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

Cystic Fibrosis in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027503
• Other study ID #: IUCbcinar01
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2021
• Est. completion date: June 21, 2024

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Betül Çinar, MSc
• Phone: +905327879969
• Email: betulbirik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 21, 2024
• Est. primary completion date: February 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis in Children
• Fibrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Vital Capacity (FVC)	Pulmonary Function Test	8 weeks
Primary	Forced Expiratory Volume in 1 second (FEV1)	Pulmonary Function Test	8 weeks
Primary	Tiffeneau ratio (FEV1/FVC)	Pulmonary Function Test	8 weeks
Primary	Peak Expiratory Flow (PEF)	Pulmonary Function Test	8 weeks
Primary	Distance covered in six minute walk test	Functional Capacity	8 weeks
Primary	Amount of sputum expelled (gr)	Sputum amount	8 weeks
Secondary	Postural stability test score in Biodex Balance System SD	Postural Stability	8 weeks
Secondary	Limits of stability test score in Biodex Balance System SD	Postural Stability	8 weeks
Secondary	Sit and reach test	Flexibility	8 weeks
Secondary	m. quadriceps strength	Peripheral Muscle Strength	8 weeks
Secondary	Biering Sorenson Test	Core Muscles Endurance	8 weeks
Secondary	Lateral Bridge Test	Core Muscles Endurance	8 weeks
Secondary	Trunk Flexion Test	Core Muscles Endurance	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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