Edema LegBreak_sittingNCT05173558
Breaking of Sitting Time Prevents Lower Leg Swelling
A study testing Uninterrupted motionless standing, Uninterrupted motionless sitting and Sit-to-stand transitions in people with Edema Leg, run by Faculdade de Motricidade Humana at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Edema Leg
- What is being tested?
- Uninterrupted motionless standing, Uninterrupted motionless sitting and Sit-to-stand transitions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Self-reported inability to stand for 20min without moving the lower limbs
- An active smoking status
- Presence of diabetes
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Motricidade Humana
Oeiras, Cruz-Quebrada, 1409-002
About this study
Official title: 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.
Read the 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.
- Conditions
- Edema Leg
- Being tested
- Uninterrupted motionless standing, Uninterrupted motionless sitting, Sit-to-stand transitions
- Keywords
- Bioimpedance, Raw BIA parameters, Extracellular water expansion, Sedentary behaviour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uninterrupted motionless standingBehavioural
Participants remained 20 minutes of uninterrupted motionless standing
Uninterrupted motionless sittingBehavioural
Participants remained 20 minutes of uninterrupted motionless sitting
Sit-to-stand transitionsBehavioural
20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing)
| Study group | Role | What they receive |
|---|---|---|
| Uninterrupted motionless standing | Experimental | 20minutes of uninterrupted motionless standing Receives: Behavioral: Uninterrupted motionless standing |
| Uninterrupted motionless sitting | Experimental | 20 minutes of uninterrupted motionless sitting Receives: Behavioral: Uninterrupted motionless sitting |
| Sit-to-stand transitions | Experimental | 20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing) Receives: Behavioral: Sit-to-stand transitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8 weeks
Secondary outcomes (6)
Fat Free Mass (kg)
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
Measured: 8 weeks
Fat mass (kg)
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.
Measured: 8 weeks
Weight (kg)
Weight was measured in bathing suit and no shoes to the nearest 0.01kg using a weight scale.
Measured: 8 weeks
Height (cm)
Height was measured in bathing suit and no shoes to the nearest 0.1cm using a a stadiometer (Seca, Hamburg, Germany), respectively.
Measured: 8 weeks
Blood pressure (mmHg)
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.
Measured: 8 weeks
Heart Rate (bpm)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Mar 2020
- Primary completion30 Jun 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Analiza Mónica Lopes Almeida Silva, Faculdade de Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173558
- Sponsor's protocol ID
- Break_Sitt
- Acronym
- Break_sitting
- Status last verified
- Jan 2022
- First submitted
- 30 Nov 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking of Sitting Time Prevents Lower Leg Swelling - Comparison Among Sit, Stand and Intermittent (Sit-to-stand Transitions) Conditions
- ClinicalTrials.gov ID
- NCT05173558
- Acronym / sponsor ID
- Break_sitting / Break_Sitt
- Conditions
- Edema Leg
- Keywords
- Bioimpedance, Raw BIA parameters, Extracellular water expansion, Sedentary behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Uninterrupted motionless standing | Experimental | Behavioral: Uninterrupted motionless standing20minutes of uninterrupted motionless standing |
| Uninterrupted motionless sitting | Experimental | Behavioral: Uninterrupted motionless sitting20 minutes of uninterrupted motionless sitting |
| Sit-to-stand transitions | Experimental | Behavioral: Sit-to-stand transitions20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Self-reported inability to stand for 20min without moving the lower limbs
- An active smoking status
- Presence of diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uninterrupted motionless standingParticipants remained 20 minutes of uninterrupted motionless standing | Behavioural | Uninterrupted motionless standing |
| Uninterrupted motionless sittingParticipants remained 20 minutes of uninterrupted motionless sitting | Behavioural | Uninterrupted motionless sitting |
| Sit-to-stand transitions20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing) | Behavioural | Sit-to-stand transitions |
Primary outcome
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).
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).
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).
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).
6 secondary outcomes
Fat Free Mass (kg)
Time frame: 8 weeks
Fat mass (kg)
Time frame: 8 weeks
Weight (kg)
Time frame: 8 weeks
Height (cm)
Time frame: 8 weeks
Blood pressure (mmHg)
Time frame: 8 weeks
Heart Rate (bpm)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uninterrupted motionless standing, Uninterrupted motionless sitting and Sit-to-stand transitions in people with Edema Leg, run by Faculdade de Motricidade Humana at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Angle (º) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.