Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes - A Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)
研究概览
简要总结
According to the Standards of Medical Care in Diabetes by the American Diabetes Association, people with diabetes should aim for 30 minutes of moderate-to-vigorous intensity aerobic exercise at least 5 days a week or a total of 150 minutes per week and doing some type of strength training at least 2 times per week in addition to aerobic activity. However, the effects of different forms and intervals of exercise on glycemic control are not well established. Exercise increases the risk of hypoglycemia both during and several hours after exercise.
There are several strategies to avoid hypoglycemia during exercise. The most common strategy is to reduce insulin and to take carbohydrates before the exercise starts. Short-acting insulin analogs have a duration of approximately four hours, thus reductions need to be planned and done well in advance before the exercise starts. Since different types of exercise (aerobic, strength training or high intensity training) affect blood glucose in different ways and most exercise sessions include a combination of the types, these strategies are often associated with difficulties in obtaining stable blood glucose. The American Diabetes Association guidelines do not explicitly recommend a daily workout routine but outline recommendations for weekly amounts of exercise as there is currently insufficient evidence on the ideal timing, frequency and duration of exercise for preventing hypoglycemia.
Hypothesis: in people with type 1 diabetes, time in hypoglycemia can be reduced if exercise is performed daily over five consecutive days compared to the same total amount of exercise performed at 2 days with at least 2 days interval.
Aim: to evaluate the impact of the same total amount of exercise split into either five consecutive sessions or two sessions with at least 2 days in between on percentage of time spent in hypoglycemia and other glycemic parameters in people with type 1 diabetes.
详细描述
The participants will go through two interventions: Exercise one session per day for five consecutive days and Exercise one session per day for two days within five days. The exercise session will start with anaerobic (push-ups, back-curls, sit-ups, triceps-dips and jumps) exercise followed by aerobic exercise (moderate intensity of running, walking or cycling). Between the two intervention periods, there will be a wash-out period.
Intervention: 'Exercise one session per day for five consecutive days'. Duration per session: Anaerobic: 4 min, Aerobic: 30 min. Sessions per intervention period: Five. Total duration per intervention period: Anaerobic: 20 min. Aerobic: 150 min. Total: 170 min
Intervention:Exercise one session per day for two days within five days. Duration per session: Anaerobe: 10 min, Aerobe: 75 min. Sessions per intervention period: 2. Total duration per intervention period: Anaerob: 20 min Aerobe: 150 min Total: 170 min
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes ≥ 2 year
- •Insulin pump ≥ 1 year.
- •Use of carbohydrate counting and the insulin pump bolus calculator for all meals
排除标准
- •Use of anti-diabetic medicine (other than insulin), per oral or injected corticosteroids or other drugs affecting glucose metabolism during the intervention period or within 30 days prior to study start
- •Known or suspected alcohol or drug abuse
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation
- •Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- •Inability to understand the participants' information and to give informed consent
- •Chronic use or unable to stop acetaminophen (paracetamol) use
- •Allergy to the patch of CGM
- •Hypoglycemia unawareness, quantified by Pedersen-Bjergaard
- •Severe hypoglycemia within the last year
- •Vigorous-intensity exercise for more than 60 minutes on 3 days or more per week
结局指标
主要结局
Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)
时间窗: The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT)
Intention-to-treat analysis (ITT).
次要结局
- Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)(Primary intervention period from 06:00h study day 1 - 06:00h study day 6 PP)
- Percentage of time spent in the alert and clinical hypoglycemic range(The time the participant has recorded start and end of exercise session during study day 1 to study day 6)
- Number of alert and clinical hypoglycemia events(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 study day 6)
- Number of severe hypoglycemia events during(Study day 1: The day when the first exercise session is performed and registered)
- Number of severe hypoglycemia events(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 - study day 6)
- Percentage of time in range (3.9-10 mmol/l)(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Percentage of time in good range (3.9-7.8 mmol/l)(Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6)
- Percentage of time in hyperglycemia (>10 mmol/l)(Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6)
- Percentage of time in hyperglycemia (>10 mmol/l) during all the predefined time blocks. Per protocol analysis and intention-to-treat analysis(Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days))
- Heart rate during exercise sessions(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Mean CGM glucose level du during all the predefined time blocks in the intervention period(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- CGM estimated eA1c during the primary intervention period(The Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days))
- Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Carbohydrate interventions for prevention and treatment of hypoglycemia registered by the participants in the booklet for the primary and total intervention period(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days))
- Change in total daily insulin dose (basal and bolus insulin) of 7 days prior to screening day and during the primary and total intervention period(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).)
- Actigraph wrist wear time during all predefined time blocks(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Metabolic expenditure rate for the primary intervention periods(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).)
- Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days))
- Time in sedentary during predefined time blocks(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Time in light physical activity during predefined time blocks(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Time in moderate physical activity during predefined time blocks(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Time in vigorous physical activity during predefined time blocks(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Number of steps during predefined time blocks(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- R-R intervals during exercise sessions (f)(Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6)
- Sleep latency (min) during the primary and total intervention period(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days))
- Total sleep time (min) during the primary and total intervention period(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days))
- Sleep efficiency (%) during the primary and total intervention period(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days))
- Number of awakening during sleep in the primary and total intervention period(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days))
- Time of awakening during sleep in the primary and total intervention period(Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days))
- Question about patient preference regarding the two study arms(At the end of study. Study day 6 the last interventions period.)