Clinical trial NCT04754997: Effect of Exercise in Pediatric Hemophilia
Official title: The Effect of Exercise Training on Pain, Physical Activity and Quality of Life in Pediatric Hemophilia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophilia A, Severe
Hemophilia Arthropathy
Keywords: Hemophilia
Factor VIII
Closed chain exercise
Knee
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 30
Sex: MALE
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were divided in three groups. Two groups will get two different intervention. One group will be the control group.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Pain
timeFrame: through of the study, average 12 weeks
measure: Functional ambulatory mobility
timeFrame: through of the study, average 12 weeks
measure: Functional exercise capacity
timeFrame: through of the study, average 12 weeks
measure: Lower extremity functional strength test
timeFrame: through of the study, average 12 weeks
measure: The quality of Life
timeFrame: through of the study, average 12 weeks
Secondary outcomes:
measure: Knee Proprioception
timeFrame: through of the study, average 12 weeks
measure: Joint Health
timeFrame: through of the study, average 12 weeks
measure: Functional Independence
timeFrame: through of the study, average 12 weeks
measure: Static Balance
timeFrame: through of the study, average 12 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
state: Şahinbey
Study officials:
References:
citation: van Vulpen LFD, Holstein K, Martinoli C. Joint disease in haemophilia: Pathophysiology, pain and imaging. Haemophilia. 2018 May;24 Suppl 6:44-49. doi: 10.1111/hae.13449.
citation: Wagner B, Kruger S, Hilberg T, Ay C, Hasenoehrl T, Huber DF, Crevenna R. The effect of resistance exercise on strength and safety outcome for people with haemophilia: A systematic review. Haemophilia. 2020 Mar;26(2):200-215. doi: 10.1111/hae.13938. Epub 2020 Feb 24.
citation: Siqueira TC, Dominski FH, Andrade A. Effects of exercise in people with haemophilia: An umbrella review of systematic reviews and meta-analyses. Haemophilia. 2019 Nov;25(6):928-937. doi: 10.1111/hae.13868. Epub 2019 Oct 30.
citation: Souza JC, Simoes HG, Campbell CS, Pontes FL, Boullosa DA, Prestes J. Haemophilia and exercise. Int J Sports Med. 2012 Feb;33(2):83-8. doi: 10.1055/s-0031-1286292. Epub 2011 Nov 17.