HealthyNCT06331221
Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense
A study testing Muscle fatigue Protocol in people with Healthy, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Muscle fatigue Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Nov 2023to 15 May 2024
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- males aged between 18 and 30 years;
- without current or previous knee pathology or surgery;
- with a low or moderate physical activity level, according to the International Physical Activity Questionnaire;
- normal Body Mass Index (under 24.9 kg/m2), according to the World Health Organization.
Who cannot join
- those with cardiorespiratory, neurological or vestibular pathologies;
- with positive knee integrity tests (anterior drawer, Lachman's test, posterior drawer; valgus and varus stress testes); and
- those taking any medication that can affect motor control (sedatives, anxiolytics, antibiotics, analgesics, NSAIDs or myorelaxants).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense: a Randomized Controlled Crossover Trial
The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals.
Read the detailed description
A randomized controlled crossover trial will be conducted at a biomechanics laboratory with healthy males. All participants will perform with a washout period of 1 week: a control condition (5-minute rest) and 4 local muscle fatigue protocols (concentric of quadriceps; concentric of hamstrings; eccentric of quadriceps; eccentric of hamstrings) in an isokinetic dynamometer at 30º/s. Three maximum voluntary isometric contractions (MVIC) of quadriceps and hamstrings will also be assessed in the beginning of all conditions.
Knee joint position sense will be assessed before and immediately after the fatigue protocols/control condition, through active concentric and eccentric positionings/repositionings, in sitting and prone positions, to a target range of 45º of knee flexion in an isokinetic dynamometer. Surface electromyography electrodes will also be placed on the vastus lateralis and biceps femoris during all procedures.
- Conditions
- Healthy
- Being tested
- Muscle fatigue Protocol
- Keywords
- Muscle Fatigue, Knee, Joint Position Sense, Proprioception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle fatigue ProtocolOther
Four experimental conditions consisting of different local muscle fatigue protocols performed in the isokinetic dynamometer in random order, with at least one week of interval between them.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | 5-minute rest period. |
| Quadriceps_Concentric | Active comparator | 40 consecutive maximal concentric contractions of quadriceps at 30º/s Receives: Other: Muscle fatigue Protocol |
| Quadriceps_Eccentric | Active comparator | 40 consecutive maximal eccentric contractions of quadriceps at 30°/s Receives: Other: Muscle fatigue Protocol |
| Hamstrings_Concentric | Active comparator | 30 consecutive maximal concentric contractions of hamstrings at 30º/s Receives: Other: Muscle fatigue Protocol |
| Hamstrings_Eccentric | Active comparator | 30 consecutive maximal eccentric contractions of the hamstrings at 30º/s Receives: Other: Muscle fatigue Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute angular error
The absolute value of the difference between the target range and the achieved range
Measured: Change from Baseline (Before) to Immediately after interventions or control (After)
Relative angular error
The arithmetic difference between the target range and the range achieved
Measured: Change from Baseline (Before) to Immediately after interventions or control (After)
Variable angular error
The standard deviation of the 3 repositionings
Measured: Change from Baseline (Before) to Immediately after interventions or control (After)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start2 Nov 2023
- Primary completion5 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331221
- Sponsor's protocol ID
- JSA_Fatigue_FADEUP
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense: a Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT06331221
- Acronym / sponsor ID
- JSA_Fatigue_FADEUP
- Conditions
- Healthy
- Keywords
- Muscle Fatigue, Knee, Joint Position Sense, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 26 Mar 2024 (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.
The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals.
Detailed description
A randomized controlled crossover trial will be conducted at a biomechanics laboratory with healthy males. All participants will perform with a washout period of 1 week: a control condition (5-minute rest) and 4 local muscle fatigue protocols (concentric of quadriceps; concentric of hamstrings; eccentric of quadriceps; eccentric of hamstrings) in an isokinetic dynamometer at 30º/s. Three maximum voluntary isometric contractions (MVIC) of quadriceps and hamstrings will also be assessed in the beginning of all conditions.
Knee joint position sense will be assessed before and immediately after the fatigue protocols/control condition, through active concentric and eccentric positionings/repositionings, in sitting and prone positions, to a target range of 45º of knee flexion in an isokinetic dynamometer. Surface electromyography electrodes will also be placed on the vastus lateralis and biceps femoris during all procedures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –5-minute rest period. |
| Quadriceps_Concentric | Active comparator | Other: Muscle fatigue Protocol40 consecutive maximal concentric contractions of quadriceps at 30º/s |
| Quadriceps_Eccentric | Active comparator | Other: Muscle fatigue Protocol40 consecutive maximal eccentric contractions of quadriceps at 30°/s |
| Hamstrings_Concentric | Active comparator | Other: Muscle fatigue Protocol30 consecutive maximal concentric contractions of hamstrings at 30º/s |
| Hamstrings_Eccentric | Active comparator | Other: Muscle fatigue Protocol30 consecutive maximal eccentric contractions of the hamstrings at 30º/s |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- males aged between 18 and 30 years;
- without current or previous knee pathology or surgery;
- with a low or moderate physical activity level, according to the International Physical Activity Questionnaire;
- normal Body Mass Index (under 24.9 kg/m2), according to the World Health Organization.
Key exclusion criteria (3 listed)
- those with cardiorespiratory, neurological or vestibular pathologies;
- with positive knee integrity tests (anterior drawer, Lachman's test, posterior drawer; valgus and varus stress testes); and
- those taking any medication that can affect motor control (sedatives, anxiolytics, antibiotics, analgesics, NSAIDs or myorelaxants).
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 |
|---|---|---|
| Muscle fatigue ProtocolFour experimental conditions consisting of different local muscle fatigue protocols performed in the isokinetic dynamometer in random order, with at least one week of interval between them. | Other | Hamstrings_Concentric, Hamstrings_Eccentric, Quadriceps_Concentric, Quadriceps_Eccentric |
Primary outcome
Absolute angular error
Time frame: Change from Baseline (Before) to Immediately after interventions or control (After)
The absolute value of the difference between the target range and the achieved range
Relative angular error
Time frame: Change from Baseline (Before) to Immediately after interventions or control (After)
The arithmetic difference between the target range and the range achieved
Variable angular error
Time frame: Change from Baseline (Before) to Immediately after interventions or control (After)
The standard deviation of the 3 repositionings
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 11 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle fatigue Protocol in people with Healthy, run by Universidade do Porto at 1 site in Portugal.
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 3 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 11 Jul 2024. 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 Portugal. 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?
Absolute angular error (time frame: Change from Baseline (Before) to Immediately after interventions or control (After)). The study lists 3 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 11 Jul 2024.