Muscle StrengthNCT04888520
Strength and Muscle Activation of Runners Quadriceps After 8 Weeks of Intervention With Elastic Bandage
A study testing Adhesive elastic bandage in people with Muscle Strength, run by Rodrigo Antonio Carvalho Andraus.
Trial summary
It is a controlled and randomized clinical trial with the objective of verifying the acute and chronic effects (8 weeks) of elastic banding in runners. Thus, we have as hypotheses of this research: The elastic bandage indirectly influences the muscular strength to the extent that it supposedly can alter the muscular… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength
- What is being tested?
- Adhesive elastic bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being between 18 and 60 years old;
- being physically able to participate in the experimental study;
- being completely independent in carrying out basic activities of daily living;
- not having a physical, hearing or visual impairment that prevents the exams from being performed or making use of prostheses or orthopedic orthoses;
- having no history of injury to the knee, ankle or hip;
- has no allergy to elastic bandages;
Show all 9Show fewer
- having time to participate in the interventions;
- has no cognitive impairment according to the Mini Mental State Examination (MMSE);
- has a training frequency of at least twice a week for more than three months.
Who cannot join
- Participants who fail to complete evaluations and/or interventions for any reason
- Participants who, for some reason, decide to withdraw consent for the research will be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Strength and Muscle Activation of Runners Quadriceps After Eight Weeks of Intervention With Elastic Bandage - A Randomized Controlled Clinical Trial
It is a controlled and randomized clinical trial with the objective of verifying the acute and chronic effects (8 weeks) of elastic banding in runners. Thus, we have as hypotheses of this research: The elastic bandage indirectly influences the muscular strength to the extent that it supposedly can alter the muscular activation verified through the surface electromyography in individuals submitted to the training as the running training. The elastic bandage has clinical significance, however, it does not present statistical significance on muscle strength and activation in individuals submitted to training as running training. To confirm these hypotheses, the muscle strength of the flexors and extensors of the right knee will be checked by means of the isokinetic dynamometer and the muscular activation of the extensors of the right knee (rectus femoris muscle) will be assessed by means of surface electromyography. The elastic bandage will be applied according to a specific protocol in "I" over the muscular belly of the right femoral rectus muscle (which will be submitted to evaluations). All participants will be evaluated without applying adhesive tape and will receive the first application of the tape without tension. Then, after 20 minutes of rest, they will be reassessed with the tape. Participants will be randomized into two groups and both will receive the adhesive tape (with or without tension according to randomization). Then the evaluations will be repeated (all will be reevaluated without the tape and with the tape (with or without tension according to the protocol).
Read the detailed description
It is a controlled and randomized clinical trial in order to verify the acute and chronic effects (8 weeks of application) of the elastic bandage in runners. hus, we have as hypotheses of this research: The elastic bandage indirectly influences the muscular strength to the extent that it supposedly can alter the muscular activation verified through the surface electromyography in individuals submitted to the training as the running training. The elastic bandage has clinical significance, however, it does not present statistical significance on muscle strength and activation in individuals submitted to training as running training. To confirm these hypotheses, the muscle strength of the flexors and extensors of the right knee will be checked by means of the isokinetic dynamometer and the muscular activation of the extensors of the right knee (rectus femoris muscle) will be assessed by means of surface electromyography. The elastic bandage will be applied according to a specific protocol in "I" over the muscular belly of the right femoral rectus muscle (which will be submitted to evaluations). Initially all participants will be evaluated without applying adhesive tape and, in sequence, they will receive the first application of the tape (for all participants, the tape will be applied without tension) and after 20 minutes of rest, they will be reassessed with the application of the adhesive tape . After the initial assessment, participants will be randomized into two groups and both will receive adhesive tape. The FT (free tension) group will have no tension in any of its tape applications; and the WT (with tension) group will have progressive tension over 8 weeks of intervention (with reduction of the tape length over the weeks, in relation to the same size of the applied area, which generates a longitudinal tension of the tape in relation to skin of the participant). In the eighth and last week of intervention, before the last application of the tape, everyone will be evaluated again (strength and muscle activation) without the tape. Then, the last application of the tape will be performed with or without tension (according to their respective groups) and after 20 minutes of rest, the evaluation of all participants will be performed again with the last application of the tape to the rectus femoris muscle.
