Laser Puncture and Program of Lifestyle Modification in Lupus Females

NCT ID: NCT05381545

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

laser puncture, energy expenditure programming, and low-calories recommended diet programming

Intervention Type BEHAVIORAL

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.

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 ).

Group Type ACTIVE_COMPARATOR

energy expenditure programming and low-calories recommended diet programming

Intervention Type BEHAVIORAL

This research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week) combined with low calorie diet.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* obese female participants
* Lupus females

Exclusion Criteria

* pregnant lupus female
* lactating lupus females
* neurologic or articular disorders
* another autoimmune conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Ismail, lecturer

Role: CONTACT

02 01005154209

Facility Contacts

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Ali Ismail, lecturer

Role: primary

02 01005154209

Other Identifiers

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P.T.REC/012/003660

Identifier Type: -

Identifier Source: org_study_id

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