NCT05321108

Brief Summary

PURPOSE: … The aim of this study will be conducted to investigate the therapeutic efficacy of Aerobic exercise versus whole-body vibration on fatigue, functional capacity and quality of life in patients with systemic lupus erythematosus RESEARCH QUESTION: The problem of the study will be designed in a questioner form " which is more effective Aerobic Exercise or Whole-Body Vibration on Fatigue, Functional Capacity And Quality Of Life In Patients With Systemic Lupus Erythematosus?

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
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

March 6, 2022

Last Update Submit

August 30, 2023

Conditions

SystemicLupus

Keywords

AerobicExerciseSystemicLupusWholeBodyVibration

Outcome Measures

Primary Outcomes (3)

  • Health Assessment Questionnaire(HAQ)

    Health Assessment Questionnaire (HAQ)It contains 20 questions grouped into eight subscales The response categories are "without any difficulty" (score = 0),"with some difficulty" (score = 1), "with much difficulty" (score = 2), and "unable to do" (score = 3).

    2 hours

  • Measuring of fatigue in Systemic Lupus Erythematosus patients by: Fatigue severity scale

    Fatigue severity scale The Fatigue severity scale (FSS) is a self-reported questionnaire It consists of 9 statements that rate the severity of the patient's fatigue symptoms in terms of how these symptoms affect motivation, exercise, physical function, and activities of daily living. Reflecting on their condition, patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement). Arabic version of the FSS-Arabic (FSS-Ar) The development of an Arabic version of the FSS-Arabic (FSS-Ar) and its validation would be of great value, as it would allow clinicians and researchers to investigate the incidence and impact of fatigue associated with it

    2 hours

  • functional capacity and health-related quality of life The Systemic Lupus Erythematosus Quality of Life (SLEQOL) questionnaire

    SLEQoL is a 40-item questionnaire and it assesses the quality of life of Systemic Lupus Erythematosus (SLE) patients across six domains including physical functioning, occupational activities, symptoms, treatment, mood and self-image. Each domain score varies from 1 to 7, with higher scores indicating poorer quality of life. The total scores of the questionnaire vary between 40 and 280.

    2 hours

Study Arms (2)

Group A (GA) (Aerobic exercise group):

EXPERIMENTAL

the patient will receive aerobic exercise program: (graded treadmill machine walking and stepping exercises). The second part of the exercise program will be 10 minutes of stepping exercise at a speed of 96 beats per minute using a 20-cm-high bench, with rest after the first 5 minutes. Three sessions per week for 12 weeks.

Other: Group B (GB) (Whole-body vibration (WBV) group)

Group B (GB) (Whole-body vibration (WBV) group)

EXPERIMENTAL

the patient will receive whole-body vibration with frequency 30-40Hz and 2 mm of amplitude will be used for the whole-body vibration program by reciprocating vertical displacements on the left and right side of a fulcrum. The WBV group performed a training program 3 times a week with at least one day between each session for 12 weeks.

Other: Group A (GA)(Aerobic exercise group)

Interventions

Group A (GA)(Aerobic exercise group)OTHER

Aerobic Exercise has been demonstrated to be a safe strategy to improve several health outcomes in Systemic lupus erythematosus (SLE)SLE, including depressive symptoms or, even more importantly, fatigue and quality of life.

Group B (GB) (Whole-body vibration (WBV) group)
Group B (GB) (Whole-body vibration (WBV) group)OTHER

(WBV) has been growing over the years. WBVE occurs when the subject is in contact with the vibrating platform in operation and is exposed to the generated mechanical vibrations. WBV has a positive action on muscle strength, bone formation, balance, flexibility, functional capacity and fatigue.

Group A (GA) (Aerobic exercise group):

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Criteria for selecting the patients include the following:
  • This study turned will be done on 68 patients.
  • Age range between 25-45 years.
  • Female patients with a diagnosis of Systemic Lupus Erythematosus (SLE).
  • A follow-up of 12 months.
  • Clinical and treatment stability during the 6 previous months.
  • Not performing regular exercise.
  • All patients enrolled in the study will have their informed consent

You may not qualify if:

  • The subjects are excluded from the study if they will meet one of the following criteria;
  • Have had biological treatment in the previous 6 months.
  • A background of clinical cardiovascular disease in the previous year.
  • Present contraindications to performing the exercise.
  • Other associated rheumatic diseases, pregnancy, active acute or chronic infection.
  • Acute renal failure, cardiac or pulmonary involvement.
  • Have a depressive disorder.
  • Undergo total hip replacement.
  • Diabetes, cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy. Cairo University

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Ereny S. Wahba khalil, Asst.Prof.Dr

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Procedures of the study: The assessment procedures 1\. Measuring of functional capacity and health-related quality of life in Systemic Lupus by: The Systemic Lupus Erythematosus Quality of Life (SLEQOL) questionnaire (Arabic version of the SLEQOL) 2- Measuring of functional capacity in Systemic Lupus by: Health Assessment Questionnaire (HAQ) The Arabic- Health Assessment Questionnaire (HAQ) 3- Measuring of fatigue in Systemic Lupus by: Fatigue severity scale (Arabic version of the FSS-Arabic) (FSS-Ar): Therapeutic procedures: 1. Aerobic exercise 2. Whole-body vibration (WBV)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of physical therapy for surgery - Faculty of physical therapy, Cairo University

Study Record Dates

First Submitted

March 6, 2022

First Posted

April 11, 2022

Study Start

March 1, 2022

Primary Completion

November 1, 2023

Study Completion

February 1, 2024

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)