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Completed

NCT Number: NCT04868331

Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

The aims of this pilot study are to determine the metabolic demand and exercise intensity level of E-Fit exercise intervention by evaluating the cardiovascular responses in AIS girls and whether the cardiovascular responses for AIS girls performing E-Fit will behave in the same way as compared to healthy controls. We hypothesise that 1) the metabolic demand and exercise intensity of E-Fit exercise intervention is equivalent to moderate-to-vigorous level; and 2) AIS girls have different cardiovascular responses as compared to healthy controls

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tung Wah College

Hong Kong

About this study

AIS girls and age- and gender-matched healthy controls will perform the E-Fit exercise intervention for two trials and gas exchange parameters including oxygen consumption (VO2) and carbon dioxide production (VCO2) will be taken continuously during the exercise. Comparison of VO2 and VCO2 between AIS and healthy controls when performing E-Fit exercise will be made.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cobb angle greater or equal to 15 degree
  • Cleared for physical activity by doctor

Exclusion criteria

  • Cobb angle greater or equal to 40 degree, or
  • Scoliosis with any known etiology, scoliosis with skeletal dysplasia, know endocrine and connective tissue abnormalities, or
  • Known heart condition or other diseases that could affect the safety of exercise, or
  • Eating disorders or GI malabsorption disorders, or
  • Currently taking medication that affects bone or muscle metabolism

Treatment and study plan

Exercise

Behavioral

Two trials of 7-min High Intensity Interval Training (HIIT) with 12 different exercises. Each exercise lasts for 30 seconds continuously with 10 seconds rest interval.

Primary outcomes

  1. Respiratory gas measurement

    Time frame: Day 1

    Breath-by-breath measurement of cardiorespiratory and gas exchange parameters to analyse oxygen consumption (VO2 in ml/min) and carbon dioxide production (VCO2 in ml/min).

  2. Blood Pressure

    Time frame: Day 1

    Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.

  3. Heart rate

    Time frame: Day 1

    Heart rate (bpm) will be measured using a fingertip oximeter.

  4. Oximetry

    Time frame: Day 1

    Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.

Secondary outcomes

  1. Maturity assessment

    Time frame: Day 1

    Sexual maturity using Tanner Scale and onset of menarche will be measured.

  2. Modified Baecke Questionnaire

    Time frame: Day 1

    Habitual physical activity level will be assessed by self-administered questionnaire.

  3. Physical Activity Rating Questionnaire for Children and Youth (PARCY)

    Time frame: Day 1

    Physical activity level and intensity will be assessed by self-administered questionnaire.

  4. Body height

    Time frame: Day 1

    Body height (cm) will be measured with standard stadiometry techniques.

  5. Sitting height

    Time frame: Day 1

    Sitting height (cm) will be measured with standard stadiometry techniques.

  6. Arm Span

    Time frame: Day 1

    Arm span (cm) will be measured with standard stadiometry techniques.

  7. Body Composition

    Time frame: Day 1

    Percentage body fat (%), body weight (kg), lean muscle mass (kg) will be assessed using Bioelectric Impedance Analysis.

Sponsors and collaborators

Lead sponsor

Tung Wah College

Other

Collaborators

  • Chinese University of Hong Kong

Registry information

Official study title

Evaluation of Cardiovascular Responses in Adolescent Idiopathic Scoliosis (AIS) Girls Performing E-Fit Exercise Intervention: a Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2021
Registry last updated
May 11, 2022

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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