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

Primary Purpose

Cystic Fibrosis in Children

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise with hippotherapy simulator
Respiratory Physiotherapy
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis in Children focused on measuring cystic fibrosis, hippotherapy simulator, pulmonary functions, sputum expectoration, functional capacity, 6-Minute Walk Test, Postural stability, motor performance, respiratory physiotherapy

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Forced Vital Capacity (FVC)
Pulmonary Function Test
Forced Expiratory Volume in 1 second (FEV1)
Pulmonary Function Test
Tiffeneau ratio (FEV1/FVC)
Pulmonary Function Test
Peak Expiratory Flow (PEF)
Pulmonary Function Test
Distance covered in six minute walk test
Functional Capacity
Amount of sputum expelled (gr)
Sputum amount

Secondary Outcome Measures

Postural stability test score in Biodex Balance System SD
Postural Stability
Limits of stability test score in Biodex Balance System SD
Postural Stability
Sit and reach test
Flexibility
m. quadriceps strength
Peripheral Muscle Strength
Biering Sorenson Test
Core Muscles Endurance
Lateral Bridge Test
Core Muscles Endurance
Trunk Flexion Test
Core Muscles Endurance
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.
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.
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.
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.

Full Information

First Posted
August 19, 2021
Last Updated
September 26, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05027503
Brief Title
Effectiveness of the Hippotherapy Simulator in Children and Adolescents With Cystic Fibrosis
Official Title
Investigation of the Effectiveness of the Hippotherapy Simulator Added to Respiratory Physiotherapy in Children and Adolescents With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2021 (Actual)
Primary Completion Date
December 19, 2023 (Anticipated)
Study Completion Date
May 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks
Arm Title
Training Group
Arm Type
Experimental
Arm Description
In addition to home-based respiratory physiotherapy, 30 min exercises with the hippotherapy simulator will be done.
Intervention Type
Other
Intervention Name(s)
Exercise with hippotherapy simulator
Intervention Description
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
Intervention Name(s)
Respiratory Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
Pulmonary Function Test
Time Frame
8 weeks
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Pulmonary Function Test
Time Frame
8 weeks
Title
Tiffeneau ratio (FEV1/FVC)
Description
Pulmonary Function Test
Time Frame
8 weeks
Title
Peak Expiratory Flow (PEF)
Description
Pulmonary Function Test
Time Frame
8 weeks
Title
Distance covered in six minute walk test
Description
Functional Capacity
Time Frame
8 weeks
Title
Amount of sputum expelled (gr)
Description
Sputum amount
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Postural stability test score in Biodex Balance System SD
Description
Postural Stability
Time Frame
8 weeks
Title
Limits of stability test score in Biodex Balance System SD
Description
Postural Stability
Time Frame
8 weeks
Title
Sit and reach test
Description
Flexibility
Time Frame
8 weeks
Title
m. quadriceps strength
Description
Peripheral Muscle Strength
Time Frame
8 weeks
Title
Biering Sorenson Test
Description
Core Muscles Endurance
Time Frame
8 weeks
Title
Lateral Bridge Test
Description
Core Muscles Endurance
Time Frame
8 weeks
Title
Trunk Flexion Test
Description
Core Muscles Endurance
Time Frame
8 weeks
Title
Physical Activity Questionnaire for Children (PAQ-C)
Description
Physical Activity Level. As a result of the 9-item questionnaire, 1 means lowest and 5 means highest physical activity level.
Time Frame
8 weeks
Title
Cystic Fibrosis Questionnaire Revised (CFQ-R)
Description
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.
Time Frame
8 weeks
Title
Sense of chest congestion
Description
Subjective evaluation method questioning "sense of chest congestion" with visual analog scale (0-10 point). A higher score indicates greater sense of chest congestion.
Time Frame
8 weeks
Title
Ease of expectoration
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Betül Çınar, MSc
Phone
+905327879969
Email
betulbirik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Betül Çınar, MSc
Phone
+902124531700
Ext
4648
Email
bcinar@bezmialem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betül Çınar
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betul Cinar
Phone
+902122110623
Ext
4648
Email
betulbirik@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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