NCT06770660

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2025Jan 2027

First Submitted

Initial submission to the registry

January 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 2, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

September 4, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

January 7, 2025

Last Update Submit

August 27, 2025

Conditions

Keywords

paediatriccardiorespiratory fitnesstelemedicineinsulin resistance

Outcome Measures

Primary Outcomes (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

    At the end of 10-week programme

Secondary Outcomes (1)

  • Insulin resistance

    At the end of the 10-week programme

Study Arms (2)

Telemedicine

EXPERIMENTAL

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

Behavioral: Telemedicine

Lifestyle

PLACEBO COMPARATOR

Participants who receive physical activity education only.

Behavioral: Lifestyle

Interventions

TelemedicineBEHAVIORAL

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.

Telemedicine
LifestyleBEHAVIORAL

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.

Lifestyle

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KK Women's and Children's Hospital

Singapore, Singapore

NOT YET RECRUITING

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

Related Publications (16)

  • 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.

    PMID: 21152018BACKGROUND
  • 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.

    PMID: 24298011BACKGROUND
  • 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.

    PMID: 22389103BACKGROUND
  • 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.

    PMID: 12355326BACKGROUND
  • 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.

    PMID: 27670254BACKGROUND
  • 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.

    PMID: 18461212BACKGROUND
  • 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.

    PMID: 23410883BACKGROUND
  • 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.

    PMID: 34835945BACKGROUND
  • 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.

    PMID: 28398090BACKGROUND
  • 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.

    PMID: 27208067BACKGROUND
  • 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.

    PMID: 30885058BACKGROUND
  • 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.

    PMID: 31774367BACKGROUND
  • 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.

    PMID: 24398666BACKGROUND
  • 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.

    PMID: 19158130BACKGROUND
  • 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.

    PMID: 18043605BACKGROUND
  • Raghuveer G, Hartz J, Lubans DR, Takken T, Wiltz JL, Mietus-Snyder M, Perak AM, Baker-Smith C, Pietris N, Edwards NM; American Heart Association Young Hearts Athero, Hypertension and Obesity in the Young Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young. Cardiorespiratory Fitness in Youth: An Important Marker of Health: A Scientific Statement From the American Heart Association. Circulation. 2020 Aug 18;142(7):e101-e118. doi: 10.1161/CIR.0000000000000866. Epub 2020 Jul 20.

    PMID: 32686505BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Benny Loo

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 13, 2025

Study Start

May 2, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

September 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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.

Locations