Sickle Cell DiseaseNCT05519852
Pilates Physical Activity in Sickle Cell Disease
A study testing Pilates training in people with Sickle Cell Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Sickle cell anemia (SCA) is a life-threatening hereditary hemoglobinopathy characterized by hemoglobin (Hb) polymerization that affects many people worldwide.Reduced physical capacity is common in people with SCA. Pilates is a form of physical activity that recently used in clinicial practice Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Pilates training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2022to 30 Dec 2022
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- sedentary sickle disease patients from both both sexes in medical stable condition
Who cannot join
- cardiac complaints, pregnant women, patients who smoke or drink alchols
Trial locations and contacts
1 site in 1 country.
Ali Ismail, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza, Dokki
Ali Ismail, lecturer, 02 01005154209, allooka2012@gmail.com
About this study
Official title: Quality of Life Response to Pilates Physical Activity in Sickle Cell Disease
Sickle cell anemia (SCA) is a life-threatening hereditary hemoglobinopathy characterized by hemoglobin (Hb) polymerization that affects many people worldwide.Reduced physical capacity is common in people with SCA. Pilates is a form of physical activity that recently used in clinicial practice
Read the detailed description
SCA patients (40 patients) with ages more than 18 years will join randomly the pilates group (20 patients) or control non exercised group (20 patients). Pilates will be trained 30 minutes (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months
- Conditions
- Sickle Cell Disease
- Being tested
- Pilates training
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates trainingBehavioural
the pilates group (20 patients) will be trained 30 minutes of pilates exercise (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Pilates group | Experimental | this pilates group (20 patients) will be trained 30 minutes of pilates (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months Receives: Behavioral: Pilates training |
| control group | No intervention | The patients will not receive training (20 patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
it assess sleep quality
Measured: It will be measured after 12 weeks
Secondary outcomes (6)
six minutes walking distance
it will assess physical capacity
Measured: It will be measured after 12 weeks
quadriceps strength
it will assess the muscular strength of dominant quadriceps
Measured: It will be measured after 12 weeks
hand grip strength
it will assess the muscular strength of dominant hand grip
Measured: It will be measured after 12 weeks
physical component summary of short-form-36 questionnaire
it will assess physical health
Measured: It will be measured after 12 weeks
mental component summary of short-form-36 questionnaire
it will assess mental health
Measured: It will be measured after 12 weeks
beck depression inventory
it is a questionnaire assessing depression
Measured: It will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start22 Jun 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, Principal investigator, Lecturer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519852
- Sponsor's protocol ID
- P.T.REC/012/003820
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Response to Pilates Physical Activity in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05519852
- Acronym / sponsor ID
- P.T.REC/012/003820
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sickle cell anemia (SCA) is a life-threatening hereditary hemoglobinopathy characterized by hemoglobin (Hb) polymerization that affects many people worldwide.Reduced physical capacity is common in people with SCA. Pilates is a form of physical activity that recently used in clinicial practice
Detailed description
SCA patients (40 patients) with ages more than 18 years will join randomly the pilates group (20 patients) or control non exercised group (20 patients). Pilates will be trained 30 minutes (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates group | Experimental | Behavioral: Pilates trainingthis pilates group (20 patients) will be trained 30 minutes of pilates (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months |
| control group | No intervention | –The patients will not receive training (20 patients) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- sedentary sickle disease patients from both both sexes in medical stable condition
Key exclusion criteria (1 listed)
- cardiac complaints, pregnant women, patients who smoke or drink alchols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates trainingthe pilates group (20 patients) will be trained 30 minutes of pilates exercise (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months | Behavioural | Pilates group |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: It will be measured after 12 weeks
it assess sleep quality
6 secondary outcomes
six minutes walking distance
Time frame: It will be measured after 12 weeks
quadriceps strength
Time frame: It will be measured after 12 weeks
hand grip strength
Time frame: It will be measured after 12 weeks
physical component summary of short-form-36 questionnaire
Time frame: It will be measured after 12 weeks
mental component summary of short-form-36 questionnaire
Time frame: It will be measured after 12 weeks
beck depression inventory
Time frame: It will be measured after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Ismail, Lecturer contact
Ali Ismail principal investigator
Lecturer, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates training in people with Sickle Cell Disease, 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 1 inclusion and 1 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 29 Aug 2022. 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?
Contact Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: It will be measured after 12 weeks). 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 29 Aug 2022.