Breaking of Sitting Time Prevents Lower Leg Swelling
Break_sitting
1 other identifier
interventional
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedFirst Submitted
Initial submission to the registry
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
December 30, 2021
CompletedJanuary 18, 2022
January 1, 2022
4 months
November 30, 2021
January 3, 2022
Conditions
Keywords
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
EXPERIMENTAL20minutes of uninterrupted motionless standing
Uninterrupted motionless sitting
EXPERIMENTAL20 minutes of uninterrupted motionless sitting
Sit-to-stand transitions
EXPERIMENTAL20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing)
Interventions
Participants remained 20 minutes of uninterrupted motionless standing
Participants remained 20 minutes of uninterrupted motionless sitting
20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing)
Eligibility Criteria
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
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