- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07661069
YOGA FOR CHILDREN WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA)
INVESTIGATING THE EFFECTIVENESS OF TELEREHABILITATION-BASED YOGA EXERCISES IN CHILDREN WITH JUVENILE IDIOPATHIC ARTHRITIS
Przegląd badań
Status
Szczegółowy opis
Juvenile Idiopathic Arthritis (JIA) is characterized by chronic inflammation that manifests in symptoms such as pain, swelling, movement restriction, and growth retardation. Clinical evidence suggests that exercise interventions, including aerobic and strengthening programs, provide significant benefits for pain management, range of motion (ROM), and quality of life in this population.
Yoga is a traditional exercise discipline that integrates breathing techniques (Pranayama), physical postures (Asanas), and meditation (Dhyana). Due to its adaptable nature and minimal equipment requirements, it has gained popularity as a therapeutic intervention. This study utilizes a telerehabilitation-based approach to deliver yoga to children with JIA, ensuring accessibility and professional guidance at home.
The Intervention Protocol:
Participants will undergo a specialized yoga program twice a week for 8 weeks. Each session will last 45 minutes and will be conducted one-on-one by two physiotherapists certified in "Yoga for Children" via the Zoom platform. The protocol is based on established literature.
Each session follows a structured sequence:
Introduction: Diaphragmatic breathing exercises. Main Phase: Progressive yoga postures (moving from simple to complex). Postures will be held for 2-3 breaths initially, progressing up to 10 breaths as the child's tolerance increases.
Closing: Relaxation and meditation.
List of Yoga Postures to be Utilized:
Mountain Pose, Crescent Pose (Starting positions) Star Pose, Tree Pose, Eagle Pose Bumblebee and Camel Pose Warrior I, II, and III Poses Triangle Pose, Horse Pose Lunge Pose, Butterfly Pose Frog, Pigeon, Turtle, and Basket Poses Diamond and Candle Poses Tiger Pose, Boat Pose Cat-Cow Pose, Reversed Hedgehog Pose Bridge, Rabbit, Child's Pose, and Plank. During transitions, children will be allowed rest periods as needed. The focus will remain on the synchronization of breath and movement throughout the intervention.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Being between 8 and 12 years of age.
- Diagnosed with Juvenile Idiopathic Arthritis (JIA) by a pediatric rheumatologist.
- Having no major changes in pharmacological treatment within the last 3 months.
- Having reliable internet access and the necessary technological equipment to participate in online video sessions.
- Voluntary participation in the study.
- Providing written parental informed consent and child assent.
Exclusion Criteria:
- Being in an acute disease flare-up/attack period.
- Having undergone orthopedic surgery within the last 6 months.
- Presence of severe cardiopulmonary or neurological conditions that contraindicate participating in yoga exercises.
- Cognitive level or impairment that prevents the child from following instructions and verbal cues.
- Regular participation in another structured exercise or physical rehabilitation program.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Telerehabilitation-Based Yoga Group
Participants will be allocated to this group using block randomization based on age and body mass index (BMI).
This group will participate in a telerehabilitation-based yoga program for 8 weeks, 2 days per week, with each session lasting 45 minutes.
The sessions will be conducted one-on-one, in real-time, via the Zoom platform, led by certified physiotherapists.
The structured program includes diaphragmatic breathing techniques, progressive pediatric-focused yoga postures (asanas), and relaxation/meditation phases.
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An 8-week, home-based virtual yoga program designed specifically for pediatric populations with chronic conditions. Sessions are conducted 2 days per week for 45 minutes each. The intervention is delivered live, face-to-face, and one-on-one via the Zoom platform by two physiotherapists certified in "Yoga for Children." Each session follows a standardized sequence:
Difficulty and repetitions are adapted weekly based on the individual child's physical capacity and comfort. |
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Aktywny komparator: Home-Based Exercise Control Group
Participants will be allocated to this group using block randomization based on age and body mass index (BMI).
This control group will follow a standard, home-based physical exercise program.
The exercises will be performed independently at home by the children, with family supervision, during the 8-week study period.
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An 8-week structured home exercise program consisting of standard physical therapy exercises conventionally recommended for children with juvenile idiopathic arthritis.
The protocol includes gentle stretching to maintain joint range of motion, low-impact strengthening exercises for major muscle groups, and basic posture/balance training.
Participants perform these exercises independently at home, under parental supervision, to match the 8-week timeline of the intervention group.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Functional Reach Test (FRT)
Ramy czasowe: Baseline (Week 0) and Post-intervention (Week 8)
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This test evaluates dynamic balance and limits of stability.
