Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05027503
Enrollment
32
Registered
2021-08-30
Start date
2021-12-19
Completion date
2024-05-26
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERExercise with hippotherapy simulator

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.

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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Forced Vital Capacity (FVC)8 weeksPulmonary Function Test
Forced Expiratory Volume in 1 second (FEV1)8 weeksPulmonary Function Test
Tiffeneau ratio (FEV1/FVC)8 weeksPulmonary Function Test
Peak Expiratory Flow (PEF)8 weeksPulmonary Function Test
Distance covered in six minute walk test8 weeksFunctional Capacity
Postural stability test score in Biodex Balance System SD8 weeksPostural Stability
Limits of stability test score in Biodex Balance System SD8 weeksPostural Stability

Secondary

MeasureTime frameDescription
Sense of chest congestion8 weeksSubjective evaluation method questioning sense of chest congestion with visual analog scale (0-10 point). A higher score indicates greater sense of chest congestion.
Cystic Fibrosis Questionnaire Revised (CFQ-R)8 weeksQuality 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.
Physical Activity Questionnaire for Children (PAQ-C)8 weeksPhysical Activity Level. As a result of the 9-item questionnaire, 1 means lowest and 5 means highest physical activity level.
Sit and reach test8 weeksFlexibility
Biering Sorenson Test8 weeksCore Muscles Endurance
Lateral Bridge Test8 weeksCore Muscles Endurance
Trunk Flexion Test8 weeksCore Muscles Endurance
m. quadriceps strength8 weeksPeripheral Muscle Strength
Amount of sputum expelled (gr)8 weeksSputum amount
Ease of expectoration8 weeksSubjective 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026