NCT05173558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

November 30, 2021

Last Update Submit

January 3, 2022

Conditions

Keywords

BioimpedanceRaw BIA parametersExtracellular water expansionSedentary behaviour

Outcome Measures

Primary Outcomes (4)

  • Phase Angle (º)

    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)

    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)

    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)

    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 Outcomes (6)

  • Fat Free Mass (kg)

    8 weeks

  • Fat mass (kg)

    8 weeks

  • Weight (kg)

    8 weeks

  • Height (cm)

    8 weeks

  • Blood pressure (mmHg)

    8 weeks

  • +1 more secondary outcomes

Study Arms (3)

Uninterrupted motionless standing

EXPERIMENTAL

20minutes of uninterrupted motionless standing

Behavioral: Uninterrupted motionless standing

Uninterrupted motionless sitting

EXPERIMENTAL

20 minutes of uninterrupted motionless sitting

Behavioral: Uninterrupted motionless sitting

Sit-to-stand transitions

EXPERIMENTAL

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

Behavioral: Sit-to-stand transitions

Interventions

Participants remained 20 minutes of uninterrupted motionless standing

Uninterrupted motionless standing

Participants remained 20 minutes of uninterrupted motionless sitting

Uninterrupted motionless sitting

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

Sit-to-stand transitions

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Self-reported inability to stand for 20min without moving the lower limbs
  • An active smoking status
  • Presence of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Motricidade Humana

Oeiras, Cruz-Quebrada, 1409-002, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 30, 2021

Study Start

March 1, 2020

Primary Completion

June 30, 2020

Study Completion

July 31, 2020

Last Updated

January 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations