Clinical trial NCT05027503: Effectiveness of the Hippotherapy Simulator in Children and Adolescents with Cystic Fibrosis
Official title: Investigation of the Effectiveness of the Hippotherapy Simulator Added to Respiratory Physiotherapy in Children and Adolescents with Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis in Children
Keywords: cystic fibrosis
hippotherapy simulator
pulmonary functions
sputum expectoration
functional capacity
6-Minute Walk Test
Postural stability
motor performance
respiratory physiotherapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 8 weeks
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 8 weeks
measure: Tiffeneau ratio (FEV1/FVC)
timeFrame: 8 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: 8 weeks
measure: Distance covered in six minute walk test
timeFrame: 8 weeks
measure: Postural stability test score in Biodex Balance System SD
timeFrame: 8 weeks
measure: Limits of stability test score in Biodex Balance System SD
timeFrame: 8 weeks
Secondary outcomes:
measure: Biering Sorenson Test
timeFrame: 8 weeks
measure: Lateral Bridge Test
timeFrame: 8 weeks
measure: Trunk Flexion Test
timeFrame: 8 weeks
measure: m. quadriceps strength
timeFrame: 8 weeks
measure: Amount of sputum expelled (gr)
timeFrame: 8 weeks
measure: Ease of expectoration
timeFrame: 8 weeks
measure: Sense of chest congestion
timeFrame: 8 weeks
measure: Sit and reach test
timeFrame: 8 weeks
measure: Physical Activity Questionnaire for Children (PAQ-C)
timeFrame: 8 weeks
measure: Cystic Fibrosis Questionnaire Revised (CFQ-R)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Betül Çınar
role: PRINCIPAL_INVESTIGATOR
References: