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

NCT05027503 | Completed

• 1 other identifier: IUCbcinar01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• Biering Sorenson Test

  8 weeks

• Lateral Bridge Test

  8 weeks

• Trunk Flexion Test

  8 weeks

• m. quadriceps strength

  8 weeks

• Amount of sputum expelled (gr)

  8 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks

Other: Respiratory Physiotherapy

Training Group

EXPERIMENTAL

In addition to home-based respiratory physiotherapy, 30 min exercises with the hippotherapy simulator will be done.

Other: Exercise with hippotherapy simulator; Other: Respiratory Physiotherapy

Interventions

Exercise with hippotherapy simulator OTHER

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.

Training Group

Respiratory Physiotherapy OTHER

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.

Control Group; Training Group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Betül Çınar

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 30, 2021
• Study Start: December 19, 2021
• Primary Completion: February 19, 2024
• Study Completion: May 26, 2024
• Last Updated: February 5, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)