Medical and Physiological Benefits of Reduced Sitting

Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Physical Activity; Metabolic Syndrome; Insulin Resistance
• Intervention / Treatment: Behavioral: Reduced sitting

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20521
    • Turku PET Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Reduced sitting; Objectively measured daily inactive time will be reduced by one hour compared to the baseline.	Behavioral: Reduced sitting; Subjects are guided to limit their sitting time during the day for 1 hour/day, by adding light activity with the help of an activity monitor. Subjects are not encouraged to increase their moderate to vigorous physical activity levels.
NO_INTERVENTION: Control; Subjects will be guided to maintain their normal sedentary behaviour and physical activity habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in whole-body insulin sensitivity	M-value during the hyperinsulinemic euglycemic clamp	The change from baseline to 6 months
The change in skeletal muscle insulin-stimulated glucose uptake	Glucose uptake in the femoral muscles will be measured by positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer during hyperinsulinemic euglycemic clamp	The change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
daily sitting hours	Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer	through study completion, an average of 6 months
daily hours spent physically active	Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer	through study completion, an average of 6 months
The change in liver adiposity	Liver fat content will be assessed using magnetic resonance spectroscopy (MRS)	The change from baseline to 6 months
The change in maximal oxygen uptake	Maximal oxygen uptake (VO2peak) will be determined by cycle ergometry with direct respiratory measurements. Exercise intensity will be started at 50 W and the intensity will be increased by 25 W at every two minutes until the criteria used to establish the VO2peak are met. The criteria used to establish the VO2peak are a plateau in VO2 despite of an increase in intensity and a respiratory quotient greater than 1.1. or volitional fatigue.	The change from baseline to 6 months
The change in body fat percentage	Air displacement plethysmography (the Bod Pod system, COSMED, Inc., Concord, CA, USA) will be used to measure body composition (fat mass and fat free mass) with thoracic gas volume being predicted.	The change from baseline to 3 months
The change in body fat percentage	Air displacement plethysmography (the Bod Pod system, COSMED, Inc., Concord, CA, USA) will be used to measure body composition (fat mass and fat free mass) with thoracic gas volume being predicted.	The change from baseline to 6 months
The change in plasma glucose	Plasma glucose content will be measured from fasting venous blood samples using standard assays	The change from baseline to 3 months
The change in plasma glucose	Plasma glucose content will be measured from fasting venous blood samples using standard assays	The change from baseline to 6 months
The change in HbA1c	Glycated hemoglobin will be measured from fasting venous blood samples using standard assays	The change from baseline to 3 months
The change in HbA1c	Glycated hemoglobin will be measured from fasting venous blood samples using standard assays	The change from baseline to 6 months

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: UKK Institute
• Investigators: Study Chair: Juhani Knuuti, Professor, Turku PET Centre, Turku University hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2017
• Primary Completion (ACTUAL): February 14, 2020
• Study Completion (ACTUAL): March 4, 2020

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (ACTUAL): April 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Physical Activity; Metabolic Syndrome; Accelerometry; Insulin Sensitivity; Sedentary Lifestyle; Cardiovascular Risk Factor
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: T91/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD of the main outcome measures will be opened if possible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No