ACL ReconstructionKi-TASK-ACLRNCT07190456
Kinesiophobia vs. Task-Specific Fear: Defining Movement-Related Fear in ACL Reconstruction Patients
A study testing Exposure to neutral images visualization, Exposure to nocive images visualisation and Exposure to anticipated realisation of a feared movement in people with ACL Reconstruction, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 2 sites in Portugal.
Trial summary
Kinesiophobia, defined as an excessive and irrational fear of physical movement due to perceived vulnerability to injury, has gained significant attention in clinical and scientific communities. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- Exposure to neutral images visualization, Exposure to nocive images visualisation and Exposure to anticipated realisation of a feared movement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient must have given their informed consent and signed the consent form.
- The patient must have enough comprehension of the Portuguese language to complete the written questionnaires.
- The patient must have suffered an ACL injury, with or without a history of concomitant meniscal pathology, while playing or training for sport (recreational or organized).
- The patient must have undergone anterior cruciate ligament reconstruction surgery.
- The patient must be between 18 and 35 years old.
- The patient must still be under medical care/rehabilitation due to the ACL injury.
- The patient must have started jump landing tasks.
Who cannot join
- The subject has a history of repeated ACLR.
- The subject has not injured the ACL while playing sports.
- The subject presents a concurrent psychiatric disorder
- The subject has a history of heart disease and/or peripheral vascular disease and/or metabolic disease and/or Raynaud´s Syndrome.
- The subject is taking any medications known to affect heart rate or blood pressure
- The subject is currently a smoker.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites, 2 recruiting
- Recruiting
Egas Moniz School of Health & Science
Almada, Monte Da Caparica, 2829-699
João R. Vaz, PhD, 967096444 ext. +351, jvaz@egasmoniz.edu.pt
- Recruiting
Clínica de Fisioterapia Egas Moniz
Caparica, Almada, 2829/511
João R. Vaz, PhD, (+351) 21 294 68 80, jvaz@egasmoniz.edu.pt
Vanessa B. Alpalhão, Msc, +351 965844339, vanessaluisa@hotmail.com
About this study
Official title: Kinesiophophia or Task-specific Fear of Movement? What Are we Talking About in Patients Post Anterior Cruciate Ligament Reconstruction?
Kinesiophobia, defined as an excessive and irrational fear of physical movement due to perceived vulnerability to injury, has gained significant attention in clinical and scientific communities. This condition can act as a barrier to physical activity, negatively impacting patients' disability, quality of life, and the implementation of rehabilitation programs. It is particularly prevalent after anterior cruciate ligament reconstruction (ACLR), affecting physical function, return to sport rates, and patient performance.
While the Tampa Scale for Kinesiophobia (TSK) is considered a gold standard for assessing kinesiophobia, recent studies have raised concerns about its validity, especially in ACLR patients. The TSK may not adequately capture fear of specific sports activities, which is more common in ACLR patients than a general phobia of movement. Some researchers argue for an assessment approach similar to that used for pain experiences, emphasizing the subjective nature of fear.
Read more
Based on the specific phobia model, assessing kinesiophobia in the presence of a trigger, such as visualizing or confronting the movement associated with the injury, may be more relevant. This approach is supported by evidence showing that sports situations evoking the greatest fear after ACLR are cutting, jumping, and contact. Further research is needed to investigate alternative methodologies for assessing fear of movement in ACLR patients, considering the prevalence and repercussions of kinesiophobia in this population.
The objectives of this study are threefold:
- To compare the magnitude of kinesiophobia through the TSK, the subjective feeling of fear when visualising feared movements, and the subjective feeling of fear in anticipation of the feared situation.
- Evaluate the impact of focusing on feared activities on motor behavior and Autonomic Nervous System (ANS) markers.
- To assess the relation between the three methods of assessing fear of movement and indicators of motor behaviour, ANS activity, fear-avoidance beliefs, anxiety, avoidance behaviour, and physical function.
