Effect of Exercise in Pediatric Hemophilia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2021-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hemophilia A, Severe Hemophilia Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were divided in three groups. Two groups will get two different intervention. One group will be the control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

This group will not take any exercise intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Traditional exercise training group

This group will get traditional therapy that is include range of motion exercises and resistance exercise training.

Group Type ACTIVE_COMPARATOR

Traditional exercise training

Intervention Type OTHER

The therapy program will planned for 12 weeks and the sessions will be performed in 45 minutes (min) for 2 days a week. The lower extremity range of motion exercise and strengthening exercises will be applied on the mat 10 repetition. The number of repetitions and type of exercises will be changed every 3 weeks.

Specific exercise training group

This group will get a specific programme that combinated with closed kinetic chain exercises and core exercises training

Group Type EXPERIMENTAL

Specific exercise training

Intervention Type OTHER

The therapy program will planned for 12 weeks and the sessions will be performed in 45 minutes (min) for 2 days a week. Exercise training consists of lower extremity closed kinetic chain exercises and core exercises. The type of exercise changes every 3 weeks.

Interventions

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Traditional exercise training

The therapy program will planned for 12 weeks and the sessions will be performed in 45 minutes (min) for 2 days a week. The lower extremity range of motion exercise and strengthening exercises will be applied on the mat 10 repetition. The number of repetitions and type of exercises will be changed every 3 weeks.

Intervention Type OTHER

Specific exercise training

The therapy program will planned for 12 weeks and the sessions will be performed in 45 minutes (min) for 2 days a week. Exercise training consists of lower extremity closed kinetic chain exercises and core exercises. The type of exercise changes every 3 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No