Effect of Exercise in Pediatric Hemophilia

NCT04754997 | Unknown DMC

• 1 other identifier: 2020/116
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemophilia A, Severe; Hemophilia Arthropathy

Keywords

Hemophilia; Factor VIII; Closed chain exercise; Knee

Outcome Measures

Primary Outcomes (5)

• The Pain

  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.

  through of the study, average 12 weeks

• Functional ambulatory mobility

  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.

  through of the study, average 12 weeks

• Functional exercise capacity

  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.

  through of the study, average 12 weeks

• Lower extremity functional strength test

  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.

  through of the study, average 12 weeks

• The quality of Life

  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.

  through of the study, average 12 weeks

Secondary Outcomes (4)

• Knee Proprioception

  through of the study, average 12 weeks

• Joint Health

  through of the study, average 12 weeks

• Functional Independence

  through of the study, average 12 weeks

• Static Balance

  through of the study, average 12 weeks

Study Arms (3)

Control group

NO INTERVENTION

This group will not take any exercise intervention.

Traditional exercise training group

ACTIVE COMPARATOR

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

Other: Traditional exercise training

Specific exercise training group

EXPERIMENTAL

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

Other: Specific exercise training

Interventions

Traditional exercise training 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.

Traditional exercise training group

Specific exercise training 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.

Specific exercise training group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Gender Eligibility Details: Hemophilia a disease is an X-linked recessive disease. Therefore, girls become carriers and do not show muscle joint problems.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 29878659 BACKGROUND

• 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.

  PMID: 32091659 BACKGROUND

• 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.

  PMID: 31667968 BACKGROUND

• 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.

  PMID: 22095329 BACKGROUND

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

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

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 15, 2021
• Study Start: January 16, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 30, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)