Sitting Interruption and Whole-body Cardiovascular Health

Sedentary Behavior Clinical Trial

— SWITCH  

Official title:

Sitting Interruption and Whole-body Cardiovascular Health: Linking Physiological Responses to Risk Behaviors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316571
• Other study ID #: 21-3195
• Secondary ID: 1R01HL157187-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: October 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Simon Higgins, PhD
• Phone: (706) 461-6776
• Email: higginss[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Sedentary behaviors (SB) are biologically distinct but understudied heart disease risk factors. National and international agencies have concluded that the level of evidence for an overall and dose-response association between SB and heart disease mortality is moderate-strong. These agencies do not provide specific recommendations for breaking-up SB, though do call on the research community to facilitate policy development by establishing biological plausibility, identifying the optimal dose for SB substitution strategies, and conducting randomized clinical trials to test the efficacy of these strategies. Accordingly, the goal of this study is to identify mechanism-informed, socioecological-based SB substitution recommendations to reduce heart disease risk. To achieve this goal, two aims will be addressed. Aim 1 will identify a feasible SB substitution strategy to prevent the negative cardiovascular responses to prolonged SB (i.e., strategies that people will actually follow). Adverse cardiovascular responses to prolonged SB will be measured using aortic arterial stiffness (AS), a noninvasive test that predicts future heart disease. To accomplish this aim, 56 middle-aged (36-55 years) participants will provide written informed consent, prior to the measurement of aortic AS and associated mechanistic responses to the following over 4 hours, in a randomized crossover manner: (i) SB with a 5-minute walk break once per hour; (ii) SB with a 15-minute standing break once per hour; (iii) SB with two breaks per hour, alternating between a 5-minute walk and a 15-minute stand; and (iv) SB with no breaks (control). These strategies were selected based on extensive prior work by the investigators, and because they are feasible, which is a key component of this study. SB reduction strategies will only decrease heart disease risk if people are willing to adhere to future SB substitution recommendations. To increase the likelihood of feasibility and long-term adherence, Aim 2 will evaluate the determinants of SB using a socioecological model. This recognizes that behavior change is likely to be limited if the physical and sociocultural environments do not support the behavior change. To accomplish Aim 2, a combined inductive-deductive qualitative approach will be used. Participants who complete Aim 1 will participate in one of 6 focus groups (6-8 participants/group). Crucially, the outcomes from this proposal will be instrumental in helping to design a subsequent clinical trial to test a mechanism-informed yet feasible SB reduction intervention, and in doing so directly support the development of SB policy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Years to 55 Years

Eligibility

Inclusion Criteria:

• Aged between 36-55 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

• Possession of cellular phone able to receive text messages

Exclusion Criteria:

• 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

• Recent (< 1 year) or planned bariatric surgery

• Systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg

• Current or recent (within last 6 months) pregnancy; current or recent (within last 3 months) breastfeeding

• Morbidly obesity (BMI >40 kg/m^2) or underweight (BMI <18.5 kg/m^2)

• Use of anti-hypertensive drugs

• Use of glucose-controlling medication

• Heavy alcohol consumption (>15 drinks per week)

Related Conditions & MeSH terms

• Sedentary Behavior
• Sedentary Time

Intervention

Behavioral:
• One 5-Minute Walking Bout Each Hour
One 5-minute light intensity walking break per hour throughout the 4-hour SB condition
• One 15-Minute Standing Bout Each Hour
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
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
No breaks will be provided throughout the 4-hour SB condition. This will be used as the control condition

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Higgins S, Cowley ES, Paterson C, Hanson ED, Dave GJ, Meyer ML, Lin FC, Gibbs BB, Vu M, Stoner L. Protocol for a study on Sitting with Interruption and Whole-Body Cardiovascular Health (SWITCH) in middle-aged adults. Contemp Clin Trials. 2023 Feb;125:107048. doi: 10.1016/j.cct.2022.107048. Epub 2022 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurements will be taken immediately before and after each 4-hour SB condition
Secondary	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	Measurements will occur continuously throughout each of the 4-hour SB conditions
Secondary	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	Measurements will be taken immediately before and after each 4-hour SB condition