Effect of Tele-exercise on Cardiorespiratory Fitness in Paediatrics

NCT ID: NCT06770660

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-02

Study Completion Date

2027-01-31

Brief Summary

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The goal of this clinical trial is to learn if telemedicine exercise programme can improve the cardiorespiratory fitness (how well your body delivers oxygen to muscles and organs) and insulin resistance in Asian children with low cardiorespiratory fitness levels. The main questions it aims to answers are:

* Does telemedicine exercise programme improve the number of 20-metre laps the participant is able to run?
* Does telemedicine exercise programme improve the insulin sensitivity using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) formula?

Researchers will compare the telemedicine exercise programme to current active lifestyle programme (e.g., daily step count monitoring) to see if telemedicine exercise programme is more effective in improving cardiorespiratory fitness.

Participants will:

* participate in weekly telemedicine exercise programme or adhere to current active lifestyle recommendations through daily step count reporting for 10 weeks
* visit the clinic for pre- and post-programme cardiorespiratory fitness assessments and blood taking

Detailed Description

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This study is to investigate the effectiveness of delivering exercise intervention programme to improve cardiorespiratory fitness through telemedicine for paediatric patients with low cardiorespiratory fitness levels. Conventionally, exercise programme for these patients are conducted within hospital premises. However, some challenges may deter patients from enrolling into these programmes, such as long travelling distance, lack of available caregiver and unsuitable timings. Understanding the impact of a shorter-term programme (i.e., 10-week programme) on cardiorespiratory fitness and glucose metabolism also allows us to customise programmes of appropriate length to deliver the require health impact instead of subjecting all patients to a lengthy programme. Therefore, evaluating the effectiveness of telemedicine-based exercise programme will enable us to fine-tune our programme and provide an alternative mode of exercise intervention so as to cater for a wider range of paediatric patients.

Conditions

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Cardiorespiratory Fitness Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Telemedicine

Participants who receive 10-week telemedicine-based exercise programme and physical activity education.

Group Type EXPERIMENTAL

Telemedicine

Intervention Type BEHAVIORAL

A 10-week telemedicine-based exercise programme consisting of 90-minute sessions conducted weekly via a video conferencing platform.

All participants will also be educated on physical activity recommendations, including achieving a minimum of 12,000 steps daily, and required to perform weekly check-in for number of daily steps via online survey form.

Lifestyle

Participants who receive physical activity education only.

Group Type PLACEBO_COMPARATOR

Lifestyle

Intervention Type BEHAVIORAL

All participants will be educated on physical activity recommendations, including achieving a minimum of 12,000 steps daily, and required to perform weekly check-in for number of daily steps via online survey form.

Interventions

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Telemedicine

A 10-week telemedicine-based exercise programme consisting of 90-minute sessions conducted weekly via a video conferencing platform.

All participants will also be educated on physical activity recommendations, including achieving a minimum of 12,000 steps daily, and required to perform weekly check-in for number of daily steps via online survey form.

Intervention Type BEHAVIORAL

Lifestyle

All participants will be educated on physical activity recommendations, including achieving a minimum of 12,000 steps daily, and required to perform weekly check-in for number of daily steps via online survey form.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 12 to 17 years (secondary school students)
* able to participate in school physical education lessons

Exclusion Criteria

* less than 12 years or older than 17 years (non-secondary school students)
* has medical or musculoskeletal condition(s) preventing participation in school physical education lessons or exercise
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Benny Loo Kai Guo

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benny Loo

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Nabil Abdul Rahim

Role: CONTACT

+65 63947254

Benny Loo

Role: CONTACT

+65 63948488

Facility Contacts

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Nabil Abdul Rahim

Role: primary

+65 63947254

Nabil Abdul Rahim

Role: primary

+65 63947254

References

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Reference Type BACKGROUND
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Berman LJ, Weigensberg MJ, Spruijt-Metz D. Physical activity is related to insulin sensitivity in children and adolescents, independent of adiposity: a review of the literature. Diabetes Metab Res Rev. 2012 Jul;28(5):395-408. doi: 10.1002/dmrr.2292. Epub 2012 Mar 2.

