Sedentary Behavior Interrupted - A Pilot Study of Acute Interventions on Prolonged Sitting

Completed · Not applicable

Conditions studied: Sedentary Lifestyle

In brief

Sedentary behavior, characterized by excess sitting time during waking hours, is detrimental to health and increases cardiometabolic disease risk, independent of moderate-to-vigorous physical activity. The mechanisms that mediate this are unknown and there are no evidence-based methods known for effectively intervening on sedentary behavior. The consequences of prolonged sitting time are of particular interest in older adults as sedentary behavior and cardiometabolic disease risk both increase with aging and moderate-to-vigorous physical activity may not be feasible. This pilot study will assess interventions for sedentary older adults designed to interrupt prolonged sitting time. Interrupting sitting time through sit-to-stand transitions, and standing and walking breaks increases muscle use and blood flow in the lower parts of the body. Thus, the investigators believe that frequent sit-to-stand interruptions of sitting time are the most efficacious sedentary behavior interventions, compared to simply reducing sitting time or less frequent walking breaks, for improving health outcomes and healthy aging. The investigators hypothesize that frequency of sit-to-stands during a 5-hour sitting period will result in health benefits that can be observed with a simple 2-minute standing interruption, and that this will be associated with improvements in metabolism and endothelial function. This pilot, 10-participant study will 1) generate preliminary data for a revised Program Project Grant application to the National Institute of Aging (NIA) that focuses on postmenopausal women, the fastest growing aged population with high life-time risk of cardiometabolic risk. This pilot study will inform sitting interruption modality design for two projects in the investigators' Program Project Grant application: "Project 1: Sedentary Behavior Interrupted: A randomized crossover treatment trial of acute effects on biomarkers of healthy aging in the laboratory (86 participants)" and "Project 2: Sedentary Behavior Interrupted: A randomized trial of 6 month effects on biomarkers of healthy aging and physical functioning in the real world (660 participants)." The current design of this pilot study is enhanced by and responsive to feedback from our initial NIA submission. This pilot study will increase our knowledge about how sedentary behavior and sitting interruption interventions influence healthy aging in postmenopausal women.

Key facts

Study ID

NCT02743286

Run by

University of California, San Diego

People needed

10

Starts

2016-04-01

Expected to finish

2016-07-01

Last updated by the study team

2016-09-08

Who can join

Age: 55 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Postmenopausal woman, any ethnicity/race, 55+ years of age.
• Ambulatory, medically stable, able to give informed consent, and safely complete the protocols.
• Fluent in the English language.
• Body Mass Index range of 27-45kg/m2.
• Sedentary: Average ≥6hr sitting time, and <20min physical activity on 3 or more days per week, as assessed by self report.

You may not qualify if…

• Mental states that would preclude complete understanding of the protocol and compliance.
• Chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease).
• Body Mass Index <27 or >45kg/m2.
• Anemia (hemoglobin ≤11g/dL) - determined by CBC test done at screening.
• Arthritis or degenerative joint disease affecting knees where repeated sitting/standing interruptions might cause pain.
• Personal or family history of venous thrombosis.
• Type 1 diabetes mellitus
• Poorly controlled hypertension (SBP ≥165 or DBP ≥100).
• Weight instability in past 3 months (no more than 5% up or down).
• Participants <65 years of age with HbA1c ≥53 mmol/mol (7%) and participants ≥65 years of age with HbA1c ≥58mmol/mol (7.5%) will be excluded for uncontrolled diabetes.34,35
• Use of insulin medications.
• Regular use of vasodilator medication AND high risk of stroke and/or heart attack (i.e., history of multiple hospitalizations (>2X in the last 6 months), congestive heart failure, atrial fibrillation, and/or stroke).
• Use of any immunosuppressant or corticosteroid medication.
• Use of medications that might cause weight change (e.g., second generation anti-psychotics).
• < 6hr average daily sitting time.
• ≥20min physical activity average on 3 or more days per week 18) Participating in another clinical trial. 19) Blood donation less than 56 days prior to screening visit. 20) Smoking cigarettes or anything, and other use of tobacco products.

Where it is running

• University of California, San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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