- Conditions
- ACL Reconstruction
- Being tested
- Exposure to neutral images visualization, Exposure to nocive images visualisation, Exposure to anticipated realisation of a feared movement
- Keywords
- Motor behavior, gait complexity, Autonomic Nervous System, Heart Rate Variability, Skin Conductance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to neutral images visualizationOther
The patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing neutral images (landscapes, monuments...)
Exposure to nocive images visualisationOther
The patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing images interpreted as nocive (cutting, jumping, contact...)
Exposure to anticipated realisation of a feared movementOther
Before the start of the experimental condition, the patient will be asked to think about their willingness to perform the first movement visualised in the video, while a researcher places a jumping platform inside the laboratory. During the test, the patient will have to walk on a treadmill at their preferred speed for 10 minutes, while watching a video showing a drop jump followed by images interpreted as nocive for the rest of the time.
| Study group | Role | What they receive |
|---|---|---|
| Neutral images | Sham comparator | The patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing neutral images (landscapes, monuments...) Receives: Other: Exposure to neutral images visualization |
| Nocive images | Experimental | The patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing images interpreted as nocive (cutting, jumping, contact...) Receives: Other: Exposure to nocive images visualisation |
| Antecipation feared movement | Experimental | Before the start of the experimental condition, the patient will be asked to think about their willingness to perform the first movement visualised in the video, while a researcher places a jumping platform inside the laboratory.
During the test, the patient will have to walk on a treadmill at their preferred speed for 10 minutes, while watching a video showing a drop jump followed by images interpreted as nocive for the rest of the time. Receives: Other: Exposure to anticipated realisation of a feared movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractal scaling exponent (α)
The fractal scaling exponent quantifies the complexity of a physiological signal and detects the presence of statistical persistence in a given time series. This parameter is calculated using Detrended Fluctuation Analysis (DFA) from each time series (stride time and stride length).
Measured: Day 0 (during intervention)
Heart rate variability
The R-R intervals will be derived from beat-to-beat blood pressure pulse intervals using finger plethysmography (Finapres® Nova, Amsterdam, Netherlands), at rest and during the gait trials. Finger plethysmography-derived peak-to-peak intervals are highly correlated with ECG R-R intervals, with similar variability. The upstroke is determined using the pressure signal with a resolution of 2 ms, and the interval between the two consecutive upstrokes is measured. In the frequency domain, the two primary components are low-frequency (LF; 0.04-0.15 Hz) and high-frequency (HF; 0.15-0.40 Hz) spectra. Heart rate variability measures provide information primarily on vagal modulation with the LF power spectrum reflecting both sympathetic and parasympathetic modulation and HF acting as a surrogate marker of parasympathetic modulation of the R-R intervals. The LF/HF ratio is used to indicate sympathovagal dominance.
Measured: Day 0 (during intervention)
Skin conductance
The skin conductance response (SCR) of the patients will be measured while they are exposed to the stimuli of the three experimental conditions. The SCR is an indicator of physiological arousal and is measured by detecting changes in the electrical conductance of the skin, which varies with the activity of the sweat glands. This assessment aims to understand the response of the patient's autonomic nervous system to the experimental conditions.
Measured: Day 0 (during intervention)
Blood pressure variability
Systolic and diastolic blood pressure values will be derived from beat-to-beat blood pressure recordings using finger plethysmography during all gait trials. Finger plethysmography-derived systolic and diastolic blood pressure signals are recorded with high precision and beat-to-beat variability in blood pressure is calculated with a resolution of 2 ms.
The variability is assessed by measuring the intervals between consecutive systolic upstrokes in the blood pressure waveform. BPV is analyzed by decomposing the signal into two primary components: low-frequency (LF; 0.04-0.15 Hz) and high-frequency (HF; 0.15-0.40 Hz) spectra. Blood pressure variability in the LF range reflects sympathetic modulation of vascular tone and arterial baroreflex sensitivity, while HF variability is often associated with respiratory influences and parasympathetic activity. The LF/HF ratio is used as an indicator of the balance between sympathetic and parasympathetic contributions to blood pressure regulation.
