Prefrail ElderlyNeuroFitNCT07346989
Non-invasive Brain Stimulation on Functional Capacity in Prefrail Older Adults
A study testing tDCS and Virtual running in people with Prefrail Elderly, run by University of Valencia at 1 site in Spain.
Trial summary
The general objective of this study is to evaluate the effectiveness of non-invasive neuromodulation combined with a therapeutic exercise program on neuroplasticity and, therefore, on variables related to functional capacity and quality of life, in prefrail older adults. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Prefrail Elderly
- What is being tested?
- tDCS and Virtual running
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2026to Jul 2028
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age between 65 -90 years old
- Meet 1-2 frailty criteria, according to Fried's Criteria.
- Ability to understand instructions (Mini-Mental State Examination >23 points).
- Signing of the informed consent.
Who cannot join
- History of stroke within the past 6 months or hospital admission for any reason within the past 3 months.
- Alterations of the central or peripheral nervous system
- Alterations of the vestibular system
- Concomitant diseases
- Have a neurological pathology, cardiovascular musculoskeletal that contraindicates physical activity
- Epilepsy or history, medications that lower the seizure threshold
Show all 14Show fewer
- Cardiac pacemaker, endocranial and hearing implants
- History of severe headaches
- Uncontrolled intracranial or arterial hypertension
- Heart and/or respiratory failure
- Implanted medication pump
- Skin lesions (psoriasis, eczema)
- Serious head surgeries
- Completing less than 80% of training sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia, Valencia, 46010
Marta Inglés de la Torre, PhD, marta.ingles@uv.es
About this study
Official title: Effectiveness of Non-invasive Brain Stimulation on Functional Capacity in Prefrail Older Adults
The general objective of this study is to evaluate the effectiveness of non-invasive neuromodulation combined with a therapeutic exercise program on neuroplasticity and, therefore, on variables related to functional capacity and quality of life, in prefrail older adults.
Read the detailed description
Two non-invasive neuromodulation strategies (Virtual Running and Transcranial Direct Current Stimulation (tDCS)) will be studied. Thus, 2 sub-studies will be carried out (one for each intervention) and a comparison of the two interventions will be made, as described in the following sections. As specific objectives, for each of these sub-studies, the effect of the intervention program will be analyzed on: gait speed, general physical condition, frailty condition, static and dynamic functionality and gait quality, upper limb and lower limb isometric strength, quality of life, and neuroplasticity, in terms of plasma BDNF levels, in prefrail older adults.
- Conditions
- Prefrail Elderly
- Being tested
- tDCS, tDCS placebo, Virtual running, Virtual running placebo
- Keywords
- Prefrail, Non-invasive neuromodulation, TDCS, Virtual running, Functional capacity, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
The tDCS will be performed anodically (a-tDCS), and for 24 sessions, 3 days a week. The electrodes will be mounted on a neoprene helmet, in accordance with the International Standard 10-20 EEG System, for optimal targeting of the primary motor cortex M1. It will be a type of unihemispheric application, in which the anode will be located in the primary motor cortex (M1), and the cathode located in the orbitofrontal cortex contralateral to the anode. The treatment parameters will be: stimulation time of 20 minutes; intensity of 2mA, current rise-fall time at the beginning and end of stimulation of 30 seconds. They will then perform the therapeutic exercise protocol explained above.
tDCS placeboOther
The instrumentation will be the same as in the actual tDCS intervention, but the device will be programmed to increase the intensity from 0 to 2 mA progressively during the first 30 seconds and then cease to provide the patient with the initial itchy sensation on the skin, similar to the real application. They will then perform the therapeutic exercise protocol explained above.
Virtual runningOther
24 sessions will be applied, 3 days a week. The patient will be placed standing (with an ad-hoc designed assistance system) in front of a mirror (located at waist height) and a height-adjustable screen (from waist to caudal) where a video of real legs running on a treadmill will be projected. In order for the participant to feel the projected legs as their own, people with different body sizes will have been previously recorded running to have recordings with legs of different size and length. Each session will last 20 minutes. They will then perform the therapeutic exercise protocol explained above.