- Conditions
- Muscle Strength
- Being tested
- Adhesive elastic bandage
- Keywords
- Muscle strength, Peak Torque, Electromyography, Athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesive elastic bandageDevice
Also called Kinesio Tape, Kinesio Taping, Kinesiotape, Kinesiotaping
The base of the tape should be applied 5 cm below the origin of the rectus femoris (lower anterior iliac spine), going towards its insertion (base of the patella, through supra-patellar ligament), without tension in this part of the tape (2 to 3 cm initial) in order to avoid discomfort. The application mode will be in "I" ("I-strip"). The participants will be in the supine position, with the hip flexed at 30° and the knee flexed at 60°. The applications of the tape will be carried out every Monday, before the first day of running training of the week and should remain until Friday, when it will be removed by the researcher after the last day of running training of the week. If the elastic bandage unstuck alone from the skin before this period, the event should be immediately reported to the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Tensioning protocol of the elastic bandage (WT) | Experimental | The group will have progressive tension throughout the week - based on the reduction of the tape in relation to the size of the applied area (which will always be the same), which generates a longitudinal tension of the tape in relation to the participant's skin. The Therapy Tex® brand has the elastic deformation capability of up to 40%. The tensioning protocol of the elastic bandage will work with 20% of the elastic deformation capacity of the bandage. The tension will be given from point A to point B in order to generate excitatory stimuli. The percentage of 20% reduction in tension will be distributed over the 7 weeks of intervention, and the first week of the protocol included application without tension. The tape reduction will be controlled by the formula: (size of the application area on the skin*20% /7 weeks= size of the tape to be cut in each of the 7 applications starting from the second week. Tape size and tape application area will be calculated in centimeters (cm). Receives: Device: Adhesive elastic bandage |
| Free tension | Placebo comparator | The group will have no tension in any of its tape applications; that way the size of the tape over the applied area will always be the same. Receives: Device: Adhesive elastic bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength of the rectus femoris muscle after 8 weeks of application of the elastic bandage
The dynamometer must be properly calibrated and the evaluation will be carried out with the participant seated and stabilized in the chair with a hip flexion of 85°, with a belt positioned horizontally in the pelvic region and two crossed belts in front of the trunk, in the thoracic region, while another belt will stabilize the thigh of the lower limb contralateral to the evaluated limb. The equipment's rotation axis must be aligned parallel to the axis of the evaluated knee joint (lateral epicondyle), and the lower limb will be fixed to the dynamometer lever arm, with the support pad two centimeters from the heel. The participant will have a brief familiarization with the equipment. They will have visual feedback on the monitor screen. 4 evaluation moments: 2 initial (without elastic bandage; and with elastic bandage, but without tension applied to the elastic bandage); 2 final (without elastic bandage; and with elastic bandage-with or without tension, according to the randomization)
Measured: Initial evaluation will be followed by 8 weeks of intervention with the use of elastic bandage and in the last week the reevaluation will be carried out.
Secondary outcomes (1)
Changes in activation of the rectus femoris muscle (surface electromyography) after 8 weeks of intervention with elastic bandage
The skin must be free of hair and clean with a cotton soaked in 70% alcohol to decrease the impedance of the area, preparing it for the placement of the electrodes. The electrodes will be positioned bilaterally in relation to the orientation of the muscle fibers of the rectus femoris muscle. The EMG signal will be captured with 2 bipolar electrodes and filtered through a bandpass between 25 and 450Hz with a sampling frequency of 2000Hz. With a low frequency filter of 20Hz, a high frequency filter of 1,000Hz and a common mode rejection rate of more than 110dB. The reference electrode will be positioned in the spinous process of the vertebral level C7. Normalization of EMG = Maximum Voluntary Isometric Contraction. 4 evaluation moments: 2 initial (without elastic bandage; and with elastic bandage, but without tension applied to the elastic bandage); 2 final (without elastic bandage; and with elastic bandage-with or without tension, according to the randomization).
