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Active Commuting To Improve Well-being and Health in Everyday Life

Active Commuting To Improve Well-being and Health in Everyday Life

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01962259
Acronym
GO-ACTIWE
Enrollment
188
Registered
2013-10-14
Start date
2013-11-30
Completion date
2017-07-31
Last updated
2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

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

Interventions

BEHAVIORALPhysical activity

Sponsors

Copenhagen University Hospital, Denmark
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Haemostatic balanceChange from baseline in endogenous thrombin potential at 3 monthsBlood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)Change from baseline in peripheral insulin sensitivity at 3 monthsMeasured using the hyper-insulinemic euglycaemic clamp

Secondary

MeasureTime frameDescription
Central insulin sensitivityBaseline, 3 and 6 monthsFasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Maximal oxygen uptake (ml/O2/kg/min)Baseline, 3 and 6 monthsMeasured using indirect calorimetry and an incremental bicycle protocol
Abdominal fat massBaseline, 3 and 6 monthsVisceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
Metabolic syndromeBaseline, 3 and 6 monthsAs measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Haemostatic balance IIBaseline, 3 and 6 months1: Coagulation: Fibrinogen, Tissue factor(TF), prothrombin fragment 1+2. 2: Fibrinolysis: Tissue type plasminogen activator(tPA:AG), Plasminogen activator inhibitor type 1(PAI-1:AG). 3: Endothelial cell function: von Willebrand factor(vWF), Tissue factor pathway inhibitor (TFPI). 4: Inflammation: C-Reactive protein.
AnthropometryBaseline, 3 and 6 monthsMeasured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Sleep habitsBaseline, 3 and 6 monthsSleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)
Skeletal muscle biopsyBaseline, 3 and 6 monthsBiochemical, proteomics, metabolomics, genomics and morphological analyses
Subcutaneous adipose tissue biopsyBaseline, 3 and 6 monthsBiochemical, proteomics, metabolomics, genomics and morphological analyses
Health related quality of life and other psycho-social outcomesBaseline, 3 and 6 monthsMeasured using questionaries (SF-36), semi-structured interviews and observations
Glycaemic controlBaseline, 3 and 6 monthsFasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test

Other

MeasureTime frameDescription
Exercise complianceBaseline, 3 and 6 monthAdherence to the exercise protocol as measured using heart rate and global positioning system monitors will be assessed and individually adjusted continuously over the course of the exercise intervention

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026