NCT05519852

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

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 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

June 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 24, 2022

Last Update Submit

August 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh Sleep Quality Index

    it assess sleep quality

    It will be measured after 12 weeks

Secondary Outcomes (6)

  • six minutes walking distance

    It will be measured after 12 weeks

  • quadriceps strength

    It will be measured after 12 weeks

  • hand grip strength

    It will be measured after 12 weeks

  • physical component summary of short-form-36 questionnaire

    It will be measured after 12 weeks

  • mental component summary of short-form-36 questionnaire

    It will be measured after 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

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

Behavioral: Pilates training

control group

NO INTERVENTION

The patients will not receive training (20 patients)

Interventions

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

Pilates group

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sedentary sickle disease patients from both both sexes in medical stable condition

You may not qualify if:

  • cardiac complaints, pregnant women, patients who smoke or drink alchols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Ali Ismail

    Lecturer, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

Ali Ismail, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 29, 2022

Study Start

June 22, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations