Strength and Muscle Activation of Runners Quadriceps After 8 Weeks of Intervention With Elastic Bandage

NCT ID: NCT04888520

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-09-15

Brief 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 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.

Conditions

Muscle Strength

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Tensioning protocol of the elastic bandage (WT)

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).

Group Type: EXPERIMENTAL

Adhesive elastic bandage

Intervention Type: DEVICE

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.

Free tension

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.

Group Type: PLACEBO_COMPARATOR

Adhesive elastic bandage

Intervention Type: DEVICE

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.

Interventions

Adhesive elastic bandage

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.

Intervention Type: DEVICE

Other Intervention Names

Kinesio Tape; Kinesio Taping; Kinesiotape; Kinesiotaping; Functional elastic bandage

Eligibility Criteria

Inclusion Criteria

1. being between 18 and 60 years old;

2. being physically able to participate in the experimental study;

3. being completely independent in carrying out basic activities of daily living;

4. not having a physical, hearing or visual impairment that prevents the exams from being performed or making use of prostheses or orthopedic orthoses;

5. having no history of injury to the knee, ankle or hip;

6. has no allergy to elastic bandages;

7. having time to participate in the interventions;

8. has no cognitive impairment according to the Mini Mental State Examination (MMSE);

9. has a training frequency of at least twice a week for more than three months.

Exclusion Criteria

1. Participants who fail to complete evaluations and/or interventions for any reason

2. Participants who, for some reason, decide to withdraw consent for the research will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rodrigo Antonio Carvalho Andraus

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Antonio Carvalho Andraus

Coordinator of Stricto Sensu Program in Rehabilitation Sciences

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marieli R Stocco, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Marieli R Stocco, PhD Student

Role: CONTACT

stoccomarieli@gmail.com

+55 43 9 9685 4812

Rodrigo Antonio C Andraus, PhD

Role: CONTACT

rodrigo.andraus@unopar.com.br

+55 43 9 8611 6665

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

3.059.113: Projeto Marieli

Identifier Type: -

Identifier Source: org_study_id