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临床试验/NCT07138157
NCT07138157已完成不适用

Comparison Of The Effects Of Two Different Exercise Training Based On Internal And External Focus In Children and Adolescents With Rheumatic Diseases

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年5月1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
28
试验地点
1
主要终点
Change in Physical Fitness

研究概览

简要总结

The study aims to compare the effects of two different exercise programs, based on distinct focus strategies, on physical fitness and fatigue in children and adolescents with rheumatic diseases. Participants will include individuals diagnosed with Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), and Familial Mediterranean Fever (FMF), monitored at Istanbul University, Istanbul Faculty of Medicine, in collaboration with Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. After baseline assessments, participants will be randomly allocated into two groups. One group will receive an exercise program with commands and instructions emphasizing external focus, while the other group will follow a program emphasizing internal focus. Both exercise interventions will last for 8 weeks, consisting of two online supervised sessions and one home-based session per week under family supervision. Final evaluations will be conducted at the clinic after completion of the intervention period.

详细描述

Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM) and Familial Mediterranean Fever (FMF) patients who were monitored at Istanbul University Istanbul Faculty of Medicine under the supervision of Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation will be included in this study. Demographic data of the participants, including age, weight, height, body mass index, age of onset of the disease, time elapsed before diagnosis, duration of symptoms, family history, will be recorded. Participants' physical fitness, muscle strength and functions, physical activity levels, fatigue and pain levels will be evaluated face-to-face at the beginning and at the end of the 8-week exercise program. The FitnessGram test battery will be used for the physical fitness assessment. The 'Fatigue Severity Scale' will be used to assess the fatigue levels of the participants. Physical activity levels will be evaluated separately in children and adolescents using the 'Physical Activity in Adolescents Questionnaire' and the 'Physical Activity in Children Questionnaire'. In all cases, pain severity will be questioned using the 'Visual Analog Scale'. All participants will be given a 6 Minute Walk Test to measure their functional capacity, 30 Seconds Sit to Stand Test to measure their lower extremity strength.

Following to first evaluation, the patients will be randomly assigned to two groups. In the first group, the exercise program will be applied as the basis of external focus in the commands and exercise instructions directed to the patient, while in the second group, the exercise program will be applied as the basis of internal focus. Exercise training in both groups lasted 8 weeks; It will be applied 3 days a week, two sessions each week under the supervision of an online physiotherapist and one session with online family supervision. Online training sessions will be conducted via Google Meets. In the first group, the exercise program will be applied based on the external focus, while in the second group, the exercise program will be applied on the basis of the internal focus. The same exercise program will be applied in both groups, but in the first group, the commands given during the exercises will encourage the participants to focus their attention on the effect of the movement, while the commands given in the second group will encourage the participants to focus their attention on the body part performing the movement. In the squat exercise, for instance, the first group is instructed to "Bend over as if sitting on a chair until the sign in front is no longer visible" represents an external focus command, whereas the command "Bend over by bending the knees without disturbing the straightness of the back" represents an internal focus command.

Exercise training in both groups last 8 weeks; two sessions each week online via Google Meets and third session will be held under family supervision. At the end of 8 weeks, participants will be called back to the clinic for a final evaluation.

研究设计

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

入排标准

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

入选标准

  • Juvenile Dermatomyositis: Being diagnosed with JDM according to the Bohan and Peter Criteria by a pediatric rheumatologist
  • Familial Mediterranean Fever: Having been diagnosed with FMF at least 6 months ago
  • JIA: Having been diagnosed with JIA according to the ILAR classification
  • Not having visual impairment or hearing impairment
  • Being at a mental level that can adapt to the exercise program
  • Having internet connection

排除标准

  • Having any systemic chronic disease other than JIA, FMF, or JDM
  • Having any musculoskeletal disease or an orthopedic, neurological, psychological disease that may interfere with participation in exercise
  • Having developed amyloidosis
  • Having undergone surgery affecting the musculoskeletal system in the last 6 months
  • Having visual impairment or hearing impairment
  • Not having internet connection

结局指标

主要结局

Change in Physical Fitness

时间窗: 8 weeks

Overall physical fitness will be assessed using the FitnessGram Physical Activity Test Battery, a validated tool for evaluating health-related fitness components in children and adolescents. The battery includes subtests to measure cardiovascular endurance (PACER test), muscular strength and endurance (curl-up, push-up), and flexibility (sit-and-reach). Each subtest will be scored separately according to criterion-referenced health standards established for children and adolescents. Changes in performance scores from baseline to 8 weeks will be analyzed to determine the effectiveness of the intervention on physical fitness.

Change in Fatigue Severity

时间窗: 8 weeks

Fatigue severity will be assessed using Fatigue Severity Scale (FSS), which is validated tools for measuring perceived fatigue intensity and its impact on daily functioning. The FSS comprises nine items rated on a 7-point Likert scale, with a mean score ≥4 considered indicative of substantial fatigue. The change from baseline to post-intervention will be analyzed. This outcome will provide a quantitative evaluation of the intervention's effectiveness in mitigating clinically relevant fatigue in the target population.

Change in Pain Intensity

时间窗: 8 weeks

Pain intensity will be evaluated using the Visual Analog Scale (VAS), a reliable and validated tool commonly used in both clinical and research settings. Participants will be asked to rate their pain on a 10 cm horizontal line, where 0 cm indicates "no pain" and 10 cm represents "worst imaginable pain." A decrease of at least 2 cm is generally considered to be clinically meaningful. Changes in VAS pain scores from baseline to the end of the intervention will be analyzed to determine the intervention's impact on pain.

次要结局

  • Change in Physical Activity Level (Children)(8 weeks)
  • Change in Functional Capacity(8 weeks)
  • Change in Physical Activity Level (Adolescents)(8 weeks)
  • Change in Lower Extremity Strength(8 weeks)

研究者

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

Aleyna Yilmaz

Physiotherapist

Istanbul University - Cerrahpasa

研究点 (1)

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