Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study
- Conditions
- Insulin HypoglycemiaDiabetes Mellitus, Type 1
- Interventions
- Behavioral: "Two sessions per period" - "Five sessions per period"Behavioral: "Five sessions per period" - "Two sessions per period"
- Registration Number
- NCT04089462
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Type 1 Diabetes ≥ 2 year
- Insulin pump ≥ 1 year.
- Use of carbohydrate counting and the insulin pump bolus calculator for all meals
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2. "Two sessions per period" - "Five sessions per period" "Two sessions per period" - "Five sessions per period" - 1. "Five sessions per period" - "Two sessions per period" "Five sessions per period" - "Two sessions per period" -
- Primary Outcome Measures
Name Time Method Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l) The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT) Intention-to-treat analysis (ITT).
- Secondary Outcome Measures
Name Time Method 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 Per protocol analysis (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 Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of \< 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
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 Per protocol analysis and intention-to-treat analysis
Number of severe hypoglycemia events during Study day 1: The day when the first exercise session is performed and registered Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis c) 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). Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
Metabolic expenditure rate for the primary intervention periods Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days). Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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 Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis
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) Per protocol analysis and intention-to-treat analysis
Question about patient preference regarding the two study arms At the end of study. Study day 6 the last interventions period. Per protocol analysis and intention-to-treat analysis
Trial Locations
- Locations (1)
Steno Diabetes Center Copenhagen
🇩🇰Gentofte, Denmark