Effectiveness of the Hippotherapy Simulator in Children and Adolescents With Cystic Fibrosis

Study Overview
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Brief Summary
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Cystic fibrosis (CF) is a genetic disease that affects many organs and systems, especially respiratory system problems due to lung damage. Patients often have difficulty in removing the sticky and viscous secretion that accumulates in the respiratory tract, and the risk of mortality increases with the development of respiratory failure. In patients with CF, exercise capacity, peripheral muscle strength, core endurance, flexibility, postural stability, physical activity level, and quality of life also decrease secondarily. Recently published guidelines recommend respiratory physiotherapy for coping with CF-related symptoms and recommend referral of patients to physical activity and exercise. Hippotherapy simulator is a mechanical exercise tool that imitates the walking movement of a real horse and is used to increase physical fitness parameters. This study aims to show the effects of exercises performed with a hippotherapy simulator in addition to respiratory physiotherapy on physical fitness, sputum production, physical activity and quality of life of children with CF.

Official Title
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Investigation of the Effectiveness of the Hippotherapy Simulator Added to Respiratory Physiotherapy in Children and Adolescents With Cystic Fibrosis

Conditions
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Cystic Fibrosis in Children

Intervention / Treatment
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* Other: Exercise with hippotherapy simulator
* Other: Respiratory Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be in the 8-14 age range To be diagnosed with cystic fibrosis according to the American Cystic Fibrosis Association consensus report criteria Having mild (FEV1 ≥ 70% predictive) lung disease according to the disease severity classification in the annual report of the American Cystic Fibrosis Society To be able to produce phlegm Exclusion Criteria: Contracture or deformity, History of diagnosed orthopedic problems affecting mobility or musculoskeletal surgery History of previous lung or liver transplant Have diagnosed vision, hearing, vestibular or neurological problems that may affect balance, History of hospitalization in the last 1 month Patients who have participated in any exercise training program in the last 6 months

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks | Other: Respiratory Physiotherapy<br>* Respiratory physiotherapy includes breathing control (5x2), diaphragmatic breathing exercises (5x2), thoracic expansion exercises (5x2), incentive spirometer (5x2), opep device (5x2), postural drainage and percussion and cough improvement techniques (10 min). Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks.<br>|
| Experimental: Training Group<br>In addition to home-based respiratory physiotherapy, 30 min exercises with the hippotherapy simulator will be done. | Other: Exercise with hippotherapy simulator<br>* 30-minute (5 min warm-up+20 min exercise+5 min cool-down) center-based exercise with the hippotherapy simulator will be done 2 days a week for 8 weeks.<br>Other: Respiratory Physiotherapy<br>* Respiratory physiotherapy includes breathing control (5x2), diaphragmatic breathing exercises (5x2), thoracic expansion exercises (5x2), incentive spirometer (5x2), opep device (5x2), postural drainage and percussion and cough improvement techniques (10 min). Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Vital Capacity (FVC) | Pulmonary Function Test | 8 weeks | 
| Forced Expiratory Volume in 1 second (FEV1) | Pulmonary Function Test | 8 weeks | 
| Tiffeneau ratio (FEV1/FVC) | Pulmonary Function Test | 8 weeks | 
| Peak Expiratory Flow (PEF) | Pulmonary Function Test | 8 weeks | 
| Distance covered in six minute walk test | Functional Capacity | 8 weeks | 
| Amount of sputum expelled (gr) | Sputum amount | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural stability test score in Biodex Balance System SD | Postural Stability | 8 weeks | 
| Limits of stability test score in Biodex Balance System SD | Postural Stability | 8 weeks | 
| Sit and reach test | Flexibility | 8 weeks | 
| m. quadriceps strength | Peripheral Muscle Strength | 8 weeks | 
| Biering Sorenson Test | Core Muscles Endurance | 8 weeks | 
| Lateral Bridge Test | Core Muscles Endurance | 8 weeks | 
| Trunk Flexion Test | Core Muscles Endurance | 8 weeks | 
| Physical Activity Questionnaire for Children (PAQ-C) | Physical Activity Level. As a result of the 9-item questionnaire, 1 means lowest and 5 means highest physical activity level. | 8 weeks | 
| Cystic Fibrosis Questionnaire Revised (CFQ-R) | Quality of Life Assessment. In this questionnaire, which consists of 35 questions, the total score is 100, and a higher score indicates a better quality of life. | 8 weeks | 
| Sense of chest congestion | Subjective evaluation method questioning sense of chest congestion with visual analog scale (0-10 point). A higher score indicates greater sense of chest congestion. | 8 weeks | 
| Ease of expectoration | Subjective assessment that evaluates how hard the person has during sputum production with a visual analog scale (0-10 point). A high score means that it is easy to sputum. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, hippotherapy simulator, pulmonary functions, sputum expectoration, functional capacity, 6-Minute Walk Test, Postural stability, motor performance, respiratory physiotherapy