Measured: Day 0 (during intervention)
Secondary outcomes (7)
Physical Function in Sports and Leisure Activities subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS-Sport/Rec)
The KOOS is a self-reported measure that allows assessing a broad spectrum of subjects with knee injuries and OA, concerning pain and other symptoms, daily life function, sport and recreation, and knee-related quality of life. It consists of five sub-scales which are scored separately: pain (nine items); symptoms (seven items); function in ADL (17 items); Function in Sport and Recreation (five items); and Quality of Life (four items). The items are scored on a 5-point Likert scale ranging from 0 (no problems) to 4 (extreme problems). We will use the "Function in Sport and Leisure" subscale of the Portuguese version of the KOOS, for which total scores can range between 0 and 25 points, where zero represents extreme knee problems and 25 represents absence of knee problems.
Measured: Day 0 (Before experiment)
Physical Activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ-PA)
Fear-avoidance beliefs will be assessed using the Portuguese version of the FABQ. The original questionnaire was developed for subjects with chronic low back pain and consists of 16 items divided into two subscales, the FABQ-Physical Activity (FABQ-PA) and the FABQ-Work. The Portuguese version consists of 15 items, as item 8 ("I made a request for work compensation because of my pain") of the original scale was removed for being problematic. The subscale FABQ-PA of the Portuguese version consists of 5 items and the FABQ-work subscale consists of 10 items. In this study, we will use the FABQ-PA subscale specific to the knee, in which "back" will be replaced by "knee" as previously proposed in the literature. The 5 items of the FABQ-PA are scored on a 6-point Likert scale, except item 1 which is not quoted. The total score for the sub-scale can therefore range between 0 and 24 points. Higher scores on the FABQ indicate higher levels of fear-avoidance beliefs.
Measured: Day 0 (Before experiment)
Tampa Scale for Kinesiophobia 13 items version (TSK-13)
To assess kinesiophobia, the Portuguese version of the Tampa Scale for Kinesiophobia (TSK-PT), consisting of 13 items, will be used. The individual items are scored on a 4-point Likert scale (1 to 4), where 1 corresponds to "totally disagree" and 4 corresponds to "totally agree". The total score on the scale ranges between 13 and 52, with higher scores indicating higher levels of kinesiophobia.
Measured: Day 0 (Before experiment)
Hospital Anxiety and Depression Scale (HADS)
HADS is a screening instrument for anxiety and depression that helps to recognize the emotional components of physical illness. Structurally, it consists of two subscales, one assessing anxiety (HADS-A) and the other assessing depression (HADS-D). Each subscale contains 7 items, which are scored from 0 to 3 on a Likert scale. The total scores for each subscale range between 0 and 24 points.
We will use the HADS-A of the Portuguese version of the scale. The HADS-A contains items 1,3,5,7,9,11 and 13 of the scale, all of which score inversely except for items 7 and 9. According to the HADS manual a score between 0 and 7 is considered "normal", between 8 and 10 indicates "mild" anxiety, between 11 and 14 "moderate" and between 15 and 21 "severe" anxiety. Other authors propose a cut-off value of 8/9 points.
Measured: Day 0 (Before experiment)
Subjective feeling of fear (SFoM)
Numerical Rating Scale [0;100]
Measured: Day 0 : After walking with visualization of neutral images; after walking with visualization of feared movements; after walking with visualization of feared movement and in the anticipation of realizing a feared movement.
Avoidance behaviour related to specific feared activities
Participants will be asked to rate their agreement on a 0 to 100 numerical rating scale, with zero representing "totally disagree" and 100 representing "totally agree", with the following statement: "Because I am afraid of pain and/or re-injury I prefer to avoid jumping"
Measured: Day 0: after walking with visualization of feared movement and in anticipation of realizing a feared movement.
Coefficient of Variation (CV)
CV is a common linear measure that translates the amount of variability within the signal and is calculated through the standard deviation normalised to the mean from each time series (stride time and stride length).
