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临床试验/NCT04006938
NCT04006938Unknown不适用

The Effect of Continuous Versus Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes - A Crossover Randomized Control Trial

Springfield College0 个研究点目标入组 30 人开始时间: 2019年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
Fasting blood sugar level

研究概览

简要总结

The purpose of this study will be to evaluate and compare the effect of a single 30-minute bout of moderate intensity aerobic exercise to the effect of three 10-minute pre-prandial bouts of energy-matched and volume-matched aerobic exercise on 2-hr post prandial and fasting blood sugar levels, in a sample of type 2 diabetes patients, aged 30-65 years, living in Barbados

Research Hypotheses:

The three bouts of pre-prandial moderate intensity aerobic exercise will result in lower post prandial blood sugar levels when compared to the single bout of moderate intensity aerobic exercise.

The three bouts of pre-prandial moderate intensity aerobic exercise will result in lower fasting blood sugar levels on the morning following the exercise intervention when compared to the single bout of moderate intensity aerobic exercise

详细描述

With the background that there is increasing evidence that breaking up sedentary time with physical activity may be potentially associated with improved blood glucose levels (Francois et al., (2014) & van Dijk et al., (2013), this study aims to investigate and compare the effect of a single 30-minute bout of moderate intensity aerobic exercise to the effect of three 10-minute pre-prandial bouts of energy-matched and volume-matched aerobic exercise on 2-hr post prandial and fasting blood sugar levels in a sample of type 2 diabetes patients.

Different from previous studies, this research seeks to evaluate these effects in a Black Caribbean population, in a type 2 diabetes population on medication including insulin and also seeks to evaluate if either exercise regimen is indeed palatable to the target population by evaluating treatment acceptability.

The proposed study will be a crossover randomized controlled study. There will be two intervention groups - a single 30-minute bout of moderate intensity aerobic exercise before breakfast and three (3) 10-minute bouts of moderate intensity aerobic activity before breakfast, lunch and dinner. The primary outcome measure will be 2-hr post prandial blood sugar levels and fasting blood sugar levels on the day following the intervention. Neither subject nor investigator will be blinded to the intervention.

Subjects will include patients with a documented diagnosis of type 2 diabetes, that is a documented HbA1C ≥ 6.5%. Baseline data will include body mass and body composition and will be measured using the bioelectrical impedance technique (Tanita scale). Waist circumference will be assessed using a Gulick tape measure. Baseline sedentary behaviour and physical activity level will be assessed using the validated International Physical Activity Questionnaire.

All recruited subjects will be asked to complete two exercise interventions separated by a one-week washout period: 1) a single 30-minute bout of moderate intensity aerobic exercise before breakfast and 2) three (3) 10-minute bouts of moderate intensity aerobic activity before breakfast, lunch and dinner. Each subject will be randomized to one of two treatment sequences: single bout followed by multiple bouts (S-M) or multiple bouts followed by single bout (M-S). The randomization will be done using online statistical computing web programming (www.randomization.com) to generate a randomization schedule with balanced permutations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 30-65 years
  • Documented diagnosis of type 2 diabetes (HbA1C ≥ 6.5%)

排除标准

  • Subjects currently managed on prandial insulin
  • Subjects who have recently started insulin (within the previous month)
  • Subjects with a history of frequent hypoglycemic episodes within the previous 2 weeks,
  • Pregnancy
  • Subjects with a history of cerebrovascular accident, myocardial infarction, chronic kidney disease, autonomic and peripheral neuropathy
  • Subjects with contraindications to exercise according to ACSM 2018 guidelines

研究组 & 干预措施

Single Bout ('S') - 30 minutes of moderate intensity cycling

Experimental

Subjects will perform a single 30-minute bout of moderate intensity cycling before breakfast

干预措施: Single Bout ('S') (Behavioral)

Multiple Bout ('M')

Experimental

Subjects will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner

干预措施: Multiple Bout ('M') (Behavioral)

结局指标

主要结局

Fasting blood sugar level

时间窗: single point measurement taken after 8 hours of fasting

blood sugar level after 8 hours of fasting performed on day following exercise intervention

2 hour post prandial blood glucose level after dinner

时间窗: single point measurement taken 2 hours after dinner consumption

blood glucose level 2 hours after dinner consumption

2 hour post prandial blood glucose level after breakfast

时间窗: single point measurement taken 2 hours after breakfast consumption

blood glucose level 2 hours after breakfast consumption

2 hour post prandial blood glucose level after lunch

时间窗: single point measurement taken 2 hours after lunch consumption

blood glucose level 2 hours after lunch consumption

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristyn Kirton

Principal Investigator

Springfield College

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