Clinical trial NCT03101228: Medical and Physiological Benefits of Reduced Sitting
Official title: Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Physical Activity
Insulin Resistance
Cardiovascular Diseases
Keywords: Physical Activity
Metabolic Syndrome
Insulin Sensitivity
Cardiovascular Risk Factor
Sedentary Lifestyle
Accelerometry
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: UKK Institute
First posted: 2017-04-05
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel-group randomised controlled trial
Primary purpose: PREVENTION

Brief summary: The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.


Eligibility criteria: Inclusion Criteria:

* Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)
* Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)
* BMI 25-40
* Blood pressure \< 160/100 mmHg
* Fasting plasma glucose \< 7.0 mmol/l
* Fulfills the criteria of the metabolic syndrome according to Alberti et al 2009

Exclusion Criteria:

* History of a cardiac event
* Insulin or medically treated diabetes
* Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
* Presence of ferromagnetic objects that would make MR imaging contraindicated
* Abundant use of alcohol
* Use of narcotics
* Smoking of tobacco or consuming snuff tobacco
* Diagnosed depressive or bipolar disorder
* Previous PET imaging or considerable exposure to radiation

Primary outcomes:
measure: The change in whole-body insulin sensitivity
timeFrame: The change from baseline to 6 months
measure: The change in skeletal muscle insulin-stimulated glucose uptake
timeFrame: The change from baseline to 6 months
Secondary outcomes:
measure: daily sitting hours
timeFrame: through study completion, an average of 6 months
measure: daily hours spent physically active
timeFrame: through study completion, an average of 6 months
measure: The change in liver adiposity
timeFrame: The change from baseline to 6 months
measure: The change in maximal oxygen uptake
timeFrame: The change from baseline to 6 months
measure: The change in body fat percentage
timeFrame: The change from baseline to 3 months
measure: The change in body fat percentage
timeFrame: The change from baseline to 6 months
measure: The change in plasma glucose
timeFrame: The change from baseline to 3 months
measure: The change in plasma glucose
timeFrame: The change from baseline to 6 months
measure: The change in HbA1c
timeFrame: The change from baseline to 3 months
measure: The change in HbA1c
timeFrame: The change from baseline to 6 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET Centre
Study officials:
affiliation: Turku PET Centre, Turku University Hospital
name: Juhani Knuuti, Professor
role: STUDY_CHAIR
References:
citation: Norha J, Hautala AJ, Sjoros T, Laine S, Garthwaite T, Knuuti J, Loyttyniemi E, Vaha-Ypya H, Sievanen H, Vasankari T, Heinonen IHA. Standing time and daily proportion of sedentary time are associated with pain-related disability in a one month accelerometer measurement in adults with overweight or obesity. Scand J Pain. 2021 Sep 27;22(2):317-324. doi: 10.1515/sjpain-2021-0108. Print 2022 Apr 26.
citation: Sjoros T, Vaha-Ypya H, Laine S, Garthwaite T, Lahesmaa M, Laurila SM, Latva-Rasku A, Savolainen A, Miikkulainen A, Loyttyniemi E, Sievanen H, Kalliokoski KK, Knuuti J, Vasankari T, Heinonen IHA. Both sedentary time and physical activity are associated with cardiometabolic health in overweight adults in a 1 month accelerometer measurement. Sci Rep. 2020 Nov 25;10(1):20578. doi: 10.1038/s41598-020-77637-3.