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NCT Number: NCT05027503

Effectiveness of the Hippotherapy Simulator 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.

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Key information

Conditions

Cystic Fibrosis in Children Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: 8 weeks

    Pulmonary Function Test

  2. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 8 weeks

    Pulmonary Function Test

  3. Tiffeneau ratio (FEV1/FVC)

    Time frame: 8 weeks

    Pulmonary Function Test

  4. Peak Expiratory Flow (PEF)

    Time frame: 8 weeks

    Pulmonary Function Test

  5. Distance covered in six minute walk test

    Time frame: 8 weeks

    Functional Capacity

  6. Postural stability test score in Biodex Balance System SD

    Time frame: 8 weeks

    Postural Stability

  7. Limits of stability test score in Biodex Balance System SD

    Time frame: 8 weeks

    Postural Stability

Secondary outcomes

  1. Biering Sorenson Test

    Time frame: 8 weeks

    Core Muscles Endurance

  2. Lateral Bridge Test

    Time frame: 8 weeks

    Core Muscles Endurance

  3. Trunk Flexion Test

    Time frame: 8 weeks

    Core Muscles Endurance

  4. m. quadriceps strength

    Time frame: 8 weeks

    Peripheral Muscle Strength

  5. Amount of sputum expelled (gr)

    Time frame: 8 weeks

    Sputum amount

  6. Ease of expectoration

    Time frame: 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.

  7. Sense of chest congestion

    Time frame: 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.

  8. Sit and reach test

    Time frame: 8 weeks

    Flexibility

  9. Physical Activity Questionnaire for Children (PAQ-C)

    Time frame: 8 weeks

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

  10. Cystic Fibrosis Questionnaire Revised (CFQ-R)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Investigation of the Effectiveness of the Hippotherapy Simulator Added to Respiratory Physiotherapy in Children and Adolescents with Cystic Fibrosis

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2021
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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