Health TrialsbyHealthPanel

Sitting Interruption and Whole-body Cardiovascular Health

ConditionsSedentary BehaviorSedentary Time
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorUniversity of North Carolina, Chapel Hill

About this trial

There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged between 30-60 years

Insufficiently active: self-reported exercise <90 minutes per week for the past 3 months

Sedentary: self-reported sitting >8 hours per day

Self-reported ability to walk 4 blocks and climb 2 flights of stairs

Disqualifiers

Use of assisted-walking devices

Comorbid condition that would limit the ability to reduce sedentary behavior (e.g., musculoskeletal condition, current chemotherapy)

Plans for major surgery within next 3 months

Recent history (<1 year) of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • One 5-Minute Walking Bout Each Hour

    Behavioral

    One 5-minute light intensity walking break per hour throughout the 4-hour SB condition

  • One 15-Minute Standing Bout Each Hour

    Behavioral

    One 15-minute standing break per hour throughout the 4-hour SB condition

  • One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour

    Behavioral

    Two breaks per hour throughout the 4-hour SB condition, alternating between a 5-minute light intensity walking break and a 15-minute standing break

  • Uninterrupted Sitting

    Behavioral

    No breaks will be provided throughout the 4-hour SB condition. This will be used as the control condition

Treatment groups

56 Participants
are divided into 4 treatment groups
Group A: One 5-Minute Walking Bout Each HourActive comparator 1 intervention
Group B: One 15-Minute Standing Bout Each HourActive comparator 1 intervention
Group C: One 5-Minute Walking Bout and One 15-Minute Standing Bout Each HourActive comparator 1 intervention
Group D: Uninterrupted SittingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Change in Carotid-femoral Pulse Wave Velocity (cfPWV)

cfPWV (m/sec) will be measured between the carotid and femoral arteries, using a collar around the neck and a cuff around the thigh, with the participant in a supine position. cfPWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements

Time frame
Measurements will be taken immediately before and after each 4-hour SB condition

Secondary outcomes

1

Change in Heart-middle Cerebral Artery Pulse Wave Velocity (Brain PWV)

Brain PWV (cm/sec) is the velocity at which a pressure wave travels between the heart and cerebrovascular system. Brain PWV will be calculated from the ECG r-wave to the foot of the Cerebral Blood Flow Velocity (CBFV) waveform

Time frame
Measurements will occur continuously throughout each of the 4-hour SB conditions
2

Mean Change in Femoral-ankle PWV

Femoral-ankle PWV (m/sec) is the velocity at which a pressure wave travels between the femoral-ankle arterial segments. Femoral-ankle PWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements

Time frame
Measurements will be taken immediately before and after each 4-hour SB condition

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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