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AzTrials

Cardiorespiratory FitnessNCT06770660

Effect of Tele-exercise on Cardiorespiratory Fitness in Paediatrics

A study testing Telemedicine and Lifestyle in people with Cardiorespiratory Fitness and Insulin Resistance, run by KK Women's and Children's Hospital at 2 sites in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Cardiorespiratory Fitness, Insulin Resistance
What is being tested?
Telemedicine and Lifestyle
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
2 sitesSingapore
Study dates
2 May 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • less than 12 years or 18 years and older (non-secondary school students)
  • has medical or musculoskeletal condition(s) preventing participation in school physical education lessons or exercise

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nabil Abdul Rahim contact

+65 63947254

nabil.syahir.ar@kkh.com.sg

Benny Loo contact

+65 63948488

benny.loo.k.g@singhealth.com.sg

Singapore2 sites, 2 recruiting

  • KK Women's and Children's Hospital

    Singapore

    Nabil Abdul Rahim, +65 63947254, nabil.syahir.ar@kkh.com.sg

    Benny Loo

    Not yet recruiting

  • KK Women's and Children's Hospital

    Singapore

    Nabil Abdul Rahim, +65 63947254, nabil.syahir.ar@kkh.com.sg

    Recruiting

Other trials in Singapore

About this study

Official title: Evaluating the Effectiveness of Telemedicine-based Exercise Programme in Improving Cardiorespiratory Fitness in Asian Paediatric Population: a Randomised Controlled Trial

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?
Read more

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
Read the detailed description

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.

Being tested
Telemedicine, Lifestyle
Keywords
paediatric, cardiorespiratory fitness, telemedicine, insulin resistance
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemedicineBehavioural

    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.

  • LifestyleBehavioural

    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.

Study groups in NCT06770660
Study groupRoleWhat they receive
TelemedicineExperimentalParticipants who receive 10-week telemedicine-based exercise programme and physical activity education.
Receives: Behavioral: Telemedicine
LifestylePlacebo comparatorParticipants who receive physical activity education only.
Receives: Behavioral: Lifestyle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiorespiratory fitness assessment

    Cardiorespiratory fitness (CRF) is defined by the number of completed laps in Progressive Aerobic Cardiovascular Endurance Run (PACER) test, corresponding to the respective CRF levels for gender

    Measured: At the end of 10-week programme

Secondary outcomes (1)

  1. Insulin resistance

    Insulin sensitivity is defined by the HOMA-IR formula [(fasting insulin in µU/ml) x (fasting glucose in mmol/L) / 22.5]; normal is < 2.5

    Measured: At the end of the 10-week programme

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start2 May 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06770660
Sponsor's protocol ID
02/FY2024/P2/18-A140
Status last verified
Aug 2026
First submitted
7 Jan 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data generated and/or analysed during this study are not publicly available due to institutional policy on data confidentiality but are available from the corresponding author on reasonable request.

Publications

  • Hall LM, Moran CN, Milne GR, Wilson J, MacFarlane NG, Forouhi NG, Hariharan N, Salt IP, Sattar N, Gill JM. Fat oxidation, fitness and skeletal muscle expression of oxidative/lipid metabolism genes in South Asians: implications for insulin resistance? PLoS One. 2010 Dec 1;5(12):e14197. doi: 10.1371/journal.pone.0014197.

    PubMed 21152018

  • Fedewa MV, Gist NH, Evans EM, Dishman RK. Exercise and insulin resistance in youth: a meta-analysis. Pediatrics. 2014 Jan;133(1):e163-74. doi: 10.1542/peds.2013-2718. Epub 2013 Dec 2.

    PubMed 24298011

  • 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.

    PubMed 22389103

  • 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.

    PubMed 12355326

  • 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.

    PubMed 27670254

  • 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.

    PubMed 18461212

  • 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.

    PubMed 23410883

  • Calcaterra V, Verduci E, Vandoni M, Rossi V, Di Profio E, Carnevale Pellino V, Tranfaglia V, Pascuzzi MC, Borsani B, Bosetti A, Zuccotti G. Telehealth: A Useful Tool for the Management of Nutrition and Exercise Programs in Pediatric Obesity in the COVID-19 Era. Nutrients. 2021 Oct 20;13(11):3689. doi: 10.3390/nu13113689.

    PubMed 34835945

  • 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.

    PubMed 28398090

  • 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.

    PubMed 27208067

  • 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.

    PubMed 30885058

  • 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.

    PubMed 31774367

  • 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.

    PubMed 24398666

  • 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.

    PubMed 19158130

  • 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.

    PubMed 18043605

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine and Lifestyle in people with Cardiorespiratory Fitness and Insulin Resistance, run by KK Women's and Children's Hospital at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nabil Abdul Rahim (+65 63947254, nabil.syahir.ar@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiorespiratory fitness assessment (time frame: At the end of 10-week programme). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06770660, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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