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

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Recruiting
CT.gov ID
NCT05027503
Collaborator
(none)
32
1
2
8
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise with hippotherapy simulator
  • Other: Respiratory Physiotherapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effectiveness of the Hippotherapy Simulator Added to Respiratory Physiotherapy in Children and Adolescents With Cystic Fibrosis
Actual Study Start Date :
Dec 19, 2021
Anticipated Primary Completion Date :
Jul 19, 2022
Anticipated Study Completion Date :
Aug 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

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

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.

Experimental: Training Group

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

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Forced Vital Capacity (FVC) [8 weeks]

    Pulmonary Function Test

  2. Forced Expiratory Volume in 1 second (FEV1) [8 weeks]

    Pulmonary Function Test

  3. Tiffeneau ratio (FEV1/FVC) [8 weeks]

    Pulmonary Function Test

  4. Peak Expiratory Flow (PEF) [8 weeks]

    Pulmonary Function Test

  5. Distance covered in six minute walk test [8 weeks]

    Functional Capacity

  6. Amount of sputum expelled (gr) [8 weeks]

    Sputum amount

Secondary Outcome Measures

  1. Postural stability test score in Biodex Balance System SD [8 weeks]

    Postural Stability

  2. Limits of stability test score in Biodex Balance System SD [8 weeks]

    Postural Stability

  3. Sit and reach test [8 weeks]

    Flexibility

  4. m. quadriceps strength [8 weeks]

    Peripheral Muscle Strength

  5. Biering Sorenson Test [8 weeks]

    Core Muscles Endurance

  6. Lateral Bridge Test [8 weeks]

    Core Muscles Endurance

  7. Trunk Flexion Test [8 weeks]

    Core Muscles Endurance

  8. Physical Activity Questionnaire for Children (PAQ-C) [8 weeks]

    Physical Activity Level. As a result of the 9-item questionnaire, 1 means lowest and 5 means highest physical activity level.

  9. Cystic Fibrosis Questionnaire Revised (CFQ-R) [8 weeks]

    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.

  10. Sense of chest congestion [8 weeks]

    Subjective evaluation method questioning "sense of chest congestion" with visual analog scale (0-10 point). A higher score indicates greater sense of chest congestion.

  11. Ease of expectoration [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem Vakif University Istanbul Turkey

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

  • Principal Investigator: Betül Çınar, Istanbul University - Cerrahpaşa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Betül Çınar, Lecturer, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT05027503
Other Study ID Numbers:
  • IUCbcinar01
First Posted:
Aug 30, 2021
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Betül Çınar, Lecturer, Istanbul University-Cerrahpasa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022