- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173558
Breaking of Sitting Time Prevents Lower Leg Swelling (Break_sitting)
Breaking of Sitting Time Prevents Lower Leg Swelling - Comparison Among Sit, Stand and Intermittent (Sit-to-stand Transitions) Conditions
Study Overview
Status
Conditions
Detailed Description
Increased sedentary behavior has deleterious effects on cognitive function, mental health, physical function, disability as well as quality-of-life. Nowadays, prolonged sitting time has been introduced into many situations such as transportation and in the workplace. Staying in the same position (e.g., sitting/standing) for a long and uninterrupted period is associated with poorer health-outcomes, increasing the risk for premature mortality. For instance, sitting for a long period of time has been associated with lower limbs edema. This condition causes discomfort and pain, in turn associated with a lower quality-of-life.
The literature shows that interruption of prolonged sitting time has a positive impact in several health-related risk factors. However, no studies analyzed the effects of motionless sitting with brief standing bouts on lower leg swelling. Thus, the aim of this study is to examine and to compare the effects of standing, sitting and sit-to-stand transitions on lower leg swelling using localized bioelectrical impedance analysis (BIA) measurements A crossover randomized experiment was performed among 20 healthy individuals [age: 27.5±5.9y, 47% females]. In this study, the participants performed the 3 conditions (randomly ordered): 1) uninterrupted motionless standing; 2) uninterrupted motionless sitting; 3) sit-to-stand transitions (1 minute sitting followed by 1 minute standing). Before each condition, a 10-min resting period was performed. Total fat and fat-free mass were determined by dual-energy x-ray absorptiometry. Localized resistance (R), reactance (Xc), impedance (Z) and phase angle (PhA) were assessed at the baseline, at 10 min and at 20 min for each condition.
The researchers hypothesized that interrupting a prolonged sitting position with sit-to-stand transitions will result in greater muscle pump, preventing lower leg swelling.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cruz-Quebrada
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Oeiras, Cruz-Quebrada, Portugal, 1409-002
- Faculdade de Motricidade Humana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI ranging between 18.5 to 29.9 kg/m2;
- Not taking any medications at the time of the measurements;
- All women should have a (self-reported) regular menstrual cycle.
Exclusion Criteria:
- Self-reported inability to stand for 20min without moving the lower limbs
- An active smoking status
- Presence of diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Uninterrupted motionless standing
20minutes of uninterrupted motionless standing
|
Participants remained 20 minutes of uninterrupted motionless standing
|
|
Experimental: Uninterrupted motionless sitting
20 minutes of uninterrupted motionless sitting
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Participants remained 20 minutes of uninterrupted motionless sitting
|
|
Experimental: Sit-to-stand transitions
20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing)
|
20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phase Angle (º)
Time Frame: 8 weeks
|
The bioimpedance AKERN BIA 101/BIVA PRO was used to assess physical parameters.
Akern is a phase-sensitive device that measures phase angle (PhA).
|
8 weeks
|
|
Impedance (Ohm)
Time Frame: 8 weeks
|
The bioimpedance AKERN BIA 101/BIVA PRO was used to assess physical parameters.
Akern is a phase-sensitive device that measures impedance (Z).
|
8 weeks
|
|
Resistance (Ohm)
Time Frame: 8 weeks
|
The bioimpedance AKERN BIA 101/BIVA PRO was used to assess physical parameters.
Akern is a phase-sensitive device that measures phase angle (PhA) and impedance (Z), and then calculates resistance (R).
|
8 weeks
|
|
Reactance (Ohm)
Time Frame: 8 weeks
|
The bioimpedance AKERN BIA 101/BIVA PRO was used to assess physical parameters.
Akern is a phase-sensitive device that measures phase angle (PhA) and impedance (Z), and then calculates reactance (Xc).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat Free Mass (kg)
Time Frame: 8 weeks
|
Dual-energy X-ray absorptiometry (DXA; Hologic Explorer-W, Waltham, USA) was used to determine fat-free mass (FFM).
A whole-body scan was performed, and the attenuation of X-rays pulsed between 70 and 140kV synchronously with the line frequency for each pixel of the scanned image was measured
|
8 weeks
|
|
Fat mass (kg)
Time Frame: 8 weeks
|
Dual-energy X-ray absorptiometry (DXA; Hologic Explorer-W, Waltham, USA) was used to determine total fat mass (FM).
A whole-body scan was performed, and the attenuation of X-rays pulsed between 70 and 140kV synchronously with the line frequency for each pixel of the scanned image was measured.
|
8 weeks
|
|
Weight (kg)
Time Frame: 8 weeks
|
Weight was measured in bathing suit and no shoes to the nearest 0.01kg using a weight scale.
|
8 weeks
|
|
Height (cm)
Time Frame: 8 weeks
|
Height was measured in bathing suit and no shoes to the nearest 0.1cm using a a stadiometer (Seca, Hamburg, Germany), respectively.
|
8 weeks
|
|
Blood pressure (mmHg)
Time Frame: 8 weeks
|
Blood pressure was measured (seated and bipedal) right before the start of each protocol.
During the experimental condition, blood pressure was measured every 5 minutes.
|
8 weeks
|
|
Heart Rate (bpm)
Time Frame: 8 weeks
|
Heart rate was measured (seated and bipedal) right before the start of each protocol.
During the experimental condition, heart rate was measured every 5 minutes.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Break_Sitt
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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