Break_sitting: Breaking of Sitting Time Prevents Lower Leg Swelling

Sponsor
Faculdade de Motricidade Humana (Other)
Overall Status
Completed
CT.gov ID
NCT05173558
Collaborator
(none)
20
1
3
5
4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Uninterrupted motionless standing
  • Behavioral: Uninterrupted motionless sitting
  • Behavioral: Sit-to-stand transitions
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Breaking of Sitting Time Prevents Lower Leg Swelling - Comparison Among Sit, Stand and Intermittent (Sit-to-stand Transitions) Conditions
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jul 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Uninterrupted motionless standing

20minutes of uninterrupted motionless standing

Behavioral: Uninterrupted motionless standing
Participants remained 20 minutes of uninterrupted motionless standing

Experimental: Uninterrupted motionless sitting

20 minutes of uninterrupted motionless sitting

Behavioral: 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)

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

Outcome Measures

Primary Outcome Measures

  1. Phase Angle (º) [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) [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) [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) [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 Outcome Measures

  1. Fat Free Mass (kg) [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) [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) [8 weeks]

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

  4. Height (cm) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculdade de Motricidade Humana Oeiras Cruz-Quebrada Portugal 1409-002

Sponsors and Collaborators

  • Faculdade de Motricidade Humana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Analiza Mónica Lopes Almeida Silva, Assistant Professor, Faculdade de Motricidade Humana
ClinicalTrials.gov Identifier:
NCT05173558
Other Study ID Numbers:
  • Break_Sitt
First Posted:
Dec 30, 2021
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Analiza Mónica Lopes Almeida Silva, Assistant Professor, Faculdade de Motricidade Humana

Study Results

No Results Posted as of Jan 18, 2022