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

NCT07138157 | Completed

• 1 other identifier: IstanbuIUC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Familial Mediterranean Fever (FMF); Juvenile Dermatomyositis; Rheumatic Diseases; Juvenile Idiopathic Arthritis (JIA)

Keywords

Juvenile dermatomyositis; Exercise in pediatric rheumatic diseases; External focus; Internal focus

Outcome Measures

Primary Outcomes (3)

• Change in Physical Fitness

  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.

  8 weeks

• Change in Fatigue Severity

  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.

  8 weeks

• Change in Pain Intensity

  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.

  8 weeks

Secondary Outcomes (4)

• Change in Physical Activity Level (Children)

  8 weeks

• Change in Physical Activity Level (Adolescents)

  8 weeks

• Change in Functional Capacity

  8 weeks

• Change in Lower Extremity Strength

  8 weeks

Study Arms (2)

External Focus of Attention Group

ACTIVE COMPARATOR

In this group, the exercise program will be implemented using external focus in the commands and exercise instructions. During exercise, external focus commands are designed to direct attention toward the impact of the movement or an external stimulus. For example, during the squat exercise, the command "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.

Other: External Focus Exercises

Internal Focus of Attention Group

ACTIVE COMPARATOR

In this group, the exercise program will be implemented using internal focus in the commands and exercise instructions. During exercise, internal focus commands are designed to direct attention toward the body part performing the movement or the movement itself. For example, during the squat exercise, the command "Bend over by bending the knees without disturbing the straightness of the back" represents an internal focus command, whereas the command "Bend over as if sitting on a chair until the sign in front is no longer visible" represents an external focus command.

Other: Internal Focus Exercises

Interventions

External Focus Exercises OTHER

The commands given during the exercises will encourage the participants to focus their attention on the effect of the movement/ external focus of attention

External Focus of Attention Group

Internal Focus Exercises OTHER

The commands given in the second group will encourage the participants to focus their attention on the body part performing the movement/ Internal focus of attention

Internal Focus of Attention Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Istanbul University: collaborator

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Türkiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dermatomyositis; Rheumatic Diseases; Arthritis, Juvenile; Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Immune System Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: August 22, 2025
• Study Start: May 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)