Measured: Day 0 (during intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL ReconstructionStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190456
- Sponsor's protocol ID
- 1476
- Acronym
- Ki-TASK-ACLR
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2025
- Last updated
- 10 Sep 2026
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophophia or Task-specific Fear of Movement? What Are we Talking About in Patients Post Anterior Cruciate Ligament Reconstruction?
- ClinicalTrials.gov ID
- NCT07190456
- Acronym / sponsor ID
- Ki-TASK-ACLR / 1476
- Conditions
- ACL Reconstruction
- Keywords
- Motor behavior, gait complexity, Autonomic Nervous System, Heart Rate Variability, Skin Conductance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Sep 2025 (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.
Kinesiophobia, defined as an excessive and irrational fear of physical movement due to perceived vulnerability to injury, has gained significant attention in clinical and scientific communities. This condition can act as a barrier to physical activity, negatively impacting patients' disability, quality of life, and the implementation of rehabilitation programs. It is particularly prevalent after anterior cruciate ligament reconstruction (ACLR), affecting physical function, return to sport rates, and patient performance.
While the Tampa Scale for Kinesiophobia (TSK) is considered a gold standard for assessing kinesiophobia, recent studies have raised concerns about its validity, especially in ACLR patients. The TSK may not adequately capture fear of specific sports activities, which is more common in ACLR patients than a general phobia of movement. Some researchers argue for an assessment approach similar to that used for pain experiences, emphasizing the subjective nature of fear.
Based on the specific phobia model, assessing kinesiophobia in the presence of a trigger, such as visualizing or confronting the movement associated with the injury, may be more relevant. This approach is supported by evidence showing that sports situations evoking the greatest fear after ACLR are cutting, jumping, and contact. Further research is needed to investigate alternative methodologies for assessing fear of movement in ACLR patients, considering the prevalence and repercussions of kinesiophobia in this population.
The objectives of this study are threefold:
- To compare the magnitude of kinesiophobia through the TSK, the subjective feeling of fear when visualising feared movements, and the subjective feeling of fear in anticipation of the feared situation.
- Evaluate the impact of focusing on feared activities on motor behavior and Autonomic Nervous System (ANS) markers.
- To assess the relation between the three methods of assessing fear of movement and indicators of motor behaviour, ANS activity, fear-avoidance beliefs, anxiety, avoidance behaviour, and physical function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutral images | Sham comparator | Other: Exposure to neutral images visualizationThe patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing neutral images (landscapes, monuments...) |
| Nocive images | Experimental | Other: Exposure to nocive images visualisationThe patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing images interpreted as nocive (cutting, jumping, contact...) |
| Antecipation feared movement | Experimental | Other: Exposure to anticipated realisation of a feared movementBefore the start of the experimental condition, the patient will be asked to think about their willingness to perform the first movement visualised in the video, while a researcher places a jumping platform inside the laboratory. During the test, the patient will have to walk on a treadmill at their preferred speed for 10 minutes, while watching a video showing a drop jump followed by images interpreted as nocive for the rest of the time. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The patient must have given their informed consent and signed the consent form.
- The patient must have enough comprehension of the Portuguese language to complete the written questionnaires.
- The patient must have suffered an ACL injury, with or without a history of concomitant meniscal pathology, while playing or training for sport (recreational or organized).
- The patient must have undergone anterior cruciate ligament reconstruction surgery.
- The patient must be between 18 and 35 years old.
Key exclusion criteria (6 listed)
- The subject has a history of repeated ACLR.
- The subject has not injured the ACL while playing sports.
- The subject presents a concurrent psychiatric disorder
- The subject has a history of heart disease and/or peripheral vascular disease and/or metabolic disease and/or Raynaud´s Syndrome.
