Back to resultsPilates Physical Activity in Sickle Cell Disease
Primary Purpose
Sickle Cell Disease
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pilates training
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease
Eligibility Criteria
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
Sites / Locations
- Faculty of Physical Therapy Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pilates group
control group
Arm Description
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 patients will not receive training (20 patients)
Outcomes
Primary Outcome Measures
Pittsburgh Sleep Quality Index
it assess sleep quality
Secondary Outcome Measures
six minutes walking distance
it will assess physical capacity
quadriceps strength
it will assess the muscular strength of dominant quadriceps
hand grip strength
it will assess the muscular strength of dominant hand grip
physical component summary of short-form-36 questionnaire
it will assess physical health
mental component summary of short-form-36 questionnaire
it will assess mental health
beck depression inventory
it is a questionnaire assessing depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05519852
Brief Title
Pilates Physical Activity in Sickle Cell Disease
Official Title
Quality of Life Response to Pilates Physical Activity in Sickle Cell Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilates group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
No Intervention
Arm Description
The patients will not receive training (20 patients)
Intervention Type
Behavioral
Intervention Name(s)
Pilates training
Intervention Description
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
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
it assess sleep quality
Time Frame
It will be measured after 12 weeks
Secondary Outcome Measure Information:
Title
six minutes walking distance
Description
it will assess physical capacity
Time Frame
It will be measured after 12 weeks
Title
quadriceps strength
Description
it will assess the muscular strength of dominant quadriceps
Time Frame
It will be measured after 12 weeks
Title
hand grip strength
Description
it will assess the muscular strength of dominant hand grip
Time Frame
It will be measured after 12 weeks
Title
physical component summary of short-form-36 questionnaire
Description
it will assess physical health
Time Frame
It will be measured after 12 weeks
Title
mental component summary of short-form-36 questionnaire
Description
it will assess mental health
Time Frame
It will be measured after 12 weeks
Title
beck depression inventory
Description
it is a questionnaire assessing depression
Time Frame
It will be measured after 12 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, Lecturer
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail
Organizational Affiliation
Lecturer, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Pilates Physical Activity in Sickle Cell Disease
We'll reach out to this number within 24 hrs