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

NCT06955000 | Not Yet Recruiting DMC

• 1 other identifier: restless leg syndrome and copd
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

DETERMINE HOW TO IMPROVE THE QUALITY OF LIFE FOR PATIENTS WITH COPD BY DECREASING TINTENSITY OF THE RESTLESS SYNDROME

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

restless leg syndrom,lazer puncture therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Hemoglobin Test:

  3 month

Study Arms (2)

aerobic training

EXPERIMENTAL

3 sessions per week,40 mints each session, mild to moderate intensity exercise

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.

Device: laser puncture therapy

Interventions

traidmail DEVICE

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

aerobic training

laser puncture therapy DEVICE

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

Also known as: laser puncture prob therapy

laser puncture therapy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Pharos University in Alexandria: lead

Study Sites (1)

Ola Mohamed Elsayed Elgohary

Alexandria, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at cardiovascular pulmonary and geratrics departement faculty of physical therapy pharos university

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: May 25, 2025
• Primary Completion: July 5, 2025
• Study Completion: July 25, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

EG (1)