Investigation of the Effectiveness of the Hippotherapy Simulator Added to Respiratory Physiotherapy in Children and Adolescents with Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Forced Vital Capacity (FVC)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control Group
Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks
Intervention: Respiratory Physiotherapy (Other)
Training Group
In addition to home-based respiratory physiotherapy, 30 min exercises with the hippotherapy simulator will be done.
Intervention: Exercise with hippotherapy simulator (Other)
Training Group
In addition to home-based respiratory physiotherapy, 30 min exercises with the hippotherapy simulator will be done.
Intervention: Respiratory Physiotherapy (Other)
Outcomes
Primary Outcomes
Forced Vital Capacity (FVC)
Time Frame: 8 weeks
Pulmonary Function Test
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 8 weeks
Pulmonary Function Test
Tiffeneau ratio (FEV1/FVC)
Time Frame: 8 weeks
Pulmonary Function Test
Peak Expiratory Flow (PEF)
Time Frame: 8 weeks
Pulmonary Function Test
Distance covered in six minute walk test
Time Frame: 8 weeks
Functional Capacity
Postural stability test score in Biodex Balance System SD
Time Frame: 8 weeks
Postural Stability
Limits of stability test score in Biodex Balance System SD
Time Frame: 8 weeks
Postural Stability
Secondary Outcomes
- m. quadriceps strength(8 weeks)
- Amount of sputum expelled (gr)(8 weeks)
- Biering Sorenson Test(8 weeks)
- Lateral Bridge Test(8 weeks)
- Trunk Flexion Test(8 weeks)
- Ease of expectoration(8 weeks)
- Sense of chest congestion(8 weeks)
- Sit and reach test(8 weeks)
- Physical Activity Questionnaire for Children (PAQ-C)(8 weeks)
- Cystic Fibrosis Questionnaire Revised (CFQ-R)(8 weeks)
Investigators
Betül Çınar
Lecturer
Istanbul University - Cerrahpasa