Participants stand barefoot or with flat-molded shoes parallel to a wall, with the shoulder flexed at 90 degrees and the arm extended forward to establish a baseline.
For the forward reach, participants reach as far forward as possible without taking a step.
The distance between the initial and final positions is measured in centimeters (cm).
The test is repeated three times, and the average score is recorded.
Higher scores indicate better dynamic balance and stability.
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Baseline (Week 0) and Post-intervention (Week 8)
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1-Minute Sit-to-Stand Test (1STST)
Ramy czasowe: Baseline (Week 0) and Post-intervention (Week 8)
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This test assesses lower extremity muscle endurance and functional capacity.
Participants sit on a standard-height chair with their arms crossed over their chest.
Upon the "start" command, they perform as many full sit-to-stand repetitions as possible within 1 minute.
The number of correctly completed repetitions is recorded.
Higher repetition counts indicate superior lower extremity muscular endurance.
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Baseline (Week 0) and Post-intervention (Week 8)
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Lateral reach test
Ramy czasowe: Baseline (Week 0) and Post-intervention (Week 8)
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This test evaluates dynamic balance.
The patricipants leaning against the wall with the shoulder flexed at 90 degrees and the arm extended forward to establish a baseline.
For the test, they reach as far sideways as possible without trunk rotation.
The distance between the initial and final positions is measured in centimeters (cm).
The test is repeated three times, and the average score is recorded.
Higher scores indicate better dynamic balance and stability.
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Baseline (Week 0) and Post-intervention (Week 8)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Biering-Sorensen Test for Trunk Extensor Endurance
Ramy czasowe: Baseline (Week 0) and Post-intervention (Week 8)
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This test evaluates the isometric endurance of the trunk extensor muscles.
Participants lie prone on an examination table with their pelvis, hips, and lower extremities secured.
The upper trunk is positioned horizontally off the edge of the table, and participants are instructed to maintain this unsupported horizontal position for as long as possible.
The duration for which the position is maintained is recorded in seconds.
Longer duration indicates better back extensor muscle endurance.
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Baseline (Week 0) and Post-intervention (Week 8)
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Sit-and-Reach Test
Ramy czasowe: Baseline (Week 0) and Post-intervention (Week 8)
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This test measures the flexibility of the hamstring muscles and the lumbar spine.
Participants sit in a long-sitting position with knees fully extended and bare feet placed flat against the testing box.
They reach forward with both hands as far as possible without bending the knees.
The maximum distance reached by the fingertips is recorded in centimeters (cm).
The best trial out of three attempts is used for evaluation.
Higher values represent better hamstring and lower back flexibility.
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Baseline (Week 0) and Post-intervention (Week 8)
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Curl-Up Test for Abdominal Endurance
Ramy czasowe: Baseline (Week 0) and Post-intervention (Week 8)
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This test is utilized to assess abdominal muscle endurance.
Participants lie in a supine position with knees flexed and feet secured.
They are instructed to perform as many correct curl-ups as possible within a specified standard time or cadence.
The total number of correctly executed repetitions within the time frame is recorded.
A higher number of repetitions indicates greater abdominal muscle endurance.
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Baseline (Week 0) and Post-intervention (Week 8)
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Push-Up Test for Upper Body Endurance
Ramy czasowe: Baseline (Week 0) and Post-intervention (Week 8)
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This test evaluates upper extremity and shoulder girdle muscular endurance.
Participants start in a prone plank position with hands shoulder-width apart and a straight trunk.
They perform consecutive push-ups using proper elbow flexion-extension technique.
Modified push-ups (e.g., knee push-ups) may be applied depending on the child's age and physical capacity.
The total number of correctly completed repetitions is recorded.
Higher counts reflect better upper body muscular endurance.
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Baseline (Week 0) and Post-intervention (Week 8)
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Physical Activity Questionnaire for Children (PAQ-C) Score
Ramy czasowe: Baseline (Week 0) and Post-intervention (Week 8)
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This self-reported questionnaire evaluates the general physical activity levels of children over the past 7 days.
It assesses the frequency of participation in physical activities during school hours, after school, and on weekends.
Items are scored on a 5-point scale, and a total composite score is calculated (ranging from 1 to 5).
Higher total scores indicate a higher level of habitual physical activity.
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Baseline (Week 0) and Post-intervention (Week 8)
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025YG
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Telerehabilitation-Based Yoga Group
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