Virtual running placeboOther
The instrumentation of the participants will be the same as in the intervention with virtual running. However, the projection will consist of a series of videos of landscapes in which no type of human or animal movement will appear in order not to stimulate the motor areas of the brain. They will then perform the therapeutic exercise protocol explained above.
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Experimental | Not described Receives: Other: tDCS |
| tDCS placebo group | Placebo comparator | Not described Receives: Other: tDCS placebo |
| VR group | Experimental | Not described Receives: Other: Virtual running |
| VR placebo group | Placebo comparator | Not described Receives: Other: Virtual running placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty Condition
Fried's criteria (Frailty Phenotype) will be used. Briefly, the participant will be considered frail if he or she meets three or more of the following criteria: i) unintentional weight loss greater than 4.5 kg in the last year; ii) feeling of general exhaustion, reported by the patient himself; iii) low level of physical activity; (iv) slowness of progress; v) muscle weakness, assessed by handgrip strength. Those patients who meet one or two criteria will be considered pre-frail and those who do not meet either will be considered non-frail
Measured: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Walking speed
The 10m Walking Test will be used to assess the speed of the walk, which records the time needed to cover the distance of 10m. The higher the walking speed, the greater the functional capacity
Measured: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Secondary outcomes (7)
Neuroplasticity
Neruoplasticity will be determined from the concentration of BDNF in plasma. A nurse will draw blood samples in BD Vacutainer® tubes, with EDTA as an anticoagulant. It will be centrifuged at 1500 G for 15 minutes at 4⁰ C, the supernatant (plasma) will be collected in eppendorf type tubes, which will be frozen at -80⁰ C until subsequent analysis. For the determination of BDNF levels, the ChemiKine™ BDNF Sandwich kit for ELISA (Millipore, Temecula, CA, USA) will be used, according to the manufacturer's instructions
Measured: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Heart rate variability
HRV will be measured during 5 minutes at rest before intervention and during 20 minutes while performing aerobic exercise (walking). HRV will be measured with the PolarH10 band (Polar ®, Finland).
Measured: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Muscle strength
Measurement of the isometric action of the lower limb muscles will be carried out by means of a load cell (Chronojump, Spain) connected to the corresponding software (Chronojump Boscosystem). Specifically, the isometric strength of the gluteus medius, quadriceps, and hamstrings will be measured. The participant will be asked for a maximum of three repetitions with a duration of five seconds each, and a rest between them of another thirty seconds. The maximum value will be recorded, as well as the average value of each of the three repetitions, and the average will then be obtained, which will be the variable used for the subsequent data analysis. As for upper limb strength, assessed by grip strength, this will be determined by a Lafayette hand dynamometer. 3 measurements of the dominant hand will be taken and the mean will be taken for further analysis. Higher values indicate greater muscle strength
Measured: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Quality of life EQ-5D
Determined using the EQ-5D instrument, a measure of self-perceived health, consisting of two parts: the EQ-5D descriptive system, which assesses five dimensions of health (i.e. mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analogue scale (VAS), in which people must estimate their general health status on a scale from 0 to 100. Higher values indicate greater quality of life.
Measured: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Lower limb muscle power
It will be recorded with the 5 times sit to stand test (5STST). The participant must sit down and get up from a chair and the time it takes to perform the activity is timed. The higher the speed, the greater lower limb power
Measured: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Static and dynamic functionality and gait quality
For this assessment, the FallSkip® tool will be used, which allows, by means of an inertial sensor incorporated in a smartphone, to record variables such as the medium-lateral and vertical displacement of the center of pressures in both dynamic and static, as well as to record the power to sit and get up from a chair and the variability of movement in a modified protocol of the Timed up and Go test. Based on the calculation of these variables, FallSkip® provides a fall risk score for each patient, ranging from very low, low, moderate, high, to very high risk, depending on the results obtained during the different test phases.
