Laser Puncture and Program of Lifestyle Modification in Lupus Females

Laser Puncture and Program of Lifestyle Modification in Lupus Females: Lipid Profile Response

Serum lipid profile was significantly dysregulated in female systemic lupus erythematosus (SLE) patients

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Behavioral: laser puncture, energy expenditure programming, and low-calories recommended diet programming; Behavioral: energy expenditure programming and low-calories recommended diet programming

Detailed Description

the research will recruit 64 female systemic lupus erythematosus (SLE) obese patients to divide them to two study groups equally. the study groups will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet for).One group only will receive an additional laser puncture (with 3-time per-week design). The following points will be directly contacted by laser, for two minutes: GB34&28, ST25&36&40, SP6, and CV4&9&12.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt
      • Recruiting
      • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• obese female participants
• Lupus females

Exclusion Criteria:

• pregnant lupus female
• lactating lupus females
• neurologic or articular disorders
• another autoimmune 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: group A; This 32-patient research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet for).This research group will receive an additional laser puncture (with 3-time per-week design). The following points will be directly contacted by laser, for two minutes: GB34&28, ST25&36&40, SP6, and CV4&9&12.	Behavioral: laser puncture, energy expenditure programming, and low-calories recommended diet programming; This research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week) combined with low calorie diet .This research group will receive an additional laser puncture (with 3-time per-week design). The following points will be directly contacted by laser, for two minutes: GB34&28, ST25&36&40, SP6, and CV4&9&12.
Active Comparator: Group B; This 32-patient research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet ).	Behavioral: energy expenditure programming and low-calories recommended diet programming; This research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week) combined with low calorie diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
triglycerides	a lipid component will be measured in blood of females	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high density lipoprotein	a lipid component will be measured in blood of females	12 weeks
cholesterol	a lipid component will be measured in blood of females	12 weeks
low density lipoprotein	a lipid component will be measured in blood of females	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: P.T.REC/012/003660

Drug and device information, study documents

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