跳至主要内容
临床试验/NCT04703062
NCT04703062已完成不适用

The Effects of Exercise Training on Physical Activity Level, Daily Living Activities and Participation in Children With Hemophilia

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Hemophilia Joint Health Scoring (HJHS)

研究概览

简要总结

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

详细描述

Hemophilia is defined as bleeding in the musculoskeletal system and soft tissues as a result of the lack of clotting factors in the blood. Recurrent attacks of hemarthrosis cause pain, also because of the pain patients tend to use joints less than usual. The decrease in joint movement makes it harder to return to active movement again. There is a limited literature on the effects of exercise on children with hemophilia.

Hemophilia is a hereditary bleeding disorder that develops as a result of factor VIII or IX deficiency; it is a rarely seen disease that discloses itself by hemarthrosis and intramuscular bleeding. Factor VIII deficiency is called Hemophilia A and Factor IX deficiency is called Hemophilia B. This disease is inherited by the X chromosome and passes on to male children through female carriers. Although Hemophilia A is observed rarely, one in about 5,000-10,000 male births, its frequency is still 5-6 times higher than Hemophilia B. Around 70% of hemophilia A patients have more severe disease, however, this rate is approximately 50% in hemophilia B.

Hemophilia patients experience bleeding in the musculoskeletal system and soft tissues as a result of the lack of clotting factors in the blood. Recurrent attacks of hemarthrosis cause pain, also because of the pain patients tend to use joints less than usual. Decrease in joint movement makes it harder to return to active movement again in the majority of the cases, bleeding occurs into the joint (mostly the knee, elbow and ankle) and only a small part of the bleedings occurs into the muscle (especially the iliopsoas, calf and forearm muscles).

In order to be able to participate according to the international classification of functions of health (ICF), it is prioritized that the activities are functional.

Targeted treatment is a functional treatment application that conforms to ICF's "activities and participation among children. An activity is carrying out of a task or movement by an individual and the difficulties faced while carrying out the tasks or movements is called limitations. Participation means the individual's being in life. In life conditions, problems confronted are participation restrictions. Activity limitations can often lead to participation restrictions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Hemophilia Joint Health Scoring (HJHS)

时间窗: through study completion, an average of 1 day

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.

Canadian Occupational Performance Measurement (COPM)

时间窗: through study completion, an average of 1 day

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.

BMI (body mass index)

时间窗: through study completion, an average of 1 day

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

muscle strength

时间窗: through study completion, an average of 1 day

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.

The Pediatric's Quality of life Scale (PedsQL)

时间窗: through study completion, an average of 1 day

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.

range of motion (ROM)

时间窗: through study completion, an average of 1 day

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

次要结局

  • Children's Functional Independence Scale (Wee-FIM)(through study completion, an average of 1 day)
  • 6 minutes walk test(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)
  • Long version of International Physical Activity Questionnaire (IPAQ)(through study completion, an average of 1 day)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Canan Atay

principal investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

Loading locations...

相似试验