Measured: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Static and dynamic functionality and gait quality with a dual task
For this assessment, the FallSkip® tool will be used, which allows, by means of an inertial sensor incorporated in a smartphone, to record variables such as the medium-lateral and vertical displacement of the center of pressures in both dynamic and static, as well as to record the power to sit and get up from a chair and the variability of movement in a modified protocol of the Timed up and Go test. Based on the calculation of these variables, FallSkip® provides a fall risk score for each patient, ranging from very low, low, moderate, high, to very high risk, depending on the results obtained during the different test phases. For the dual task, a simultaneous activity will be used that will consist of numerical subtraction while walking. The higher punctuation, the better dual task functionality.
Measured: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Jan 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prefrail ElderlyStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Inglés de la Torre, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346989
- Sponsor's protocol ID
- 2025-FIS-4007899
- Acronym
- NeuroFit
- Status last verified
- Jun 2026
- First submitted
- 3 Dec 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared under request to the authors
Publications
Molla-Casanova S, Page A, Lopez-Pascual J, Ingles M, Sempere-Rubio N, Aguilar-Rodriguez M, Munoz-Gomez E, Serra-Ano P. Effects of mirror neuron activation therapies on functionality in older adults: Systematic review and meta-analysis. Geriatr Nurs. 2024 Mar-Apr;56:115-123. doi: 10.1016/j.gerinurse.2024.02.006. Epub 2024 Feb 11.
PubMed 38346365Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
PubMed 26180873Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Serra-Ano P, Munoz-Gomez E, Molla-Casanova S, Moreno-Segura N, Gonzalez-Pons H, Ingles M. Non-invasive brain stimulation on functional capacity in prefrail older adults: a protocol for a randomised clinical trial. Front Aging Neurosci. 2026 Aug 12;18:1891571. doi: 10.3389/fnagi.2026.1891571. eCollection 2026.
PubMed 42656613
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-invasive Brain Stimulation on Functional Capacity in Prefrail Older Adults
- ClinicalTrials.gov ID
- NCT07346989
- Acronym / sponsor ID
- NeuroFit / 2025-FIS-4007899
- Conditions
- Prefrail Elderly
- Keywords
- Prefrail, Non-invasive neuromodulation, TDCS, Virtual running, Functional capacity, Elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 16 Jan 2026 (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 general objective of this study is to evaluate the effectiveness of non-invasive neuromodulation combined with a therapeutic exercise program on neuroplasticity and, therefore, on variables related to functional capacity and quality of life, in prefrail older adults.
Detailed description
Two non-invasive neuromodulation strategies (Virtual Running and Transcranial Direct Current Stimulation (tDCS)) will be studied. Thus, 2 sub-studies will be carried out (one for each intervention) and a comparison of the two interventions will be made, as described in the following sections. As specific objectives, for each of these sub-studies, the effect of the intervention program will be analyzed on: gait speed, general physical condition, frailty condition, static and dynamic functionality and gait quality, upper limb and lower limb isometric strength, quality of life, and neuroplasticity, in terms of plasma BDNF levels, in prefrail older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Experimental | Other: tDCS |
| tDCS placebo group | Placebo comparator | Other: tDCS placebo |
| VR group | Experimental | Other: Virtual running |
| VR placebo group | Placebo comparator | Other: Virtual running placebo |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age between 65 -90 years old
- Meet 1-2 frailty criteria, according to Fried's Criteria.
- Ability to understand instructions (Mini-Mental State Examination >23 points).
- Signing of the informed consent.
Key exclusion criteria (14 listed)
- History of stroke within the past 6 months or hospital admission for any reason within the past 3 months.
