- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06938984
Human TECAR on Exercise Preconditioning and Post-exercise Recovery
Study Overview
Status
Conditions
Detailed Description
Fifty male healthy volunteers will be enrolled in a randomized, double-blind (participants and assessors), controlled trial. Volunteers will be allocated in 5 groups of 10 participants each: 1 - Sham-control (fake intervention - massaging with one of the Human TECAR probes with the device turned off before or after the eccentric exercise protocol depending on randomization); 2 - Capacitive mode before exercise (preconditioning); 3 - Resistive mode before exercise (preconditioning); 4 - Capacitive mode after exercise (recovery); and 5 - Resistive mode after exercise (recovery). The treatment target will be the knee extensors muscles (quadriceps).
A standardized knee extension eccentric exercise protocol performed in the isokinetic dynamometer (Biodex System 4) will be used in order to exercise induce skeletal muscle fatigue and damage.
Volunteers will be treated with Human TECAR in a single treatment session, with 10 minutes length, that will be carried out immediately before or immediately after the exercise protocol according to the randomization.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01504-001
- Recruiting
- Laboratory of Phototherapy and Innovative Technologies in Health
-
Contact:
- Heliodora Casalechi, Ph.D., M.Sc., PT.
- Phone Number: +55 11 3385 9134
- Email: ernesto.leal.junior@gmail.com
-
Principal Investigator:
- Pinto Leal Junior, Ph.D., M.Sc., PT.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Physically active male participants;
- Do not present a history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study;
- Are not using pharmacological agents;
- Voluntarily commit to participate in all stages of the study.
Exclusion Criteria:
- Present musculoskeletal or joint injuries during data collection;
- Present history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham-control
Fake intervention - massaging the quadriceps with one of the Human TECAR probes with the device turned off for 10 minutes, before or after the eccentric exercise protocol depending on randomization
|
Massaging the quadriceps with one of the Human TECAR probes with the device turned off for 10 minutes
|
|
Experimental: Capacitive mode before exercise
Capacitive mode applied to the quadriceps for 10 minutes, before the eccentric exercise (preconditioning)
|
Capacitive mode applied to the quadriceps for 10 minutes
|
|
Experimental: Resistive mode before exercise
Resistive mode applied to the quadriceps for 10 minutes, before the eccentric exercise (preconditioning)
|
Resistive mode applied to the quadriceps for 10 minutes
|
|
Experimental: Capacitive mode after exercise (recovery)
Capacitive mode applied to the quadriceps for 10 minutes, after the eccentric exercise (recovery)
|
Capacitive mode applied to the quadriceps for 10 minutes
|
|
Experimental: Resistive mode after exercise (recovery)
Resistive mode applied to the quadriceps for 10 minutes, after the eccentric exercise (recovery)
|
Resistive mode applied to the quadriceps for 10 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle strength
Time Frame: 48 hours after eccentric exercise
|
The muscle strength will be measured through isokinetic dynamometry
|
48 hours after eccentric exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle strength
Time Frame: 5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
The muscle strength will be measured through isokinetic dynamometry
|
5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
|
Change in CK activity
Time Frame: 5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
The CK activity will be analyzed from the blood samples collected from the participants through biochemical analysis and using specific reagent kits.
|
5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
|
Delayed onset muscle soreness - DOMS
Time Frame: 5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
DOMS will be assessed through the VAS scale
|
5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
|
Temperature
Time Frame: 5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
Thigh temperature will be assessed through Thermography using the WellVu camera.
|
5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
|
Muscular oxygen saturation index
Time Frame: 5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
It will be measured using near-infrared spectroscopy (NIRS)
|
5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
|
Muscular blood flow
Time Frame: 5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
It will be measured analyzing total hemoglobin in muscle tissue using near-infrared spectroscopy (NIRS)
|
5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
|
Muscular effort perception
Time Frame: 5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
The CR-100 Effort Perception Scale will be used
|
5 minutes after the treatment, 5 minutes, 1 hour, 24 hours, 72 hours, and 96 hours after the eccentric exercise protocol
|
|
Participant satisfaction with the treatment
Time Frame: 96 hours after the eccentric exercise protocol
|
The Likert scale will be used
|
96 hours after the eccentric exercise protocol
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ernesto Cesar Pinto Leal Junior, Ph.D., M.Sc., PT., Nove de Julho University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 7.083.912
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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