Quality of LifeNCT05469191
Eight-week Effect of the Sit-to-stand Test on Muscle Architecture.
A study testing Group 5 STS and Group 10 STS in people with Quality of Life and Quality Muscle, run by Universidad de Granada at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Quality Muscle, Arquitecture Muscle
- What is being tested?
- Group 5 STS and Group 10 STS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 8 Aug 2022to 15 Feb 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Sit to Stand Test on Muscle Architecture After Eight Weeks.
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.
Read the detailed 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.
- Conditions
- Quality of Life, Quality Muscle, Arquitecture Muscle
- Being tested
- Group 5 STS, Group 10 STS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 5 STSOther
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 STSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 5 STS | Experimental | Group 5 STS will perform the same protocol as group 10 STS, only the number of repetitions between each set will change. Receives: Other: Group 5 STS |
| Group 10 STS | Experimental | Group 10 STS will perform the same protocol as group 5 STS, only the number of repetitions between each set will change. Receives: Other: Group 10 STS |
| Control group | No intervention | Control group, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before, 1 week completion of the intervention.
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.
Measured: Before, 1 week after completion of the intervention.
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.
Measured: Before, 1 week after completion of the intervention.
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.
Measured: Before, 1 week after completion of the intervention.
Secondary outcomes (1)
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]
Measured: Before, 1 week after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start8 Aug 2022
- Primary completion10 Dec 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A group that will perform the 5 STS will be compared with a group that will perform the 10 STS for 8 weeks, and there will also be a control group.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Lizama Perez, Universidad de Granada
- Investigators
- Rodrigo Lizama Pérez, M.Sc, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469191
- Sponsor's protocol ID
- IDAFISAD 64201
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Sit to Stand Test on Muscle Architecture After Eight Weeks.
- ClinicalTrials.gov ID
- NCT05469191
- Acronym / sponsor ID
- IDAFISAD 64201
- Conditions
- Quality of Life, Quality Muscle, Arquitecture Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 21 Jul 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A group that will perform the 5 STS will be compared with a group that will perform the 10 STS for 8 weeks, and there will also be a control group.
| Arm | Type | Receives |
|---|---|---|
| Group 5 STS | Experimental | Other: Group 5 STSGroup 5 STS will perform the same protocol as group 10 STS, only the number of repetitions between each set will change. |
| Group 10 STS | Experimental | Other: Group 10 STSGroup 10 STS will perform the same protocol as group 5 STS, only the number of repetitions between each set will change. |
| Control group | No intervention | –Control group, no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Group 5 STSFor 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. | Other | Group 5 STS |
| Group 10 STSFor 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. | Other | Group 10 STS |
Primary outcome
Change in the pennation angle of the vastus lateralis muscle.
Time frame: Before, 1 week completion of the intervention.
Calculated as the angle of insertion of the muscle fiber fascicles into the deep aponeurosis, measured with a linear probe in B-mode.
Change in the length of the fascicle of the vastus lateralis muscle
Time frame: Before, 1 week after completion of the intervention.
is calculated by measuring the length of the fascicular pathway between the superficial and deep aponeuroses,measured with a linear probe in B-mode.
Change in vastus lateralis muscle thickness
Time frame: Before, 1 week after completion of the intervention.
Muscle thickness will be determined as the distance between the superficial aponeurosis to the deep aponeurosis, measured with a linear probe in B-mode.
Change in muscle quality index (MQI)
Time frame: Before, 1 week after completion of the intervention.
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.
1 secondary outcome
Change in STS mean velocity (m· s-1), STS mean force (N), STS mean power (W), and STS relative power (W·Kg-1)
Time frame: Before, 1 week after completion of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Rodrigo Lizama Pérez, M.Sc principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 5 STS and Group 10 STS in people with Quality of Life and Quality Muscle, run by Universidad de Granada at 1 site in Chile.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the pennation angle of the vastus lateralis muscle. (time frame: Before, 1 week completion of the intervention.). The study lists 4 primary outcomes in all. 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 2 Mar 2023.