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

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06955000
• Lead Sponsor: Pharos University in Alexandria

Brief Summary

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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-02
• Study Start: 2025-05-25
• Primary Completion: 2025-07-05
• Study Completion: 2025-07-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Restless Legs Syndrome Rating Scale (IRLS):	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):	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:	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,

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ola Mohamed Elsayed Elgohary; 🇪🇬 Alexandria, Egypt