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NCT Number: NCT03069625

Sit-to-stand Test in Cystic Fibrosis Children and Adolescents

Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment.

Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents.

The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET.

The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Côte de Nacre, Caen, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cystic Fibrosis
  • Exacerbation-free last month before inclusion

Exclusion criteria

  • Cardiovascular, neurological or musculoskeletal contra-indications to exercise testing
  • Other respiratory disease (kyphoscoliosis, asthma ...)
  • Exacerbation
  • Unability to carry out field tests

Treatment and study plan

Sit-to-stand test

Behavioral

CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.

6-Minute Walk Test

Behavioral

CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.

Primary outcomes

  1. Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance

    Time frame: This outcome will be measured after both tests realization up to 15 minutes.

    Comparison between the results of these two submaximal exercise tests

Secondary outcomes

  1. Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP)

    Time frame: MIP will be measured after inclusion in the hour before field tests realization.

    MIP will be assessed using a microRPM Puma manometer.

  2. Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP)

    Time frame: MEP will be measured after inclusion in the hour before field tests realization.

    MEP will be assessed using a MicroRPM Puma manometer.

  3. Correlation between number of repetitions (STS Test) and health-related quality of life

    Time frame: HRQoL testing will be carried out after inclusion in the hour before field tests realization.

    HRQoL will be measured by the Cystic Fibrosis Questionnaire

  4. Correlation between number of repetitions (STS Test) and quadriceps strength.

    Time frame: Quadriceps strength will be assessed after inclusion in the hour before field tests realization.

    Quadriceps strength will be assessed by handheld dynamometry using a MicroFet II dynamometer.

  5. Correlation between number of repetitions (STS Test) and forced vital capacity (FVC)

    Time frame: Spirometric test will be carried out before field tests realization.

    FVC will be assessed with non invasive spirometry.

  6. Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1)

    Time frame: Spirometric test will be carried out in the last 3 months before field tests realization.

    FEV1 will be assessed with non invasive spirometry.

  7. Correlation between number of repetitions (STS Test) and number of exacerbations / year.

    Time frame: Number of exacerbations / year will assess the number of exacerbations in the last year before inclusion and will be assessed during the initial survey in the hour before field test realization.

  8. Differences in dyspnea and muscular fatigue.

    Time frame: These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.

    These outcomes will be assessed using Modified Borg Scale (0-10 points)

  9. Differences in Heart Rate.

    Time frame: These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.

    These outcomes will be assessed using pulse oximetry.

  10. Differences in Respiratory Rate.

    Time frame: These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes

    These outcomes will be assessed using pulse oximetry.

  11. Differences in Oxygen Saturation.

    Time frame: These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.

    These outcomes will be assessed using pulse oximetry.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Official study title

Sit-to-stand Test Use in Children and Adolescents With Cystic Fibrosis : Correlations With 6-Minute Walking Test, Quadriceps and Respiratory Muscle Strength and Health Related Quality of Life

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Sep 3, 2019

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

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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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