NCT05748899

Brief Summary

stress vulnerability is very common in lupus patients, specifically women, hence the rates of depression , insomnia, easy fatigue perception, anxiety are high in those women. pranayama is a yogic intervention that may treat the above problems

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

December 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 19, 2023

Last Update Submit

February 19, 2023

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • serum cortisol

    it will be taken from women at morning

    it will be measured after 6 weeks

Secondary Outcomes (9)

  • systolic blood pressure

    it will be measured after 6 weeks

  • diastolic blood pressure

    it will be measured after 6 weeks

  • pulse rate

    it will be measured after 6 weeks

  • respiratory rate

    it will be measured after 6 weeks

  • Pittsburgh Sleep Quality Index

    it will be measured after 6 weeks

  • +4 more secondary outcomes

Study Arms (2)

group number 1

EXPERIMENTAL

Group number 1 will receive home-based daily ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised).

Behavioral: Ujjayi pranayama

group number 2

NO INTERVENTION

The group number 2 will not receive pranayama training, so it serves as control lupus group

Interventions

Ujjayi pranayamaBEHAVIORAL

this group will receive home-based daily ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised).

group number 1

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • lupus women

You may not qualify if:

  • lupus co-morbidities
  • illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • ahmed elfahl

    Badr University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mariam El Ebrashy, lecturer

CONTACT

02 01001716570.Mariam.elabrashi@buc.edu.eg

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 Internal Medicine and Geriatrics

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 1, 2023

Study Start

December 15, 2022

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

EG(1)