Efficacy of Interval Aerobic Training Versus Laser Puncture Therapy on Restless Leg Syndrome in Copd Patient

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: traidmail; Device: laser puncture therapy

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Ola Mohamed Elsayed Elgohary
    • Contact: ola elgohary, lecturer; Phone Number: 01227191398; Email: ola.elgohary@pua.edu.eg
    • Contact: ola elgohary, lecturer; Phone Number: 0122719398; Email: ola.elgohary@pua.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerobic training; 3 sessions per week,40 mints each session, mild to moderate intensity exercise	Device: traidmail; 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
Experimental: laser puncture therapy; 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.	Device: laser puncture 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; Other Names: laser puncture prob therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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,	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin Test:	Red blood cells contain hemoglobin, a protein that is rich in iron. It transports oxygen throughout the body from the lungs.	3 month

Collaborators and Investigators

• Sponsor: Pharos University in Alexandria

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2025
• Primary Completion (Estimated): July 5, 2025
• Study Completion (Estimated): July 25, 2025

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: restless leg syndrom,lazer puncture therapy
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Behavioral Symptoms; Respiratory Tract Diseases; Neurobehavioral Manifestations; Lung Diseases; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Dyskinesias; Psychomotor Disorders; Parasomnias; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Psychomotor Agitation; Restless Legs Syndrome
• Other Study ID Numbers: restless leg syndrome and copd

Plan for Individual participant data (IPD)

Study Data/Documents

1. Study Protocol
   Information comments:

   Döner A, Taşci S, Bilgin A. The Effect of Massage, Acupressure and Reflexology on Restless Legs Syndrome Severity and Sleep Quality in Patients Receiving Haemodialysis Treatment: A Systematic Review and Meta-Analysis. Nursing Open. 2025 Feb;12(2):e70135.

   26-Mitchell UH, Johnson AW, Myrer B. Comparison of two infrared devices in their effectiveness in reducing symptoms associated with RLS. Physiotherapy theory and practice. 2011 Jun 1;27(5):352-9.

   27-Tang L, Zhao N, Gao X, Li J, Yu X, Liang R, Xie C, Li L, Wang Q, Yang W. Acupuncture treatment of restless legs syndrome: a randomized clinical controlled study protocol based on PET-CT and fMRI. Frontiers in Psychiatry. 2024 Dec 24; 15:1481167.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No