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OpenTrials
Completed

NCT Number: NCT05173558

Breaking of Sitting Time Prevents Lower Leg Swelling

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Motricidade Humana

Oeiras, Cruz-Quebrada, 1409-002, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uninterrupted motionless standing

Behavioral

Participants remained 20 minutes of uninterrupted motionless standing

Uninterrupted motionless sitting

Behavioral

Participants remained 20 minutes of uninterrupted motionless sitting

Sit-to-stand transitions

Behavioral

20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing)

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. 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

  2. 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.

  3. Weight (kg)

    Time frame: 8 weeks

    Weight was measured in bathing suit and no shoes to the nearest 0.01kg using a weight scale.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Faculdade de Motricidade Humana

Other

Registry information

Official study title

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

Acronym: Break_sitting

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2021
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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