Measured: Initial evaluation will be followed by 8 weeks of intervention with the use of elastic bandage and in the last week the reevaluation will be carried out.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The muscle strength of the right knee flexors and extensors will be verified using the isokinetic dynamometer and the muscular activation of the right knee extensors (rectus femoris muscle) will be assessed using surface electromyography. The elastic bandage will be applied over the muscular belly of the right rectus femoris muscle. Initially, all participants will be evaluated without tape, immediately receiving it without tension and, after 20 minutes of rest, they will be reassessed. All will be randomized into two groups and both will receive adhesive tape with or without tension in the application. In the eighth and last week, before the last application of the tape, everyone will be reevaluated without the tape. Then, the last application of the adhesive tape will be carried out with or without tension (according to their respective groups) and after 20 minutes of rest, everyone will be evaluated again with the last application of the tape.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodrigo Antonio Carvalho Andraus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodrigo Antonio Carvalho Andraus, Universidade Norte do Paraná
- Investigators
- Marieli R Stocco, PhD Student, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888520
- Sponsor's protocol ID
- 3.059.113: Projeto Marieli
- Status last verified
- Apr 2021
- First submitted
- 6 Jan 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no need for a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength and Muscle Activation of Runners Quadriceps After Eight Weeks of Intervention With Elastic Bandage - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04888520
- Acronym / sponsor ID
- 3.059.113: Projeto Marieli
- Conditions
- Muscle Strength
- Keywords
- Muscle strength, Peak Torque, Electromyography, Athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Rodrigo Antonio Carvalho AndrausUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a controlled and randomized clinical trial with the objective of verifying the acute and chronic effects (8 weeks) of elastic banding in runners. Thus, we have as hypotheses of this research: The elastic bandage indirectly influences the muscular strength to the extent that it supposedly can alter the muscular activation verified through the surface electromyography in individuals submitted to the training as the running training. The elastic bandage has clinical significance, however, it does not present statistical significance on muscle strength and activation in individuals submitted to training as running training. To confirm these hypotheses, the muscle strength of the flexors and extensors of the right knee will be checked by means of the isokinetic dynamometer and the muscular activation of the extensors of the right knee (rectus femoris muscle) will be assessed by means of surface electromyography. The elastic bandage will be applied according to a specific protocol in "I" over the muscular belly of the right femoral rectus muscle (which will be submitted to evaluations). All participants will be evaluated without applying adhesive tape and will receive the first application of the tape without tension. Then, after 20 minutes of rest, they will be reassessed with the tape. Participants will be randomized into two groups and both will receive the adhesive tape (with or without tension according to randomization). Then the evaluations will be repeated (all will be reevaluated without the tape and with the tape (with or without tension according to the protocol).
Detailed description
It is a controlled and randomized clinical trial in order to verify the acute and chronic effects (8 weeks of application) of the elastic bandage in runners. hus, we have as hypotheses of this research: The elastic bandage indirectly influences the muscular strength to the extent that it supposedly can alter the muscular activation verified through the surface electromyography in individuals submitted to the training as the running training. The elastic bandage has clinical significance, however, it does not present statistical significance on muscle strength and activation in individuals submitted to training as running training. To confirm these hypotheses, the muscle strength of the flexors and extensors of the right knee will be checked by means of the isokinetic dynamometer and the muscular activation of the extensors of the right knee (rectus femoris muscle) will be assessed by means of surface electromyography. The elastic bandage will be applied according to a specific protocol in "I" over the muscular belly of the right femoral rectus muscle (which will be submitted to evaluations). Initially all participants will be evaluated without applying adhesive tape and, in sequence, they will receive the first application of the tape (for all participants, the tape will be applied without tension) and after 20 minutes of rest, they will be reassessed with the application of the adhesive tape . After the initial assessment, participants will be randomized into two groups and both will receive adhesive tape. The FT (free tension) group will have no tension in any of its tape applications; and the WT (with tension) group will have progressive tension over 8 weeks of intervention (with reduction of the tape length over the weeks, in relation to the same size of the applied area, which generates a longitudinal tension of the tape in relation to skin of the participant). In the eighth and last week of intervention, before the last application of the tape, everyone will be evaluated again (strength and muscle activation) without the tape. Then, the last application of the tape will be performed with or without tension (according to their respective groups) and after 20 minutes of rest, the evaluation of all participants will be performed again with the last application of the tape to the rectus femoris muscle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The muscle strength of the right knee flexors and extensors will be verified using the isokinetic dynamometer and the muscular activation of the right knee extensors (rectus femoris muscle) will be assessed using surface electromyography. The elastic bandage will be applied over the muscular belly of the right rectus femoris muscle. Initially, all participants will be evaluated without tape, immediately receiving it without tension and, after 20 minutes of rest, they will be reassessed. All will be randomized into two groups and both will receive adhesive tape with or without tension in the application. In the eighth and last week, before the last application of the tape, everyone will be reevaluated without the tape. Then, the last application of the adhesive tape will be carried out with or without tension (according to their respective groups) and after 20 minutes of rest, everyone will be evaluated again with the last application of the tape.
