Breaking of Sitting Time Prevents Lower Leg Swelling

Edema Leg Clinical Trial

— Break_sitting  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173558
• Other study ID #: Break_Sitt
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: January 2022
• Source: Faculdade de Motricidade Humana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema Leg

Intervention

Behavioral:
• Uninterrupted motionless standing
Participants remained 20 minutes of uninterrupted motionless standing
• Uninterrupted motionless sitting
Participants remained 20 minutes of uninterrupted motionless sitting
• Sit-to-stand transitions
20 minutes of sit-to-stand transitions (1 minute sitting with 1 minute standing)

Locations

Country	Name	City	State
Portugal	Faculdade de Motricidade Humana	Oeiras	Cruz-Quebrada

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Motricidade Humana

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	8 weeks
Secondary	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.	8 weeks
Secondary	Weight (kg)	Weight was measured in bathing suit and no shoes to the nearest 0.01kg using a weight scale.	8 weeks
Secondary	Height (cm)	Height was measured in bathing suit and no shoes to the nearest 0.1cm using a a stadiometer (Seca, Hamburg, Germany), respectively.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks