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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04888520
Other study ID # 3.059.113: Projeto Marieli
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date September 15, 2021

Study information

Verified date April 2021
Source Universidade Norte do Paraná
Contact Marieli R Stocco, PhD Student
Phone +55 43 9 9685 4812
Email stoccomarieli@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date September 15, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rodrigo Antonio Carvalho Andraus

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 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 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). 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.
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