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

NCT ID: NCT05027503

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-19

Study Completion Date

2024-05-26

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Respiratory Physiotherapy

Intervention Type 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.

Training Group

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

Group Type EXPERIMENTAL

Exercise with hippotherapy simulator

Intervention Type 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.

Respiratory Physiotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Betül Çınar

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Betül Çınar

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

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Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IUCbcinar01

Identifier Type: -

Identifier Source: org_study_id

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