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Effect of Exercise in Pediatric Hemophilia

H

Hasan Kalyoncu University

Status

Unknown

Conditions

Hemophilia A, Severe
Hemophilia Arthropathy

Treatments

Other: Specific exercise training
Other: Traditional exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT04754997
2020/116

Details and patient eligibility

About

This study investigates the effect of exercise training on pain, physical activity and quality of life in pediatric hemophilia patients.

Full description

Hemophilia is a congenital X-linked recessive disease characterized by the lack or absence of clotting factors in the blood. Male individuals with problems in the X chromosome are affected, females are carriers. There are two common types, factor VIII (Hemophilia A) and factor IX (Hemophilia B), and the percentage of the exposed factor in circulation determines the degree of hemophilia disease (<1% severe, 1-5% moderate,> 20% mild). The most common clinical symptoms in hemophilia are intra-articular and intramuscular spontaneous bleeding, a history of bleeding that lasts longer than expected after trauma, hemarthrosis and hematomas after crawling or walking in children with moderate or severe hemophilia. Pain, swelling, redness, temperature increase and limitation of movement occur in the bleeding joint. Bleeding into the joint space causes inflammation in the synovial membrane and synovitis occurs. With chronic synovitis, the synovial membrane thickens. Degeneration of the joint cartilage and narrowing of the joint space occurs. Hemarthroses constitute 70-80% of bleeding findings. The most common bleeding joints are knee joints with a rate of 45%. Besides pharmacological treatment for joint and muscle bleeding, the most suitable option is exercise therapy.

The aim of our study is to examine the effect of exercise agitation on pain, physical activity and quality of life in pediatric hemophilia patients. The results of the study indicate that the exercise protocol developed for the lower extremity in pediatric hemophilia patients will have a positive effect on pain, physical activity and quality of life.

Enrollment

30 estimated patients

Sex

Male

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosed with hemophilia (Hemophilia A) by a hematologist
  • Hemophilia is moderate or severe, without spontaneous bleeding complaints
  • Having a history of bleeding in the knee joint
  • Not doing any regular exercise
  • Willing to continue working and will not start other treatment during the study
  • Patients whose parents were informed about the study and whose consent form was obtained

Exclusion criteria

  • Those who have undergone another surgery (joint debridement, fracture, knee replacement) that will affect lower extremity function
  • Those with neurological disease or any sensory loss or peripheral nerve injury that may affect functional performance and balance

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

Control group
No Intervention group
Description:
This group will not take any exercise intervention.
Traditional exercise training group
Active Comparator group
Description:
This group will get traditional therapy that is include range of motion exercises and resistance exercise training.
Treatment:
Other: Traditional exercise training
Specific exercise training group
Experimental group
Description:
This group will get a specific programme that combinated with closed kinetic chain exercises and core exercises training
Treatment:
Other: Specific exercise training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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