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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05469191
Other study ID # IDAFISAD 64201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2022
Est. completion date February 15, 2023

Study information

Verified date February 2023
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An 8-week intervention of the sit-to-stand test (STS) of 5 and 10 repetitions will be performed to two randomly selected groups to compare its effect on the muscle architecture of the vastus lateralis muscle. H1: 10 STS significantly modifies vastus lateralis muscle architecture in adults compared to 5STS and the control group.


Description:

Participants will be required to attend the laboratory for a first familiarization visit, where descriptive, biometric, and medical variables will also be evaluated. In addition, during this first familiarization session, it will be previously determined if the participants present any exclusion criteria and their muscle architecture will also be evaluated. After the familiarization session and the participants have signed the informed consent form, they will be randomly assigned to a 5 STS, 10 STS, or control group. Each group (exception of the control group) will be asked to perform three times a week one of the STS modalities assigned to them for 8 weeks, to ensure that the test is completed correctly and also to maintain the planning, the evaluator will be connected virtually with the participants, where rest times will be controlled and a fatigue perception scale will be performed at the end of each session, which will allow controlling the process each session. Subsequently, participants will be asked to attend the laboratory to re-evaluate their architectural parameters ( pennation angle, fascicle length, and muscle thickness) of the quadriceps muscle, one week after performing the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 15, 2023
Est. primary completion date December 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults, over 18 years of age. - They must have signed the informed consent form. - Who can perform the STS. - In case of suffering from a chronic non-communicable disease, that it is under control. Exclusion Criteria: - Inability to perform the STS. - Hypertension (>200/110 mmHg). - Acute neuromuscular or joint injury. - Who have suffered a stroke in the last 6 months. - Who have suffered a myocardial infarction or fracture in the last 6 months. - Terminally ill. - People who practice a sport professionally.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Group 5 STS
For 8 weeks, 3 times per week and 3 sets of 5 repetitions during the first month, then 5 sets of 5 repetitions during the second month. Between each repetition, there will be a rest of 30 to 60 seconds approximately.
Group 10 STS
For 8 weeks, 3 times per week and 3 sets of 10 repetitions during the first month, then 5 sets of 10 repetitions during the second month. Between each repetition, there will be a rest of 30 to 60 seconds approximately.

Locations

Country Name City State
Chile Universidad San Sebastián, sede Valdivia. Valdivia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the pennation angle of the vastus lateralis muscle. Calculated as the angle of insertion of the muscle fiber fascicles into the deep aponeurosis, measured with a linear probe in B-mode. Before, 1 week completion of the intervention.
Primary Change in the length of the fascicle of the vastus lateralis muscle is calculated by measuring the length of the fascicular pathway between the superficial and deep aponeuroses,measured with a linear probe in B-mode. Before, 1 week after completion of the intervention.
Primary Change in vastus lateralis muscle thickness Muscle thickness will be determined as the distance between the superficial aponeurosis to the deep aponeurosis, measured with a linear probe in B-mode. Before, 1 week after completion of the intervention.
Primary Change in muscle quality index (MQI) Was calculated using two different formulas: one proposed by Takai et al. And one by Fragala et al. The "Takai formula" considers the time required to perform ten repetitions of the sit-to-stand test, while the "Fragala formula" uses the time required for five repetitions: MQI = ((leg length x chair height) x body mass x gravity x 10/ Time STS). Both calculations consider the length of the leg in meters, the height of the chair used in the test, body mass in kilograms, acceleration due to gravity (9.81 m/s^2), and a fixed constant of 10. Before, 1 week after completion of the intervention.
Secondary Change in STS mean velocity (m· s-1), STS mean force (N), STS mean power (W), and STS relative power (W·Kg-1) The STS mean velocity (m· s-1), STS mean force (N), STS mean power (W), and STS relative power (W·Kg-1), were calculated with the formulas proposed by Alcazar et al. The formulas are as follows:
STS mean velocity = [0.5 x Height - Chair height] / Five STS time × 0.1]
STS mean force = 0.9 x g x Body mass
STS mean power = Body mass x 0.9 x g x [Height x 0.5 - Chair height / Five STS time × 0.1]
Relative STS mean power = 0.9 x g x Height [ 0.5 x Chair height] / Five STS time × 0.1]
Before, 1 week after completion of the intervention.
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