Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study
Condition: Diabetes Mellitus, Type 1; Insulin Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

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
    

Intervention name(s): "Five sessions per period" - "Two sessions per period"; "Two sessions per period" - "Five sessions per period"
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Period 1: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)
Period 2: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session); Period 1: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)
Period 2: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open-labelled randomized controlled crossover study will be performed. The participants will go through the following elements:
Screening day
Run-in period
Intervention period
Wash-out period
Intervention period
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Insulin pump; Diabetes Mellitus, Type 1; Guidelines