BMI between 25.5 and 29.0 were eligible to enroll if they had received a diagnosis of COPD at least two years priorAn intense desire to move the legs is frequently accompanied by unpleasant and uncomfortable leg sensations. Patients usually experience worsening symptoms when they are at rest, sitting, or lying down. Walking and stretching are examples of physical activity that can help reduce these symptoms to some or all of their intensity
Key exclusion criteria (1 listed)
- 1) Individuals suffering from acute infections and malignant diseases; 2) Individuals with a history of kidney disease, hiatus hernia, severe gastro-esophageal reflux, and osteoporosis 3) Patients with severe anemia and congestive heart failure 4) Individuals with severe neurological and musculoskeletal conditions.
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 |
|---|---|---|
| traidmailPatients in this group were instructed to sit on a stationary bicycle ergometer. The patients will be given explained the aerobic interval exercise training program and the intensity will be assessed using a modified Borg scale | Device | aerobic training |
| laser puncture therapyAlso: laser puncture prob therapyThis group's patients were all exposed to LLLT utilising Phyaction CL Phyaction, Bilzen, Belgium, which had the following specs: frequency 500 Hz, output 5-20 MW, wavelength 905 nm. For five minutes, a laser probe was applied to acupuncture sites | Device | laser puncture therapy |
Primary outcome
Restless Legs Syndrome Rating Scale (IRLS):
Time frame: 3 month
Developed as a tool for assessing the severity Restless Legs Syndrome (RLS), the 10-item questionnaire asks respondents to use Likert-type ratings to indicate how acutely the disorder has affected them over the course of the past week. Questions can be divided into one of two catego- ries: disorder symptoms (nature, intensity, and frequency) and their impact (sleep issues, distur- bances in daily functioning, and resultant changes in mood)
Fatigue severity scale (FSS):
Time frame: 3 month
The FSS is a short questionnaire that requires you to rate your level of fatigue. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you
Six mint walk test:
Time frame: 3 month
the 6-minute walk test (6MWT) is a key study providing a functional, therapeutic response, and prognostic data that is valuable in the care of patients with respiratory as well as cardiac diseases. It is used widely due to its simplicity and reproducibility,
1 secondary outcome
Hemoglobin Test:
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traidmail and laser puncture therapy in people with Chronic Obstructive Pulmonary Disease, run by Pharos University in Alexandria 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restless Legs Syndrome Rating Scale (IRLS): (time frame: 3 month). 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 2 May 2025.