Healthy AgeingNCT05744492
Multicomponent Exercise Program on the Intrinsic Capacity (ICOPE) of Community-dwelling Older Adults in Primary Care
A study testing Vivifrail multicomponent exercise program in people with Healthy Ageing, run by European University Spain.
Trial summary
A three-branch multi-center randomized clinical trial to be conducted in 6 public Primary Care centers located in the city of Madrid (Spain). A total of 180 older adults (>=70 years old) presenting with declines in the intrinsic capacity (IC) locomotion domain will be recruited in the participating centers. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Ageing
- What is being tested?
- Vivifrail multicomponent exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 2025
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥70 years old
- Attending participating primary care centers
- Pre-frailty or frailty according to Fried's criteria
- SPPB <10
- Barthel Index Score ≥60
- Being able to communicate and ambulate with or without technical aids
- Relative/caregiver willingness to supervise the exercise (if needed)
Who cannot join
- Major cognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V criteria or the Global Deterioration Scale by Reisberg (GDS>4)
- Physically active individuals (moderate-to-vigorous physical activity greater than 150 minutes per week according current physical activity guidelines for older adults) or those already participating in structured physical exercise programs
- Diagnosis of a terminal illness/life expectancy ≤3months
- Lack of possibility of follow-up
- Institutionalized or awaiting institutionalization
- Any contraindications for physical exercise or testing procedures, including but not limited to: myocardial infarction in the past 6 months; unstable angina pectoris; uncontrolled arrhythmia; unstable cardiovascular disease or other unstable medical condition; uncontrolled arterial hypertension; recent pulmonary thromboembolism; upper or lower extremity fracture in the past 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of a Multicomponent Exercise Program on the Intrinsic Capacity of Community-dwelling Older Adults Under the ICOPE Framework: Study Protocol for a Multi-center Randomized Control Trial in Primary Care
A three-branch multi-center randomized clinical trial to be conducted in 6 public Primary Care centers located in the city of Madrid (Spain). A total of 180 older adults (>=70 years old) presenting with declines in the intrinsic capacity (IC) locomotion domain will be recruited in the participating centers. They will be randomized in a 1:1:1 ratio to a center-based supervised Vivifrail multicomponent exercise (MCE) program, a home-based non-supervised Vivifrail MCE program, or to a control group. The intervention consists of thrice-a-week exercise sessions encompassing strength, aerobic, flexibility, and balance and gait training tailored to the individual's baseline functional ability. IC will be assessed through its operational domains following ICOPE guidelines at baseline and 6 and 12 weeks after the start of the intervention. Secondarily, effects on frailty status and health-related quality of life will be evaluated.
This study might bring new evidence around the ICOPE recommendation on the Vivifrail MCE for the management of IC locomotion declines in Primary Care for the first time. Gaining insight on exercise interventions for IC promotion/maintenance will reinforce current recommendations and contribute to the development of real-world strategies for healthy aging promotion.
- Conditions
- Healthy Ageing
- Being tested
- Vivifrail multicomponent exercise program
- Keywords
- Frail Older Adults, Elderly, Primary care, Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivifrail multicomponent exercise programOther
Resistance: 3 sets of 2 repetitions of 3-4 exercises with a 1 to 3-minute break between sets. Intensity from 30-repetition maximum (RM) at weeks 1-6 to 20-RM at weeks 7-12.
Balance training: both static and dynamic. Subjects will increase the number of repetitions, the difficulty of the exercises or will add external perturbations to the tasks (unstable surfaces, obstacles, or visual deprivation) along the duration of the interventions to guaranteeing progression. In the case of high risk of falling the number, frequency and volume of balance exercises will be increased.
Flexibility: a set of stretching exercises at the end of each session. Subjects will be instructed to stretch until they feel tension in their muscles without reaching discomfort. Stretching will be maintained for 10 sec. and repeated 2-3 times.
Cardiovascular: walking-based activities oriented to increase cardiorespiratory fitness. They will range from 5-10 sec. to 45 min/session.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Vivifrail (S-ViF) | Experimental | A 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Once-per-week, subjects assigned to this group will attend the primary care center to execute one of the three exercise sessions per week under the supervision of the physical therapist. Receives: Other: Vivifrail multicomponent exercise program |
| Non-supervised Vivifrail Group (NS-ViF) | Experimental | A 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Subjects assigned to this group will follow a domiciliary-based program and they will not attend the primary care center to execute the exercises. Receives: Other: Vivifrail multicomponent exercise program |
| Control group (UCG) | No intervention | Subjects will receive usual care following prevention protocols of Primary Care Services in Madrid. Concisely, the benefits of physical activity are individually explained and subjects are advised to walk as much as possible with the aim of reaching at least 30 minutes a day, 5 days a week, following the recommendations of the World Health Organization. No structured exercise-based interventions are programmed in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 12-weeks in the Short Physical Performance Battery (SPPB) score
Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)
Measured: From baseline (T0) to 12-weeks (T2)
Change from baseline to 6-weeks in the Short Physical Performance Battery (SPPB) score
Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)
Measured: From baseline (T0) to 6-weeks (T1)
Change from 12-weeks to 24-weeks in the Short Physical Performance Battery (SPPB) score
Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)
Measured: From 12-weeks (T2) to 24-weeks (T3)
Secondary outcomes (18)
Change from baseline to 12-weeks in the Montreal Cognitive Assessment (MoCA) score
Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best)
