Health Effects of Increasing Muscle Activation While Sitting in Office Workers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02855541

Enrollment

Registered

2016-08-04

Start date

2016-08-31

Completion date

2017-06-30

Last updated

2018-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

Blood Glucose, Physical Fitness, Body Composition, Lipids

Brief summary

Previous research suggests that prolonged sitting increases risk for cardiometabolic diseases and the risk factors associated with cardiometabolic diseases. However, no study to date has examined if a chronic intervention that breaks up prolonged sitting in a real-world environment results in a reduction in the metabolic risk factors associated with cardiometabolic diseases. Thus, the objective of this study is to examine the potential health benefits of breaking up sitting bouts throughout the workday using a small cycling device (DeskCycle) in office workers involved with jobs that require prolonged bouts of sitting. The investigators hypothesize that breaking up sitting will be associated with improvements in cardiometabolic disease risk factors. More specifically, the investigators hypothesize that breaking up sitting will decrease blood glucose during an oral glucose tolerance test (OGTT), increase cardiorespiratory fitness (VO2max), decrease blood pressure, decrease body fat, increase HDL cholesterol, and decrease LDL cholesterol, total cholesterol, and triglycerides.

Interventions

DEVICEDeskCycle

A small cycling ergometer that can fit under a desk at the workplace.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Both males and females * Subjects will need to be 18-55 years old * Subjects will need to be sitting at least 6 hours/day on 5 days/week * Subjects will need to be exercising less than 5 hour/week

Exclusion criteria

* Females that are pregnant or breast-feeding. * Subjects must be free from any acute or chronic physical condition that would influence the outcome measures of the protocol. Examples include, but are not limited to advanced chronic disease states (chronic kidney, liver, heart, or lung disease), morbid obesity, emphysema, and an inability to use the legs for normal locomotion. Normality will be established on the basis of clinical history, physical exam, and vital signs. Any subject with a history of an uncontrolled metabolic disorder/disease or symptoms of active illness will be excluded from study. Any subject with a history of an uncontrolled metabolic disorder/disease such as diabetes (Type I or Type II) or symptoms of active illness will be excluded from study. * Subjects will be excluded if they have a fasted blood glucose level \>126 mg/dl or a systolic blood pressure \>140 mmHg. * Medical/psychiatric/sleep disorders history: any clinically significant unstable medical or psychological condition within the last year (treated or untreated). * Drug use: * Use of any medications, including over-the-counter and herbal products, that may affect metabolic function within 1 month prior to the study or need to use any of these medications at any time during the study (self-report by interview). Examples of potential medications that will exclude a subject include: beta-adrenergic blockers, sulfonylureas, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, and dipeptidyl peptidase IV inhibitors. Note, subjects may be tested at a later date. * Use of any investigational drug within 1 month before the study

Design outcomes

Primary

Measure	Time frame	Description
Blood Glucose	Measured after 4 weeks	2-h Post Oral Glucose Tolerance Test Blood Glucose
Maximum Oxygen Consumption	Measured after 4 weeks	Maximum oxygen consumption (VO2max) will be used to determine physical fitness

Secondary

Measure	Time frame
LDL Cholesterol	Measured after 4 weeks
Triglycerides	Measured after 4 weeks
Systolic Blood Pressure	Measured after 4 weeks
Fat Mass	Measured after 4 weeks
Lean Mass	Measured after 4 weeks
HDL Cholesterol	Measured after 4 weeks

Countries

United States

Participant flow

Participants by arm

Arm	Count
Cycling Intervention Participants will use a small cycling device (DeskCycle) at their workstation for 15 minutes every hour that they are at work. DeskCycle: A small cycling ergometer that can fit under a desk at the workplace.	21
Total	21

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Change in health status	2
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Cycling Intervention
Age, Continuous	34.8 years STANDARD_DEVIATION 9.9
Blood Glucose	5.41 mmol/L STANDARD_DEVIATION 1.21
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Fat Mass	28.5 kg STANDARD_DEVIATION 13
HDL Cholesterol	1.09 mmol/L STANDARD_DEVIATION 0.17
LDL Cholesterol	2.50 mmol/L STANDARD_DEVIATION 0.67
Lean Mass	47.8 kg STANDARD_DEVIATION 8.1
Maximum Oxygen Consumption (VO2max)	2.07 L/min STANDARD_DEVIATION 0.44
Region of Enrollment United States	21 participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	7 Participants
Systolic Blood Pressure	112.2 mmHg STANDARD_DEVIATION 10.3
Triglycerides	1.16 mmol/L STANDARD_DEVIATION 0.64
Work Sitting	7.04 hours STANDARD_DEVIATION 0.78

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 25
serious Total, serious adverse events	0 / 25