Exercise Intensity, Glycemic Control and Abdominal Fat in People With Type 2 Diabetes: A Pilot Study
|ClinicalTrials.gov Identifier: NCT01144078|
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : January 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Traditional Intensity Exercise Behavioral: High Intensity Interval Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: High Intensity Interval Exercise
This arms receives the High Intensity Interval Exercise intervention
Behavioral: High Intensity Interval Exercise
The High Intensity Interval Exercise intervention will replicate all aspects of the Traditional Intensity Exercise with the exception of exercise intensity. The High Intensity Interval Exercise protocol will involve alternating between 1-minute intervals at 100% workload obtained at VO2peak followed by 3-minute recovery intervals at 20% of workload obtained at VO2peak (average = 40% ). As many complete intervals as possible will be completed during a training session (e.g., 7 intervals can be completed in a 30 min period (7 x 4 min = 28 min), with the remaining time spent at 40% peak workload to ensure a similar work output as the Traditional Intensity Exercise.
Experimental: Traditional Intensity Exercise
This arms receives the Traditional Intensity Exercise intervention
Behavioral: Traditional Intensity Exercise
The exercise intensity will be set at a workload corresponding to 40% of the workload obtained at VO2peak during the baseline progressive maximal exercise tests. Based on the anticipated fitness of the participants this should to an intensity of about 3.5 METs, which is similar to walking at a moderate pace.
- Feasibility of these exercise interventions in people with type 2 diabetes [ Time Frame: The feasibility of recruiting will be assessed over the 12-month recruitment phase. Adherence will be measured throughout the 14-week interventions. Retention will consider those who participate in the assessments before and after the intervention. ]
- Intra-abdominal fat [ Time Frame: During the week before and the week after the 14 week exercise interventions ]Intra-abdominal fat will be estimated by previously validated technique of combining DXA and anthropometric measurements (Bertin 2000)
- Glycated hemoglobin (A1c) [ Time Frame: During the week before and the week after the 14 week exercise interventions ]
- Glucose [ Time Frame: Before and after individual exercise sessions ]Throughout the intervention period, we will take regular capillary blood glucose and lactate measures with a OneTouch® Ultra (LifeScan; Milpitas, CA, USA) portable glucose analyzer and a Accusport® (Boehringer Mannheim, Castle Hill, Australia) portable lactate analyzer. Samples will be taken 5 minutes before and 5 minutes after the exercise bout.
- Plasma lipids and lipoproteins [ Time Frame: During the week before and the week after the 14 week exercise interventions ]
- HDL cholesterol
- LDL cholesterol
- Total cholesterol
- Daily steps [ Time Frame: During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions ]Daily steps will be measured with a Yamax SW-200Digiwalker Pedometer.
- Dietary intake [ Time Frame: During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions ]Dietary intake will be estimated by a standard 3-day food record (2 weekdays and 1 weekend).
- Anthropometrics [ Time Frame: During the week before and the week after the 14 week exercise interventions ]Anthropometrics will include: height, weight, waist circumference and hip circumference.
- Blood pressure [ Time Frame: During the week before and the week after the 14 week exercise interventions ]
- Fitness [ Time Frame: During the week before and the week after the 14 week exercise interventions ]A graded maximal cycle ergometer test will be conducted on a cycle ergometer. The test will begin at a pedal rate of 60-65 rpm and a resistance of 0 kp. Pedaling rate will remain constant but resistance will increase by 0.5 kp every 2 min until exhaustion. Respiratory gases will be analyzed throughout (TrueMax; ParvoMedics, Salt Lake City, UT, USA). Heart rate was continuously monitored with a polar heart rate monitor (Polar Electro, NY, USA).
- Exercise Self-efficacy [ Time Frame: During week 1, week 8 and week 14 of the exercise interventions ]A series of questions will be used to obtain preliminary information on the acceptability of the exercise protocols to the participants. The questions will include rating of perceived exertion (Borg Scale), as well as several indications of the participants confidence in being able to complete such exercise on a regular basis, including coping, task and scheduling self-efficacy. Other questions that related to fatigue will also be asked.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144078
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2H9|
|Principal Investigator:||Normand G. Boulé, PhD||University of Alberta|