NCT05381545

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

May 12, 2022

Last Update Submit

May 16, 2022

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • triglycerides

    a lipid component will be measured in blood of females

    12 weeks

Secondary Outcomes (3)

  • high density lipoprotein

    12 weeks

  • cholesterol

    12 weeks

  • low density lipoprotein

    12 weeks

Study Arms (2)

group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

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

Interventions

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

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 A
energy expenditure programming and low-calories recommended diet programmingBEHAVIORAL

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

Group B

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • obese female participants
  • Lupus females

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 19, 2022

Study Start

February 28, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

EG(1)