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NCT Number: NCT06955000

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

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

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Key information

Conditions

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

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Patients with restless legs syndrome can benefit greatly from aerobic exercise, and a novel treatment for enhancing quality of life is laser puncture therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Other names: laser puncture prob therapy

Primary outcomes

  1. 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)

  2. 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

  3. 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,

Secondary outcomes

  1. Hemoglobin Test:

    Time frame: 3 month

    Red blood cells contain hemoglobin, a protein that is rich in iron. It transports oxygen throughout the body from the lungs.

Sponsors and collaborators

Lead sponsor

Pharos University in Alexandria

Other

Registry information

Official study title

Efficacy of Interval Aerobic Training Versus Laser Puncture Therapy on the Severity of Restless Leg Syndrome in Chronic Obstructive Lung Disease Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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