- The subject is taking any medications known to affect heart rate or blood pressure
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 |
|---|---|---|
| Exposure to neutral images visualizationThe patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing neutral images (landscapes, monuments...) | Other | Neutral images |
| Exposure to nocive images visualisationThe patient will have to walk on a treadmill at their preferential walking speed for 10 minutes while visualizing images interpreted as nocive (cutting, jumping, contact...) | Other | Nocive images |
| Exposure to anticipated realisation of a feared movementBefore the start of the experimental condition, the patient will be asked to think about their willingness to perform the first movement visualised in the video, while a researcher places a jumping platform inside the laboratory. During the test, the patient will have to walk on a treadmill at their preferred speed for 10 minutes, while watching a video showing a drop jump followed by images interpreted as nocive for the rest of the time. | Other | Antecipation feared movement |
Primary outcome
Fractal scaling exponent (α)
Time frame: Day 0 (during intervention)
The fractal scaling exponent quantifies the complexity of a physiological signal and detects the presence of statistical persistence in a given time series. This parameter is calculated using Detrended Fluctuation Analysis (DFA) from each time series (stride time and stride length).
Heart rate variability
Time frame: Day 0 (during intervention)
The R-R intervals will be derived from beat-to-beat blood pressure pulse intervals using finger plethysmography (Finapres® Nova, Amsterdam, Netherlands), at rest and during the gait trials. Finger plethysmography-derived peak-to-peak intervals are highly correlated with ECG R-R intervals, with similar variability. The upstroke is determined using the pressure signal with a resolution of 2 ms, and the interval between the two consecutive upstrokes is measured. In the frequency domain, the two primary components are low-frequency (LF; 0.04-0.15 Hz) and high-frequency (HF; 0.15-0.40 Hz) spectra. Heart rate variability measures provide information primarily on vagal modulation with the LF power spectrum reflecting both sympathetic and parasympathetic modulation and HF acting as a surrogate marker of parasympathetic modulation of the R-R intervals. The LF/HF ratio is used to indicate sympathovagal dominance.
Skin conductance
Time frame: Day 0 (during intervention)
The skin conductance response (SCR) of the patients will be measured while they are exposed to the stimuli of the three experimental conditions. The SCR is an indicator of physiological arousal and is measured by detecting changes in the electrical conductance of the skin, which varies with the activity of the sweat glands. This assessment aims to understand the response of the patient's autonomic nervous system to the experimental conditions.
Blood pressure variability
Time frame: Day 0 (during intervention)
Systolic and diastolic blood pressure values will be derived from beat-to-beat blood pressure recordings using finger plethysmography during all gait trials. Finger plethysmography-derived systolic and diastolic blood pressure signals are recorded with high precision and beat-to-beat variability in blood pressure is calculated with a resolution of 2 ms. The variability is assessed by measuring the intervals between consecutive systolic upstrokes in the blood pressure waveform. BPV is analyzed by decomposing the signal into two primary components: low-frequency (LF; 0.04-0.15 Hz) and high-frequency (HF; 0.15-0.40 Hz) spectra. Blood pressure variability in the LF range reflects sympathetic modulation of vascular tone and arterial baroreflex sensitivity, while HF variability is often associated with respiratory influences and parasympathetic activity. The LF/HF ratio is used as an indicator of the balance between sympathetic and parasympathetic contributions to blood pressure regulation.
7 secondary outcomes
Physical Function in Sports and Leisure Activities subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS-Sport/Rec)
Time frame: Day 0 (Before experiment)
Physical Activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ-PA)
Time frame: Day 0 (Before experiment)
Tampa Scale for Kinesiophobia 13 items version (TSK-13)
Time frame: Day 0 (Before experiment)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 0 (Before experiment)
Subjective feeling of fear (SFoM)
Time frame: Day 0 : After walking with visualization of neutral images; after walking with visualization of feared movements; after walking with visualization of feared movement and in the anticipation of realizing a feared movement.
Avoidance behaviour related to specific feared activities
Time frame: Day 0: after walking with visualization of feared movement and in anticipation of realizing a feared movement.
Coefficient of Variation (CV)
Time frame: Day 0 (during intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to neutral images visualization, Exposure to nocive images visualisation and Exposure to anticipated realisation of a feared movement in people with ACL Reconstruction, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 2 sites 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa B Alpalhão, MSc (965844339 ext. +351, vanessaluisa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractal scaling exponent (α) (time frame: Day 0 (during 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 10 Sep 2026.