Clinical trial NCT01962259: Active Commuting To Improve Well-being and Health in Everyday Life
Official title: Active Commuting To Improve Well-being and Health in Everyday Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
First posted: 2013-10-14
Enrollment: 188
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals.

Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group


Eligibility criteria: Inclusion Criteria:

* Healthy
* No engagement in habitual structured physical activity
* Body mass index 25-35 kg/m2
* Body fat percentage \>32% for women and \>25% for men
* Maximum oxygen uptake (VO2max) \<40 ml O2/kg/min for women and \<45 ml O2/kg/min for men
* Ethnicity: Caucasian

Exclusion Criteria:

* Chronic use of medicine
* Smoking
* Fasting plasma glucose \> 6,1 mmol/L
* Blood pressure \> 140/90 mm Hg
* Abnormal resting and working ECG
* Parents or siblings with diagnosed type 2 diabetes
* For women: Follicle stimulating hormone (FSH) concentration \> 35 milliunits/ml, pregnancy or planning of pregnancy within the coming year

Primary outcomes:
measure: Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
timeFrame: Change from baseline in peripheral insulin sensitivity at 3 months
measure: Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
timeFrame: Change from baseline in peripheral insulin sensitivity at 6 months
measure: Haemostatic balance
timeFrame: Change from baseline in endogenous thrombin potential at 3 months
measure: Haemostatic balance
timeFrame: Change from baseline in endogenous thrombin potential at 6 months
Secondary outcomes:
measure: Glycaemic control
timeFrame: Baseline, 3 and 6 months
measure: Central insulin sensitivity
timeFrame: Baseline, 3 and 6 months
measure: Maximal oxygen uptake (ml/O2/kg/min)
timeFrame: Baseline, 3 and 6 months
measure: Abdominal fat mass
timeFrame: Baseline, 3 and 6 months
measure: Metabolic syndrome
timeFrame: Baseline, 3 and 6 months
measure: Haemostatic balance II
timeFrame: Baseline, 3 and 6 months
measure: Health related quality of life and other psycho-social outcomes
timeFrame: Baseline, 3 and 6 months
measure: Anthropometry
timeFrame: Baseline, 3 and 6 months
measure: Sleep habits
timeFrame: Baseline, 3 and 6 months
measure: Skeletal muscle biopsy
timeFrame: Baseline, 3 and 6 months
measure: Subcutaneous adipose tissue biopsy
timeFrame: Baseline, 3 and 6 months
Other outcomes:
measure: Exercise compliance
timeFrame: Baseline, 3 and 6 month
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Biomedical Sciences
Study officials:
affiliation: University of Copenhagen, Department of Biomedical Sciences
name: Bente M Stallknecht, MD,PHD,DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kern T, Blond MB, Hansen TH, Rosenkilde M, Quist JS, Gram AS, Ekstrom CT, Hansen T, Stallknecht B. Structured exercise alters the gut microbiota in humans with overweight and obesity-A randomized controlled trial. Int J Obes (Lond). 2020 Jan;44(1):125-135. doi: 10.1038/s41366-019-0440-y. Epub 2019 Aug 29.
citation: Quist JS, Rosenkilde M, Gram AS, Blond MB, Holm-Petersen D, Hjorth MF, Stallknecht B, Sjodin A. Effects of Exercise Domain and Intensity on Sleep in Women and Men with Overweight and Obesity. J Obes. 2019 Apr 7;2019:2189034. doi: 10.1155/2019/2189034. eCollection 2019.
citation: Blond MB, Rosenkilde M, Gram AS, Tindborg M, Christensen AN, Quist JS, Stallknecht BM. How does 6 months of active bike commuting or leisure-time exercise affect insulin sensitivity, cardiorespiratory fitness and intra-abdominal fat? A randomised controlled trial in individuals with overweight and obesity. Br J Sports Med. 2019 Sep;53(18):1183-1192. doi: 10.1136/bjsports-2018-100036. Epub 2019 Mar 16.
citation: Quist JS, Rosenkilde M, Petersen MB, Gram AS, Sjodin A, Stallknecht B. Effects of active commuting and leisure-time exercise on fat loss in women and men with overweight and obesity: a randomized controlled trial. Int J Obes (Lond). 2018 Mar;42(3):469-478. doi: 10.1038/ijo.2017.253. Epub 2017 Oct 10.
citation: Gram AS, Bladbjerg EM, Quist JS, Petersen MB, Rosenkilde M, Stallknecht B. Anti-inflammatory effects of active commuting and leisure time exercise in overweight and obese women and men: A randomized controlled trial. Atherosclerosis. 2017 Oct;265:318-324. doi: 10.1016/j.atherosclerosis.2017.06.923. Epub 2017 Jun 28.