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

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 Overview

• Status: Completed
• Conditions: Cystic Fibrosis in Children
• Intervention / Treatment: Other: Respiratory Physiotherapy; Other: Exercise with hippotherapy simulator

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks	Other: Respiratory Physiotherapy; 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.
Experimental: Training Group; In addition to home-based respiratory physiotherapy, 30 min exercises with the hippotherapy simulator will be done.	Other: Respiratory Physiotherapy; 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.; Other: Exercise 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.

What is the study measuring?

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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of sputum expelled (gr)	Sputum amount	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

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Principal Investigator: Betül Çınar, Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2021
• Primary Completion (Actual): February 19, 2024
• Study Completion (Actual): May 26, 2024

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cystic fibrosis; respiratory physiotherapy; functional capacity; pulmonary functions; Postural stability; hippotherapy simulator; 6-Minute Walk Test; motor performance; sputum expectoration
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: IUCbcinar01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No