- Alterations of the central or peripheral nervous system
- Alterations of the vestibular system
- Concomitant diseases
- Have a neurological pathology, cardiovascular musculoskeletal that contraindicates physical activity
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 |
|---|---|---|
| tDCSThe tDCS will be performed anodically (a-tDCS), and for 24 sessions, 3 days a week. The electrodes will be mounted on a neoprene helmet, in accordance with the International Standard 10-20 EEG System, for optimal targeting of the primary motor cortex M1. It will be a type of unihemispheric application, in which the anode will be located in the primary motor cortex (M1), and the cathode located in the orbitofrontal cortex contralateral to the anode. The treatment parameters will be: stimulation time of 20 minutes; intensity of 2mA, current rise-fall time at the beginning and end of stimulation of 30 seconds. They will then perform the therapeutic exercise protocol explained above. | Other | tDCS group |
| tDCS placeboThe instrumentation will be the same as in the actual tDCS intervention, but the device will be programmed to increase the intensity from 0 to 2 mA progressively during the first 30 seconds and then cease to provide the patient with the initial itchy sensation on the skin, similar to the real application. They will then perform the therapeutic exercise protocol explained above. | Other | tDCS placebo group |
| Virtual running24 sessions will be applied, 3 days a week. The patient will be placed standing (with an ad-hoc designed assistance system) in front of a mirror (located at waist height) and a height-adjustable screen (from waist to caudal) where a video of real legs running on a treadmill will be projected. In order for the participant to feel the projected legs as their own, people with different body sizes will have been previously recorded running to have recordings with legs of different size and length. Each session will last 20 minutes. They will then perform the therapeutic exercise protocol explained above. | Other | VR group |
| Virtual running placeboThe instrumentation of the participants will be the same as in the intervention with virtual running. However, the projection will consist of a series of videos of landscapes in which no type of human or animal movement will appear in order not to stimulate the motor areas of the brain. They will then perform the therapeutic exercise protocol explained above. | Other | VR placebo group |
Primary outcome
Frailty Condition
Time frame: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Fried's criteria (Frailty Phenotype) will be used. Briefly, the participant will be considered frail if he or she meets three or more of the following criteria: i) unintentional weight loss greater than 4.5 kg in the last year; ii) feeling of general exhaustion, reported by the patient himself; iii) low level of physical activity; (iv) slowness of progress; v) muscle weakness, assessed by handgrip strength. Those patients who meet one or two criteria will be considered pre-frail and those who do not meet either will be considered non-frail
Walking speed
Time frame: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
The 10m Walking Test will be used to assess the speed of the walk, which records the time needed to cover the distance of 10m. The higher the walking speed, the greater the functional capacity
7 secondary outcomes
Neuroplasticity
Time frame: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Heart rate variability
Time frame: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Muscle strength
Time frame: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Quality of life EQ-5D
Time frame: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Lower limb muscle power
Time frame: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Static and dynamic functionality and gait quality
Time frame: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
Static and dynamic functionality and gait quality with a dual task
Time frame: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).
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 6 Jul 2026.
- Background: PubMed 38346365Molla-Casanova S, Page A, Lopez-Pascual J, Ingles M, Sempere-Rubio N, Aguilar-Rodriguez M, Munoz-Gomez E, Serra-Ano P. Effects of mirror neuron activation therapies on functionality in older adults: Systematic review and meta-analysis. Geriatr Nurs. 2024 Mar-Apr;56:115-123. doi: 10.1016/j.gerinurse.2024.02.006. Epub 2024 Feb 11.
- Background: PubMed 26180873Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Derived from this study: PubMed 42656613Serra-Ano P, Munoz-Gomez E, Molla-Casanova S, Moreno-Segura N, Gonzalez-Pons H, Ingles M. Non-invasive brain stimulation on functional capacity in prefrail older adults: a protocol for a randomised clinical trial. Front Aging Neurosci. 2026 Aug 12;18:1891571. doi: 10.3389/fnagi.2026.1891571. eCollection 2026.
- Individual participant dataSharing planned: Undecided. IPD will be shared under request to the authors
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Virtual running in people with Prefrail Elderly, run by University of Valencia at 1 site in Spain.
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 14 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 6 Jul 2026. 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 Spain. 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 Marta Inglés de la Torre, PHD (0034963864003, marta.ingles@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Condition (time frame: Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07346989, which also lists 4 linked publications.
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 6 Jul 2026.