Cystic Fibrosis in ChildrenNCT05027503
Effectiveness of the Hippotherapy Simulator in Children and Adolescents with Cystic Fibrosis
A study testing Exercise with hippotherapy simulator and Respiratory Physiotherapy in people with Cystic Fibrosis in Children, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- Exercise with hippotherapy simulator and Respiratory Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2021to 26 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- Exercise with hippotherapy simulator, Respiratory Physiotherapy
- Keywords
- cystic fibrosis, hippotherapy simulator, pulmonary functions, sputum expectoration, functional capacity, 6-Minute Walk Test, Postural stability, motor performance, respiratory physiotherapy
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with hippotherapy simulatorOther
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 PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks Receives: Other: Respiratory Physiotherapy |
| Training Group | Experimental | In addition to home-based respiratory physiotherapy, 30 min exercises with the hippotherapy simulator will be done. Receives: Other: Exercise with hippotherapy simulator; Other: Respiratory Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Pulmonary Function Test
Measured: 8 weeks
Forced Expiratory Volume in 1 second (FEV1)
Pulmonary Function Test
Measured: 8 weeks
Tiffeneau ratio (FEV1/FVC)
Pulmonary Function Test
Measured: 8 weeks
Peak Expiratory Flow (PEF)
Pulmonary Function Test
Measured: 8 weeks
Distance covered in six minute walk test
Functional Capacity
Measured: 8 weeks
Postural stability test score in Biodex Balance System SD
Postural Stability
Measured: 8 weeks
Limits of stability test score in Biodex Balance System SD
Postural Stability
Measured: 8 weeks
Secondary outcomes (10)
Biering Sorenson Test
Core Muscles Endurance
Measured: 8 weeks
Lateral Bridge Test
Core Muscles Endurance
Measured: 8 weeks
Trunk Flexion Test
Core Muscles Endurance
Measured: 8 weeks
m. quadriceps strength
Peripheral Muscle Strength
Measured: 8 weeks
Amount of sputum expelled (gr)
Sputum amount
Measured: 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.
Measured: 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.
Measured: 8 weeks
Sit and reach test
Flexibility
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start19 Dec 2021
- Primary completion19 Feb 2024
- Study completion26 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Çınar, Istanbul University - Cerrahpasa
- Investigators
- Betül Çınar, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027503
- Sponsor's protocol ID
- IUCbcinar01
- Status last verified
- May 2024
- First submitted
- 19 Aug 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of the Hippotherapy Simulator Added to Respiratory Physiotherapy in Children and Adolescents with Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05027503
- Acronym / sponsor ID
- IUCbcinar01
- Conditions
- Cystic Fibrosis in Children
- Keywords
- cystic fibrosis, hippotherapy simulator, pulmonary functions, sputum expectoration, functional capacity, 6-Minute Walk Test, Postural stability, motor performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 26 May 2024 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Respiratory PhysiotherapyHome-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks |
| Training Group | Experimental | Other: Exercise with hippotherapy simulator, Other: Respiratory PhysiotherapyIn addition to home-based respiratory physiotherapy, 30 min exercises with the hippotherapy simulator will be done. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with hippotherapy simulator30-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. | Other | Training Group |
| Respiratory PhysiotherapyRespiratory 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 | Control Group, Training Group |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: 8 weeks
Pulmonary Function Test
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 8 weeks
Pulmonary Function Test
Tiffeneau ratio (FEV1/FVC)
Time frame: 8 weeks
Pulmonary Function Test
Peak Expiratory Flow (PEF)
Time frame: 8 weeks
Pulmonary Function Test
Distance covered in six minute walk test
Time frame: 8 weeks
Functional Capacity
Postural stability test score in Biodex Balance System SD
Time frame: 8 weeks
Postural Stability
Limits of stability test score in Biodex Balance System SD
Time frame: 8 weeks
Postural Stability
10 secondary outcomes
Biering Sorenson Test
Time frame: 8 weeks
Lateral Bridge Test
Time frame: 8 weeks
Trunk Flexion Test
Time frame: 8 weeks
m. quadriceps strength
Time frame: 8 weeks
Amount of sputum expelled (gr)
Time frame: 8 weeks
Ease of expectoration
Time frame: 8 weeks
Sense of chest congestion
Time frame: 8 weeks
Sit and reach test
Time frame: 8 weeks
Physical Activity Questionnaire for Children (PAQ-C)
Time frame: 8 weeks
Cystic Fibrosis Questionnaire Revised (CFQ-R)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betül Çınar principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with hippotherapy simulator and Respiratory Physiotherapy in people with Cystic Fibrosis in Children, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.