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Schmitz KH, Jacobs DR Jr, Hong CP, Steinberger J, Moran A, Sinaiko AR. Association of physical activity with insulin sensitivity in children. Int J Obes Relat Metab Disord. 2002 Oct;26(10):1310-6. doi: 10.1038/sj.ijo.0802137.

Reference Type BACKGROUND
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Ruiz JR, Cavero-Redondo I, Ortega FB, Welk GJ, Andersen LB, Martinez-Vizcaino V. Cardiorespiratory fitness cut points to avoid cardiovascular disease risk in children and adolescents; what level of fitness should raise a red flag? A systematic review and meta-analysis. Br J Sports Med. 2016 Dec;50(23):1451-1458. doi: 10.1136/bjsports-2015-095903. Epub 2016 Sep 26.

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Wong PC, Chia MY, Tsou IY, Wansaicheong GK, Tan B, Wang JC, Tan J, Kim CG, Boh G, Lim D. Effects of a 12-week exercise training programme on aerobic fitness, body composition, blood lipids and C-reactive protein in adolescents with obesity. Ann Acad Med Singap. 2008 Apr;37(4):286-93.

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Santos R, Mota J, Okely AD, Pratt M, Moreira C, Coelho-e-Silva MJ, Vale S, Sardinha LB. The independent associations of sedentary behaviour and physical activity on cardiorespiratory fitness. Br J Sports Med. 2014 Oct;48(20):1508-12. doi: 10.1136/bjsports-2012-091610. Epub 2013 Feb 14.

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Reference Type BACKGROUND
PMID: 34835945 (View on PubMed)

Takken T, Bongers BC, van Brussel M, Haapala EA, Hulzebos EHJ. Cardiopulmonary Exercise Testing in Pediatrics. Ann Am Thorac Soc. 2017 Jul;14(Supplement_1):S123-S128. doi: 10.1513/AnnalsATS.201611-912FR.

Reference Type BACKGROUND
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Tomkinson GR, Lang JJ, Tremblay MS, Dale M, LeBlanc AG, Belanger K, Ortega FB, Leger L. International normative 20 m shuttle run values from 1 142 026 children and youth representing 50 countries. Br J Sports Med. 2017 Nov;51(21):1545-1554. doi: 10.1136/bjsports-2016-095987. Epub 2016 May 20.

Reference Type BACKGROUND
PMID: 27208067 (View on PubMed)

Tomkinson GR, Lang JJ, Blanchard J, Leger LA, Tremblay MS. The 20-m Shuttle Run: Assessment and Interpretation of Data in Relation to Youth Aerobic Fitness and Health. Pediatr Exerc Sci. 2019 May 1;31(2):152-163. doi: 10.1123/pes.2018-0179. Epub 2019 Mar 18.

Reference Type BACKGROUND
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Hui SS, Zhang R, Suzuki K, Naito H, Balasekaran G, Song JK, Park SY, Liou YM, Lu D, Poh BK, Kijboonchoo K, Thasanasuwan W. Physical activity and health-related fitness in Asian adolescents: The Asia-fit study. J Sports Sci. 2020 Feb;38(3):273-279. doi: 10.1080/02640414.2019.1695334. Epub 2019 Nov 27.

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Hogstrom G, Nordstrom A, Nordstrom P. High aerobic fitness in late adolescence is associated with a reduced risk of myocardial infarction later in life: a nationwide cohort study in men. Eur Heart J. 2014 Nov 21;35(44):3133-40. doi: 10.1093/eurheartj/eht527. Epub 2014 Jan 7.

Reference Type BACKGROUND
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Ruiz JR, Castro-Pinero J, Artero EG, Ortega FB, Sjostrom M, Suni J, Castillo MJ. Predictive validity of health-related fitness in youth: a systematic review. Br J Sports Med. 2009 Dec;43(12):909-23. doi: 10.1136/bjsm.2008.056499. Epub 2009 Jan 21.

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Ortega FB, Ruiz JR, Castillo MJ, Sjostrom M. Physical fitness in childhood and adolescence: a powerful marker of health. Int J Obes (Lond). 2008 Jan;32(1):1-11. doi: 10.1038/sj.ijo.0803774. Epub 2007 Dec 4.

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Reference Type BACKGROUND
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Other Identifiers

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02/FY2024/P2/18-A140

Identifier Type: -

Identifier Source: org_study_id

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