| Arm | Type | Receives |
|---|---|---|
| Tensioning protocol of the elastic bandage (WT) | Experimental | Device: Adhesive elastic bandageThe group will have progressive tension throughout the week - based on the reduction of the tape in relation to the size of the applied area (which will always be the same), which generates a longitudinal tension of the tape in relation to the participant's skin. The Therapy Tex® brand has the elastic deformation capability of up to 40%. The tensioning protocol of the elastic bandage will work with 20% of the elastic deformation capacity of the bandage. The tension will be given from point A to point B in order to generate excitatory stimuli. The percentage of 20% reduction in tension will be distributed over the 7 weeks of intervention, and the first week of the protocol included application without tension. The tape reduction will be controlled by the formula: (size of the application area on the skin*20% /7 weeks= size of the tape to be cut in each of the 7 applications starting from the second week. Tape size and tape application area will be calculated in centimeters (cm). |
| Free tension | Placebo comparator | Device: Adhesive elastic bandageThe group will have no tension in any of its tape applications; that way the size of the tape over the applied area will always be the same. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- being between 18 and 60 years old;
- being physically able to participate in the experimental study;
- being completely independent in carrying out basic activities of daily living;
- not having a physical, hearing or visual impairment that prevents the exams from being performed or making use of prostheses or orthopedic orthoses;
- having no history of injury to the knee, ankle or hip;
Key exclusion criteria (2 listed)
- Participants who fail to complete evaluations and/or interventions for any reason
- Participants who, for some reason, decide to withdraw consent for the research will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhesive elastic bandageAlso: Kinesio Tape, Kinesio Taping, Kinesiotape, KinesiotapingThe base of the tape should be applied 5 cm below the origin of the rectus femoris (lower anterior iliac spine), going towards its insertion (base of the patella, through supra-patellar ligament), without tension in this part of the tape (2 to 3 cm initial) in order to avoid discomfort. The application mode will be in "I" ("I-strip"). The participants will be in the supine position, with the hip flexed at 30° and the knee flexed at 60°. The applications of the tape will be carried out every Monday, before the first day of running training of the week and should remain until Friday, when it will be removed by the researcher after the last day of running training of the week. If the elastic bandage unstuck alone from the skin before this period, the event should be immediately reported to the therapist. | Device | Free tension, Tensioning protocol of the elastic bandage (WT) |
Primary outcome
Change in muscle strength of the rectus femoris muscle after 8 weeks of application of the elastic bandage
Time frame: Initial evaluation will be followed by 8 weeks of intervention with the use of elastic bandage and in the last week the reevaluation will be carried out.
The dynamometer must be properly calibrated and the evaluation will be carried out with the participant seated and stabilized in the chair with a hip flexion of 85°, with a belt positioned horizontally in the pelvic region and two crossed belts in front of the trunk, in the thoracic region, while another belt will stabilize the thigh of the lower limb contralateral to the evaluated limb. The equipment's rotation axis must be aligned parallel to the axis of the evaluated knee joint (lateral epicondyle), and the lower limb will be fixed to the dynamometer lever arm, with the support pad two centimeters from the heel. The participant will have a brief familiarization with the equipment. They will have visual feedback on the monitor screen. 4 evaluation moments: 2 initial (without elastic bandage; and with elastic bandage, but without tension applied to the elastic bandage); 2 final (without elastic bandage; and with elastic bandage-with or without tension, according to the randomization)
1 secondary outcome
Changes in activation of the rectus femoris muscle (surface electromyography) after 8 weeks of intervention with elastic bandage
Time frame: Initial evaluation will be followed by 8 weeks of intervention with the use of elastic bandage and in the last week the reevaluation will be carried out.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: No. There is no need for a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marieli R Stocco, PhD Student principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Adhesive elastic bandage in people with Muscle Strength, run by Rodrigo Antonio Carvalho Andraus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marieli R Stocco, PhD Student (+55 43 9 9685 4812, stoccomarieli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle strength of the rectus femoris muscle after 8 weeks of application of the elastic bandage (time frame: Initial evaluation will be followed by 8 weeks of intervention with the use of elastic bandage and in the last week the reevaluation will be carried out.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.