The Effects of Exercise Training in Children With Hemophilia

NCT04703062 | Completed

• 1 other identifier: 13022260-300-63450
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of an individually planned exercise program, counseling and family education on the followings in patients with hemophilia (PWH);

1. 1.To examine the joint range of motion, muscle strength and functional status.
2. 2.To evaluate the level of physical activity and daily living activities
3. 3.To aim to determine the amount of change after participation.

Conditions

Hemophilia

Keywords

hemophilia; exercise; participation; physical activity; muscle strength

Outcome Measures

Primary Outcomes (6)

• Hemophilia Joint Health Scoring (HJHS)

  Because hemophilic individuals have a high risk of arthropathy, joints with bleeding should be examined very closely and arthropathic diagnosis should be detected at an early stage. For this reason, the HJHS was developed by the Physiotherapy Subgroup of the International Prophylaxis Working Group, this groups is made up of expert physiotherapists, rheumatologists and hematologists. It has been stated that HJHS is more sensitive than X-ray in diagnosing arthropathy findings, and it is used for about 40-60 minutes. Also, it has been reported that MRI and ultrasonography are not sufficient in joint evaluation when they are used alone; It has been shown that it should be performed together with HESS. The maximum disease score for each joint is 20, with a possible total score of 120, plus a maximum of four for global gait. High score means worse joint health.

  through study completion, an average of 1 day

• BMI (body mass index)

  Weight and height will be combined to report BMI in kg/m\^2. Underweight = \<18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9. Obesity = BMI of 30 or greater

  through study completion, an average of 1 day

• Canadian Occupational Performance Measurement (COPM)

  An individual-oriented self-assessment report in the COPM will be used to test participation restrictions. An increase in performance and satisfaction score means that the patient has improved his/her performance in doing the activity and that he/she has an increased satisfaction over this performance. It is a generic measure suitable for all clients with perceived problems in daily activities. The COPM results in two scores (performance and satisfaction) each of 10. The patient prioritizes up to five problems she/he deems are the most urgent or important and rates the problems on an ordinary 10-point scale regarding performance (1=not able to do at all and 10=able to do extremely well) and satisfaction (1=not satisfied at all and 10=extremely satisfied). Performance and satisfaction scores for the top 5 activities were summed and divided by the number of activities, resulting in total performance and satisfaction scores.

  through study completion, an average of 1 day

• range of motion (ROM)

  Elbow, knee and ankle flexion and extension active ROM are measured using a universal goniometer. In this study, 3 repetitions are performed in each direction, and the average value is recorded for analysis. Interrater reliability of measurements of ROM for upper extremity joints were ICC = 0.75.15

  through study completion, an average of 1 day

• muscle strength

  The muscle strength of elbow, knee and ankle flexor and extensors are measured using a hand-held dynamometer (The Lafayette Instrument Company). The measurements are recorded in kg/N. This dynamometer allowed a measurement of muscle strength from 0.0 to 199.9 kg, with 0.1 kg precision. The test participants are asked to forcibly contract their muscle while a resistive force is applied by the dynamometer in the opposite direction of the intended movement. During the test, the device recorded the maximal isometric strength of the muscle in kg/N. Each muscle is assessed 3 times, and the mean value is calculated. Test-retest reliability in hand-held dynamometry in children has been reported, and test-retest correlation coefficients ranged from 0.74 to 0.99 in their study.

  through study completion, an average of 1 day

• The Pediatric's Quality of life Scale (PedsQL)

  PedsQL will be evaluated with the quality of life for children scale. The parent form will be filled by the person two takes care of the child and the child from will be filled by the child who participated to the study these forms will be filled separately and simultaneously. Scoring will be made in 3 areas. First of all the overall score of the scale will be calculated, second the physical health score will be calculated and third the psychosocial health total score which consists of emotional, social and school functionality scores will be calculate. The scale consists of child self-report and parent proxy reports. The scale includes a total of 23 items. The total scale score, physical health summary score, and psychosocial health summary score were calculated. Items were scored between 0 and 100: 0 (100) = never a problem; 1 = (75) almost never; 2 = (50) sometimes; 3 = (25) almost always; and 4 = (0) always. Higher PedsQL scores indicate better HRQoL.

  through study completion, an average of 1 day

Secondary Outcomes (5)

• Long version of International Physical Activity Questionnaire (IPAQ)

  through study completion, an average of 1 day

• 6 minutes walk test

  through study completion, an average of 1 day

• Children's Functional Independence Scale (Wee-FIM)

  through study completion, an average of 1 day

• Sit-and-Stand Test

  through study completion, an average of 1 day

• Jebsen Taylor Hand Function Test

  through study completion, an average of 1 day

Study Arms (2)

Experimental group 1

EXPERIMENTAL

physical activity counseling group + exercise group

Behavioral: Experimental group 1

Experimental group 2

EXPERIMENTAL

physical activity counseling group

Behavioral: Experimental group 2

Interventions

Experimental group 1 BEHAVIORAL

It is planned to do exercises for 50 minutes a day, 2 days a week during 8 weeks with physiotherapist. It will be planned individually according to the needs of the patients. Exercises will progress in the following weeks by changing the number of repetitions, the amount of resistance and the amount of time. Counseling about physical activity and the suggested sports activity will be provided. In daily living activities ergonomics and joint protection principles will be taught. Informing Family.

Also known as: exercise

Experimental group 1

Experimental group 2 BEHAVIORAL

Counseling about physical activity and the suggested sports activity will be provided.Patients make aerobic and strengthening exercises by himself based on physiotherapist's suggestions. Informing Family about; Why are the exercises necessary To what extent the families should be protective The harmful effects of inactivity There will be information about the resting-activity cycle when there is bleeding.

Experimental group 2

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being in the 7-18 age range
• Being diagnosed with hemophilia A or B
• Having an ongoing prophylactic treatment
• Having a heavy or middle Factor level
• Volunteering to exercise at 2 days a week in the intervention group within the scope of the research
• Being able to communicate in Turkish written and verbal

You may not qualify if:

• Being in period of active bleeding
• Having Body mass index over 30 kg / m²
• Having an additional neurological diagnosis that will influence work and cooperation

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Canan Atay

Istanbul, 34188, Turkey (Türkiye)

Location

Related Links

• An institutional pilot study to investigate physical activity patterns in boys with haemophilia
• Physical exercise, pain and musculoskeletal function in patients with haemophilia
• Effects of a 6-week, individualized, supervised exercise program for people with bleeding disorders and hemophilic arthritis
• Exercise may decrease further destruction in the adult haemophilic joint.
• Guidelines for the management of hemophilia

MeSH Terms

Conditions

Hemophilia A; Motor Activity

Interventions

Exercise

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; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ela Tarakcı, prof dr

  Istanbul University- Cerrahpasa Physiotherapy and Rehabilitation Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: February 20, 2020
• Primary Completion: November 20, 2021
• Study Completion: March 20, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)