Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

Sponsor

Tung Wah College (Other)

Overall Status

Completed

CT.gov ID

NCT04868331

Collaborator

Chinese University of Hong Kong (Other)

Enrollment

Location

Arms

9.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adolescent Idiopathic Scoliosis	Behavioral: Exercise	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 18, 2021

Actual Primary Completion Date :

Mar 12, 2022

Actual Study Completion Date :

Mar 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIS girls Girls between the ages of 10-16 will be recruited if they have a diagnosis of AIS.	Behavioral: Exercise 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.
Active Comparator: Healthy Controls Healthy adolescent girls matched in age and puberty maturity without spinal deformity	Behavioral: Exercise 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.

Arm

Intervention/Treatment

Experimental: AIS girls

Girls between the ages of 10-16 will be recruited if they have a diagnosis of AIS.

Behavioral: Exercise

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.

Active Comparator: Healthy Controls

Healthy adolescent girls matched in age and puberty maturity without spinal deformity

Behavioral: Exercise

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.

Outcome Measures

Primary Outcome Measures

Respiratory gas measurement [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).
Blood Pressure [Day 1]
Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.
Heart rate [Day 1]
Heart rate (bpm) will be measured using a fingertip oximeter.
Oximetry [Day 1]
Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.

Secondary Outcome Measures

Maturity assessment [Day 1]
Sexual maturity using Tanner Scale and onset of menarche will be measured.
Modified Baecke Questionnaire [Day 1]
Habitual physical activity level will be assessed by self-administered questionnaire.
Physical Activity Rating Questionnaire for Children and Youth (PARCY) [Day 1]
Physical activity level and intensity will be assessed by self-administered questionnaire.
Body height [Day 1]
Body height (cm) will be measured with standard stadiometry techniques.
Sitting height [Day 1]
Sitting height (cm) will be measured with standard stadiometry techniques.
Arm Span [Day 1]
Arm span (cm) will be measured with standard stadiometry techniques.
Body Composition [Day 1]
Percentage body fat (%), body weight (kg), lean muscle mass (kg) will be assessed using Bioelectric Impedance Analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 16 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tung Wah College	Hong Kong		Hong Kong

Sponsors and Collaborators

Tung Wah College
Chinese University of Hong Kong

Investigators

Principal Investigator: Rufina Lau, MSc, Tung Wah College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rufina Lau, Senior Lecturer, Tung Wah College

ClinicalTrials.gov Identifier:

NCT04868331

Other Study ID Numbers:

2019-02-52-SRG190201

First Posted:

Apr 30, 2021

Last Update Posted:

May 11, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Study Results

No Results Posted as of May 11, 2022