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

Primary Purpose

Phase Angle

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental: Single group: excentric exercise protocol
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Phase Angle

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Francisco de VitoriaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group: excentric exercise protocol

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain: VAS
Visual Analogic Scale. Pain will be measured with a visual analog scale from 0 to 10. 0 points is no pain.
Quadriceps thickness
Quadriceps muscle thickness will be measures in mm. by an ultrasound device
Creatinkinase (CK concentration)
CK concentration will be measure in mg/dl with a portal analyzer (SpotchemTM EZ SP-4430), using test strips.
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
Leg power
Leg power will be assessed using vertical jump test, with Chronojump platform (CHRONOJUMP Boscosystem)

Full Information

First Posted
September 29, 2022
Last Updated
October 13, 2022
Sponsor
Universidad Francisco de Vitoria
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1. Study Identification

Unique Protocol Identification Number
NCT05583500
Brief Title
Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise
Official Title
Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
December 19, 2022 (Anticipated)
Study Completion Date
January 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phase Angle

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single group: excentric exercise protocol
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Experimental: Single group: excentric exercise protocol
Intervention Description
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
Primary Outcome Measure Information:
Title
Phase angle
Description
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).
Time Frame
change from baseline to 72 hours
Secondary Outcome Measure Information:
Title
Pain: VAS
Description
Visual Analogic Scale. Pain will be measured with a visual analog scale from 0 to 10. 0 points is no pain.
Time Frame
change from baseline to 72 hours
Title
Quadriceps thickness
Description
Quadriceps muscle thickness will be measures in mm. by an ultrasound device
Time Frame
change from baseline to 72 hours
Title
Creatinkinase (CK concentration)
Description
CK concentration will be measure in mg/dl with a portal analyzer (SpotchemTM EZ SP-4430), using test strips.
Time Frame
change from baseline to 72 hours
Title
cellular inflammatory markers
Description
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
Time Frame
change from baseline to 72 hours
Title
Leg power
Description
Leg power will be assessed using vertical jump test, with Chronojump platform (CHRONOJUMP Boscosystem)
Time Frame
change from baseline to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Buffet García
Phone
+34619903972
Email
j.buffet.prof@ufv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Buffet García
Organizational Affiliation
Universidad Francisco de Vitoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Francisco de Vitoria
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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