AzTrials
AzTrials

SystemicNCT05321108

Aerobic Exercise Versus Whole-Body Vibration on Fatigue, Functional Capacity, Quality of Life in Systemic Lupus

A study testing Group A (GA)(Aerobic exercise group) and Group B (GB) (Whole-body vibration (WBV) group) in people with Systemic and Lupus, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 25 to 45 years, women only
Conditions the study is for
Systemic, Lupus
What is being tested?
Group A (GA)(Aerobic exercise group) and Group B (GB) (Whole-body vibration (WBV) group)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteEgypt
Study dates
1 Mar 2022to Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • Have a depressive disorder.
  • Undergo total hip replacement.
  • Diabetes, cancer.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Physical Therapy. Cairo University

    Giza, 11432

Other trials in Egypt

About this study

Official title: Aerobic Exercise Versus Whole-Body Vibration On Fatigue, Functional Capacity And Quality Of Life In Patients With Systemic Lupus Erythematosus: A Randomized Controlled Trial

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?

Read the detailed description

Procedures of the study:

The assessment procedures

  1. Measuring of functional capacity and health-related quality of life in Systemic Lupus Erythematosus patients by: The Systemic Lupus Erythematosus Quality of Life (SLEQOL) questionnaire SLEQoL is a 40-item questionnaire that was developed and validated in an English-speaking cohort of SLE patients in Singapore 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. Arabic version of the SLEQOL The questionnaire which is a reliable and valid specific instrument for measuring the quality of life of Egyptian SLE patients, cross-cultural adaptation and validation of SLEQoL has been performed in Arabic (Egypt). 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. The Arabic version of the SLEQOL is used to measure health-related quality of life in Systemic Lupus Erythematosus patients pre-treatment (pre-test) and after 6 weeks (post-treatment 1) and after 12 weeks of the study (post-treatment 2).
  2. Measuring of functional capacity in Systemic Lupus Erythematosus patients by: Health Assessment Questionnaire(HAQ) HAQ has been reported as the best tool targeting functional disability. Moreover, the validity and reliability of the HAQ have been confirmed in several ethnic groups. It contains 20 questions grouped into eight subscales (dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities). 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). The highest score for any question determines the score for the subscale in question. The use of any assistive device or any other person's help was given a score of 2. The HAQ disability index was calculated as the sum of the scores for various subscales, divided by the number of subscales responded to, and results in a score between 0 and 3. The Arabic- Health Assessment Questionnaire(HAQ) The Arabic HAQ is a reliable and valid instrument that can be self-administered to Arabic patients to evaluate their functional disability. The Arabic HAQ is used to measure functional capacity in Systemic Lupus Erythematosus patients pre-treatment (pre-test) and after 6 weeks (post-treatment 1) and after 12 weeks of the study (post-treatment 2).
  3. Measuring of fatigue in Systemic Lupus Erythematosus patients by:

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). The FSS can be scored either by obtaining a total score or by calculating a mean score across all 9 items, with higher scores indicating more severe fatigue. The most appropriate tool to measure fatigue in SLE. The FSS is widely used in clinical practice and research and has been translated into several languages.

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.

The Arabic version of the FSS-Arabic (FSS-Ar) is used to measure fatigue in Systemic Lupus Erythematosus patients pre-treatment (pre-test) and after 6 weeks (post-treatment 1) and after 12 weeks of the study (post-treatment 2).

Therapeutic procedures:

This current study will be designed to determine which is more effective aerobic exercise or whole-body vibration on fatigue, functional capacity and quality of life in patients with systemic lupus erythematosus so the treatment protocol will be applied through the following steps and phases:

Therapeutic intervention for the study will be started at the same time for all groups of the study as follows;

  1. Aerobic exercise Exercise Program:
  • The program will consist of three 50-minute exercise sessions weekly over 12 weeks.
  • Each exercise session included graded treadmill machine walking and stepping exercises. Maximal exercise tolerance test (Bruce protocol) will be performed on the preceding day of the exercise program. Maximum heart rate is calculated by the formula (220 -age).
  • The graded treadmill machine walking exercise will be started with a 5-minute warm-up period with the intensity of about 40% of maximum heart rate followed by a 30-minutes training phase. The training intensity will be arranged at about 70-85% of maximum heart rate and ended with a 5-minute cool-down period with the intensity of about 40% of maximum heart rate. Exercising sessions will be comprised of warming up (stretching, turning joints, and walking slowly), the main program (treadmill machine walking), and cooling down (stretching, turning joints, and walking slowly).
  • 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.
  1. Whole-body vibration (WBV)
  • Whole-body vibration apparatus (model power plate-my5tm, made in the United States) with frequency 30-40Hz and 2 mm of amplitude will be used for whole-body vibration program by reciprocating vertical displacements on the left and right side of a fulcrum.
  • The subjects will stand on a whole-body vibrator and they will be vibrated in a squat positioning.
  • The subjects will exercise for 16 minutes (1 min vibration with 8 iterations and 1 min break between each iteration), 20, and 24 minutes in the first week to the third week, the fourth week to the sixth week, and the seventh week to the eighth week respectively and also to the end of the study after 12 weeks.
  • The WBV group performed a training program 3 times a week with at least one day between each session for 12 weeks.

Treatment procedure Interventions

Participants were randomly assigned to:

  • Group A (GA) (Aerobic exercise group): Will receive aerobic exercise: (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.
  • Group B (GB) (Whole-body vibration (WBV) group): 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.
Conditions
Systemic, Lupus
Being tested
Group A (GA)(Aerobic exercise group), Group B (GB) (Whole-body vibration (WBV) group)
Keywords
Aerobic, Exercise, Systemic, Lupus, Whole, Body, Vibration
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)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.

Study groups in NCT05321108
Study groupRoleWhat they receive
Group A (GA) (Aerobic exercise group):Experimentalthe 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.
Receives: Other: Group B (GB) (Whole-body vibration (WBV) group)
Group B (GB) (Whole-body vibration (WBV) group)Experimentalthe 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.
Receives: Other: Group A (GA)(Aerobic exercise group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2 hours

  2. 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

    Measured: 2 hours

  3. 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.

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start1 Mar 2022
  3. Primary completionNov 2023 (estimated)
  4. Study completionFeb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321108
Sponsor's protocol ID
P.T.REC/012/003502
Status last verified
Aug 2023
First submitted
6 Mar 2022
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group A (GA)(Aerobic exercise group) and Group B (GB) (Whole-body vibration (WBV) group) in people with Systemic and Lupus, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Assessment Questionnaire(HAQ) (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in