Breaking of Sitting Time Prevents Lower Leg Swelling (Break_sitting)

January 3, 2022 updated by: Analiza Mónica Lopes Almeida Silva, Faculdade de Motricidade Humana

Breaking of Sitting Time Prevents Lower Leg Swelling - Comparison Among Sit, Stand and Intermittent (Sit-to-stand Transitions) Conditions

Sitting or standing during a prolonged and uninterrupted period of time is related to negative health outcomes, such as lower extremity swelling. It is unknown if interrupting sedentary behavior by including brief bouts of standing up to the sitting time can attenuate lower leg swelling. Thus, our purpose is to examine if breaking sitting time by adding sit-to-stand transitions attenuates or even prevents lower leg swelling, compared with uninterrupted motionless standing and uninterrupted motionless sitting, using localized bioelectrical impedance raw parameters.

Study Overview

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cruz-Quebrada
      • Oeiras, Cruz-Quebrada, Portugal, 1409-002
        • Faculdade de Motricidade Humana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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