Effect of Tele-exercise on Cardiorespiratory Fitness in Paediatrics

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Cardiorespiratory fitness assessment [Срок оценки: At the end of 10-week programme]

Вторичные конечные точки (1)

• Insulin resistance [Срок оценки: At the end of the 10-week programme]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Сингапур · 2 центра

• KK Women's and Children's Hospital — Singapore
• KK Women's and Children's Hospital — Singapore

Публикации

• 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 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34835945

Идентификаторы

NCT: NCT06770660 · 02/FY2024/P2/18-A140

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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