NCT05583500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

October 17, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 29, 2022

Last Update Submit

October 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pain: VAS

    change from baseline to 72 hours

  • Quadriceps thickness

    change from baseline to 72 hours

  • Creatinkinase (CK concentration)

    change from baseline to 72 hours

  • cellular inflammatory markers

    change from baseline to 72 hours

  • Leg power

    change from baseline to 72 hours

Study Arms (1)

Single group: excentric exercise protocol

EXPERIMENTAL

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

Interventions

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

Single group: excentric exercise protocol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjets
  • Sedentary subjects

You may not qualify if:

  • Trained subjects
  • Subjects with musculoskeletal pathology
  • Previous Surgeries in the last 6 months
  • Subjects under pharmacological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Study Officials

  • Jorge Buffet García

    Universidad Francisco de Vitoria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Buffet García

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 17, 2022

Study Start

September 19, 2022

Primary Completion

December 19, 2022

Study Completion

January 10, 2023

Last Updated

October 17, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations