Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise

Phase Angle Clinical Trial

Official title:

Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583500
• Other study ID #: UFV-JB22
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: September 2022
• Source: Universidad Francisco de Vitoria
• Contact: Jorge Buffet García
• Phone: +34619903972
• Email: j.buffet.prof[@]ufv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study will be to assess the effectiveness of bioimpedance device (BIA) as a safe, rapid, and non-invasive method of analyzing muscle damage induced by high intensity induced eccentric exercise as an alternative measurement tool against traditional assessment methods.

A sample of 28 sedentary subjects will be recruited, all participants will perform an eccentric exercise protocol.

Measurements will be done before performing the exercise protocol, immediately after finishing the protocol, 3h after the end of the exercise protocol, 24h after the end of the exercise protocol and 48h after the end of the exercise protocol.

The variables analyzed in all subjects will be phase angle, creatinkinase, jumping strength, VAS scale, white blood count cell, quadriceps muscle thickness, Borg scale and anxiety and depression questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: January 10, 2023
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy subjets

• Sedentary subjects

Exclusion Criteria:

• Trained subjects

• Subjects with musculoskeletal pathology

• Previous Surgeries in the last 6 months

• Subjects under pharmacological treatment

Related Conditions & MeSH terms

• Inflammation
• Phase Angle

Intervention

Other:
• Experimental: Single group: excentric exercise protocol
Excentric exercise protocol will be performed for all subjets, consisted of 10 sets of 20 repetitions of squats, jumping from a height of 50 cm

Locations

Country	Name	City	State
Spain	Universidad Francisco de Vitoria	Pozuelo De Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase angle	The phase angle, which is measured via bioelectrical impedance analysis (BIA), InBody 770 ,is a clinically important bioimpedance parameter used for nutritional assessment and evaluating the risk of various diseases. The phase angle was calculated automatically by the BIA device from these two components according to the following formula: phase angle (°) = (reactance/resistance) × (180°/p).	change from baseline to 72 hours
Secondary	Pain: VAS	Visual Analogic Scale. Pain will be measured with a visual analog scale from 0 to 10. 0 points is no pain.	change from baseline to 72 hours
Secondary	Quadriceps thickness	Quadriceps muscle thickness will be measures in mm. by an ultrasound device	change from baseline to 72 hours
Secondary	Creatinkinase (CK concentration)	CK concentration will be measure in mg/dl with a portal analyzer (SpotchemTM EZ SP-4430), using test strips.	change from baseline to 72 hours
Secondary	cellular inflammatory markers	Cellular inflammatory markers will be measured with hematology analyzer (Sysmex KX-21N Automed) in 10^9/L and % White blood count, lymphocytes, neutrophils, monocytes, eosinophils, basophils will be analyzed	change from baseline to 72 hours
Secondary	Leg power	Leg power will be assessed using vertical jump test, with Chronojump platform (CHRONOJUMP Boscosystem)	change from baseline to 72 hours