Effect of Aquatic Exercises on Muscle Strength and Quality of Life in Children With Sickle Cell Anemia

NCT06939933 | Completed DMC

• 1 other identifier: KFSIRB200-462
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Sickle cell anemia is a global public health disorder that affects millions of people across the globe. It is an inherited autosomal recessive hemoglobin condition caused by a beta-globin gene mutation that results in an aberrant sickle cell hemoglobin molecule with glutamic acid replaced by valine at position six of the beta-globin chain. Sickle cell anemia is a hereditary illness characterized by persistent microvascular blockage by sickle-shaped cells, chronic hemolytic anemia, and tissue destruction. Red-cell dehydration, hypoxemia, metabolic acidosis, and hyperthermia are typical vaso-occlusive triggers. Children with sickle cell anemia frequently have poor growth and nutritional status, increased protein turnover, decreased lean body mass, and elevated resting and lower activity energy expenditures. These clinical findings present a problem for recommending exercise when taken as a whole, while engaging in physical activity increases the chance of issues like a "painful episode,". Children with sickle cell anemia miss out on the favorable health effects of regular physical activity, such as the growth of lean body mass, strength, and fitness. Vaso-occlusive events are recurring and prevalent in sickle cell anemia-related morbidity. Patients also have a higher chance of developing central nervous system conditions such cerebral vasculopathy and overt and covert stroke. It has been noted that the pathophysiological symptoms of SCA decrease skeletal muscle function. In fact, it has been demonstrated that individuals with SCA have diminished forearm and respiratory muscular maximal strength as well as peak locomotory muscle power. Vaso-occlusion, chronic hemolytic anemia, and vasculopathy form the core of sickle cell anemia pathophysiology and result in both acute and chronic consequences that have a significant negative influence on quality of life QoL. Even though clinical care for children with SCA has significantly improved in developed countries over the past few decades, children and adolescents with SCA still have a lower quality of life than their peers due to painful vaso-occlusive crises, frequent hospital admissions, and lengthy hospital stays. Generic and disease-specific measures of quality of life have been developed and validated in chronic illnesses to evaluate the influence of health on functional domains such physical and mental well-being, exhaustion, pain, social engagement, relationships, and emotional distress. Examples include the Child Health Questionnaire, Pediatric Quality of Life Sickle Cell Disease Module PedsQL SCD, and Patient-Reported Outcomes Measurement Information System PROMIS, all of which have been used to study SCA and have revealed various degrees of quality-of-life impairment, primarily in the United States. Health-related quality of life refers to the patient's assessment of how his or her well-being and level of functioning, in comparison to the perceived ideal, are influenced by personal health. A health-related quality of life assessment often considers physical, social, and emotional functioning in addition to academic and occupational performance. Studies on the quality of life for people with SCA have significantly risen during the previous five years. Measurement of health-related quality of life is beneficial for many reasons. Health-related quality of life can be used to measure the efficacy and effectiveness of treatment interventions, to predict outcomes and resource use, and to direct therapy. More importantly, the measurement of health-related quality of life aids in understanding the burden of disease that patients experience.

Conditions

Sickle Cell Anemia in Children

Keywords

aquatic exercises; sickle cell anemia; rehabilitation; quality of life; muscle power; children

Outcome Measures

Primary Outcomes (5)

• assessing hand grip strength

  Hand-held dynamometer for assessing hand grip strength

  3 months

• assess weight

  The Calibrated floor Health scale was used to assess weight

  3 months

• assessing Lower limb, trunk muscles strength.

  3- Lafayette dynamometer for assessing Lower limb and trunk muscles strength.

  3 months

• determine the child's standing height in centimeters (cm).

  The calibrated floor health scale was used to determine the child's standing height in centimeters (cm).

  3 months

• assessing Health related quality of life

  4- Pediatric quality of life inventory 3.0 generic for assessing Health related quality of life

  3 months

Study Arms (2)

group (A)

EXPERIMENTAL

aquatic exercised in addition to the designed physical

Other: aquatic exercise in addition to physical exercise

group (B)

EXPERIMENTAL

designed physical therapy program only

Genetic: designed physical exercises only

Interventions

aquatic exercise in addition to physical exercise OTHER

Aquatic exercise refers to the use of water that facilitates the application of established therapeutic interventions, including stretching, strengthening, joint mobilization, balance and gait training and endurance training. Water has been throughout history for a variety of purposes including ; physical therapy, rehabilitation and sport. There activities are made possible by water's special qualities and the influence of these attributes on humans. Hydrotherapy is one of the most popular forms of complementary therapies that help in the treatment of children with disabilities. It is known to provide an opportunity to the children to do easier exercise. It also improves . Physical therapy and tailored exercise programs can help improve muscle strength, endurance, and overall physical function in children with SCA. Such programs need to be carefully designed to avoid triggering pain crises while promoting physical health and improving quality of life.

group (A)

designed physical exercises only GENETIC

Physical therapy and tailored exercise programs can help improve muscle strength, endurance, and overall physical function in children with SCA. Such programs need to be carefully designed to avoid triggering pain crises while promoting physical health and improving quality of life (Ballas et al., 2010). benefit from anaerobic activity patterns (Dougherty et al., 2018). A study to examine maximal muscle strength and peak power in children with sickle cell anemia found that maximal muscle strength and peak power are significantly less in children with sickle cell anemia compared to the control group

group (B)

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The children are assigned aged from 6-10 years.
• Both genders were included.
• They were able to follow instructions and understand commands.
• Children were free from orthopedic deformities in the upper and lower limbs.
• Children were not practicing any kind of sports.
• Children must have a normal body mass index (BMI) in relation to their ages.

You may not qualify if:

• Children with neurological, musculoskeletal, and cardiopulmonary diseases limit their movement.
• Children with cognitive disorders.
• Children suffering from auditory impairment that limit him or her from answering the questions.
• Children with vaso occlusive crises.
• Children who have another disease associated with SCA.
• Children who had recent blood transfusion.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Eman samir shaltout

Tanta, Egypt

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: eman samir shaltout

Model Details: Intervention study model Parallel assignment The study will include 50 spastic children suffering from sickle cell anemia ( age 6 to 10 years and divided into 2 randomized subgroups. Group (A): Will receive aquatic exercised in addition to the designed physical Physical program : Group (B): Will receive the designed physical therapy program only.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 23, 2025
• Study Start: November 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

EG (1)