Skip to main content
Clinical Trials/NCT04754997
NCT04754997
Unknown
Not Applicable

The Effect of Exercise Training on Pain, Physical Activity and Quality of Life in Pediatric Hemophilia Patients

Hasan Kalyoncu University1 site in 1 country30 target enrollmentJanuary 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemophilia A, Severe
Sponsor
Hasan Kalyoncu University
Enrollment
30
Locations
1
Primary Endpoint
Lower extremity functional strength test
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2021
End Date
November 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Hasan Kalyoncu University
Responsible Party
Principal Investigator
Principal Investigator

Tuğba GÖNEN

Research Assistant

Hasan Kalyoncu University

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

Outcomes

Primary Outcomes

Lower extremity functional strength test

Time Frame: through of the study, average 12 weeks

Sit to stand test will used to determine physical activity. The sit-to-stand test measures time needed to complete three consecutive sit-to-stand cycles as quickly as possible. The higher the rate of three-repetition sit-to-stand (repetitions per second), the more strength a children has.

Functional exercise capacity

Time Frame: through of the study, average 12 weeks

Two minutes walk test will used to determine physical activity. 2-minute walk test (2MWT) is classified to represent the most suitable method to assess the submaximal level of functional exercise capacity in children. This test measures the distance that a patient or participant quickly walk on a flat, hard surface in a period of 2 minutes.If the covered distance is increased, that is mean functional capacity will worse.

The Pain

Time Frame: through of the study, average 12 weeks

Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

Functional ambulatory mobility

Time Frame: through of the study, average 12 weeks

Time Up and Go test will used to determine ambulatory mobility. Time up and go test required documenting the time in seconds that subjects required to: "rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, and sit down again." If relapsed time score is increased, that is mean mobility function will worse.

The quality of Life

Time Frame: through of the study, average 12 weeks

The Children's Quality of Life Scale ( PedsQL) will used to determine to quality of life level. The quality of life scale for children questions the last month of children and adolescents. It is a 5-point Likert-type scale with never 100 points, rarely 75 points, sometimes 50 points, often 25 points and always 0 points. The total score is obtained by dividing the scores obtained from the scale by the number of filled items. The higher the total score, the better the quality of life.

Secondary Outcomes

  • Joint Health(through of the study, average 12 weeks)
  • Knee Proprioception(through of the study, average 12 weeks)
  • Static Balance(through of the study, average 12 weeks)
  • Functional Independence(through of the study, average 12 weeks)

Study Sites (1)

Loading locations...

Similar Trials