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

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.

Study Overview

• Status: Recruiting
• Conditions: Phase Angle
• Intervention / Treatment: Other: Experimental: Single group: excentric exercise protocol

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge Buffet García; Phone Number: +34619903972; Email: j.buffet.prof@ufv.es

Study Locations

• Spain
  • Madrid
    • Pozuelo De Alarcón, Madrid, Spain, 28223
      • Recruiting
      • Universidad Francisco de Vitoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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°/π).	change from baseline to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quadriceps thickness	Quadriceps muscle thickness will be measures in mm. by an ultrasound device	change from baseline to 72 hours
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
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
Leg power	Leg power will be assessed using vertical jump test, with Chronojump platform (CHRONOJUMP Boscosystem)	change from baseline to 72 hours

Collaborators and Investigators

• Sponsor: Universidad Francisco de Vitoria
• Investigators: Principal Investigator: Jorge Buffet García, Universidad Francisco de Vitoria

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Anticipated): December 19, 2022
• Study Completion (Anticipated): January 10, 2023

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: UFV-JB22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No