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Laser Puncture and Program of Lifestyle Modification in Lupus Females

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser puncture, energy expenditure programming, and low-calories recommended diet programming
energy expenditure programming and low-calories recommended diet programming
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • obese female participants
  • Lupus females

Exclusion Criteria:

  • pregnant lupus female
  • lactating lupus females
  • neurologic or articular disorders
  • another autoimmune conditions

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A

Group B

Arm Description

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.

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 ).

Outcomes

Primary Outcome Measures

triglycerides
a lipid component will be measured in blood of females

Secondary Outcome Measures

high density lipoprotein
a lipid component will be measured in blood of females
cholesterol
a lipid component will be measured in blood of females
low density lipoprotein
a lipid component will be measured in blood of females

Full Information

First Posted
May 12, 2022
Last Updated
May 16, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05381545
Brief Title
Laser Puncture and Program of Lifestyle Modification in Lupus Females
Official Title
Laser Puncture and Program of Lifestyle Modification in Lupus Females: Lipid Profile Response
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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 ).
Intervention Type
Behavioral
Intervention Name(s)
laser puncture, energy expenditure programming, and low-calories recommended diet programming
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
energy expenditure programming and low-calories recommended diet programming
Intervention Description
This research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week) combined with low calorie diet.
Primary Outcome Measure Information:
Title
triglycerides
Description
a lipid component will be measured in blood of females
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
high density lipoprotein
Description
a lipid component will be measured in blood of females
Time Frame
12 weeks
Title
cholesterol
Description
a lipid component will be measured in blood of females
Time Frame
12 weeks
Title
low density lipoprotein
Description
a lipid component will be measured in blood of females
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: obese female participants Lupus females Exclusion Criteria: pregnant lupus female lactating lupus females neurologic or articular disorders another autoimmune conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Laser Puncture and Program of Lifestyle Modification in Lupus Females

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