- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05519852
Pilates Physical Activity in Sickle Cell Disease
August 25, 2022 updated by: Ali Mohamed Ali ismail, Cairo University
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali Ismail, lecturer
- Email: allooka2012@gmail.com
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt
- Recruiting
- Faculty of Physical Therapy Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- sedentary sickle disease patients from both both sexes in medical stable condition
Exclusion Criteria:
- cardiac complaints, pregnant women, patients who smoke or drink alchols
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates group
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
|
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
|
|
No Intervention: control group
The patients will not receive training (20 patients)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Time Frame: It will be measured after 12 weeks
|
it assess sleep quality
|
It will be measured after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
six minutes walking distance
Time Frame: It will be measured after 12 weeks
|
it will assess physical capacity
|
It will be measured after 12 weeks
|
|
quadriceps strength
Time Frame: It will be measured after 12 weeks
|
it will assess the muscular strength of dominant quadriceps
|
It will be measured after 12 weeks
|
|
hand grip strength
Time Frame: It will be measured after 12 weeks
|
it will assess the muscular strength of dominant hand grip
|
It will be measured after 12 weeks
|
|
physical component summary of short-form-36 questionnaire
Time Frame: It will be measured after 12 weeks
|
it will assess physical health
|
It will be measured after 12 weeks
|
|
mental component summary of short-form-36 questionnaire
Time Frame: It will be measured after 12 weeks
|
it will assess mental health
|
It will be measured after 12 weeks
|
|
beck depression inventory
Time Frame: It will be measured after 12 weeks
|
it is a questionnaire assessing depression
|
It will be measured after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali Ismail, Lecturer, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2022
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
August 24, 2022
First Submitted That Met QC Criteria
August 25, 2022
First Posted (Actual)
August 29, 2022
Study Record Updates
Last Update Posted (Actual)
August 29, 2022
Last Update Submitted That Met QC Criteria
August 25, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003820
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.