Measured: From baseline (T0) to 12-weeks (T2)
Change from baseline to 6-weeks in the Montreal Cognitive Assessment (MoCA) score
Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best)
Measured: From baseline (T0) to 6-weeks (T1)
Change from 12 to 24-weeks in the Montreal Cognitive Assessment (MoCA) score
Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best)
Measured: From 12-weeks (T2) to 24-weeks (T3)
Change from baseline to 12-weeks in the Geriatric Depression Scale (GDS-15)
Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse)
Measured: From baseline (T0) to 12-weeks (T2)
Change from baseline to 6-weeks in the Geriatric Depression Scale (GDS-15)
Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse)
Measured: From baseline (T0) to 6-weeks (T1)
Change from 12-weeks to 24-weeks in the Geriatric Depression Scale (GDS-15)
Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse)
Measured: From 12 weeks (T2) to 24-weeks (T3)
Change from baseline (T0) to 12-weeks (T2) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best)
Measured: From baseline (T0) to 12-weeks (T2)
Change from baseline (T0) to 6-weeks (T1) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best)
Measured: From baseline (T0) to 6-weeks (T1)
Change from 12-weeks (T2) to 24-weeks (T3) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best)
Measured: From 12-weeks (T2) to 24-weeks (T3)
Change in the isometric handgrip strength from baseline (T0) to 12-weeks (T2)
Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer
Measured: From baseline (T0) to 12-weeks (T2)
Change in the isometric handgrip strength from baseline (T0) to 6-weeks (T1)
Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer
Measured: From baseline (T0) to 6-weeks (T1)
Change in the isometric handgrip strength from 12-weeks (T2) to 24-weeks (T3)
Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer
Measured: From 12-weeks (T2) to 24-weeks (T3)
Change in visual capacity from baseline (T0) to 12-weeks (T2)
Distance and near vision assessed with WHO simple eye charts
Measured: From baseline (T0) to 12-weeks (T2)
Change in visual capacity from baseline (T0) to 6-weeks (T1)
Distance and near vision assessed with WHO simple eye charts
Measured: From baseline (T0) to 6-weeks (T1)
Change in visual capacity from 12-weeks (T2) to 24-weeks (T3)
Distance and near vision assessed with WHO simple eye charts
Measured: From 12-weeks (T2) to 24-weeks (T3)
Change in hearing capacity from baseline (T0) to 12-weeks (T2)
HearWHO App consisting of an automated digit-in-noise test
Measured: From baseline (T0) to 12-weeks (T2)
Change in hearing capacity from baseline (T0) to 6-weeks (T1)
HearWHO App consisting of an automated digit-in-noise test
Measured: From baseline (T0) to 6-weeks (T1)
Change in hearing capacity from 12-weeks (T2) to 24-weeks (T3)
HearWHO App consisting of an automated digit-in-noise test
Measured: From 12-weeks (T2) to 24-weeks (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgeingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-branch multi-center randomized clinical trial with 1:1:1 allocation to a center-based supervised Vivifrail MCE, a home-based non-supervised Vivifrail MCE program, or to a control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Service of Madrid
- Responsible party
- Principal investigator, Maria-Jose Gimenez Mestre, European University Spain
- Investigators
- Maria-Jose Gimenez, PhD, Principal investigator, European University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744492
- Sponsor's protocol ID
- 22/574
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
PubMed 10811152
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Exercise Program on the Intrinsic Capacity of Community-dwelling Older Adults Under the ICOPE Framework: Study Protocol for a Multi-center Randomized Control Trial in Primary Care
- ClinicalTrials.gov ID
- NCT05744492
- Acronym / sponsor ID
- 22/574
- Conditions
- Healthy Ageing
- Keywords
- Frail Older Adults, Elderly, Primary care, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- European University SpainUniversity, hospital or other
- Collaborators
- Public Health Service of Madrid
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 27 Feb 2023 (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.
A three-branch multi-center randomized clinical trial to be conducted in 6 public Primary Care centers located in the city of Madrid (Spain). A total of 180 older adults (>=70 years old) presenting with declines in the intrinsic capacity (IC) locomotion domain will be recruited in the participating centers. They will be randomized in a 1:1:1 ratio to a center-based supervised Vivifrail multicomponent exercise (MCE) program, a home-based non-supervised Vivifrail MCE program, or to a control group. The intervention consists of thrice-a-week exercise sessions encompassing strength, aerobic, flexibility, and balance and gait training tailored to the individual's baseline functional ability. IC will be assessed through its operational domains following ICOPE guidelines at baseline and 6 and 12 weeks after the start of the intervention. Secondarily, effects on frailty status and health-related quality of life will be evaluated.
This study might bring new evidence around the ICOPE recommendation on the Vivifrail MCE for the management of IC locomotion declines in Primary Care for the first time. Gaining insight on exercise interventions for IC promotion/maintenance will reinforce current recommendations and contribute to the development of real-world strategies for healthy aging promotion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-branch multi-center randomized clinical trial with 1:1:1 allocation to a center-based supervised Vivifrail MCE, a home-based non-supervised Vivifrail MCE program, or to a control group.
| Arm | Type | Receives |
|---|---|---|
| Supervised Vivifrail (S-ViF) | Experimental | Other: Vivifrail multicomponent exercise programA 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Once-per-week, subjects assigned to this group will attend the primary care center to execute one of the three exercise sessions per week under the supervision of the physical therapist. |
| Non-supervised Vivifrail Group (NS-ViF) | Experimental | Other: Vivifrail multicomponent exercise programA 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Subjects assigned to this group will follow a domiciliary-based program and they will not attend the primary care center to execute the exercises. |
| Control group (UCG) | No intervention | –Subjects will receive usual care following prevention protocols of Primary Care Services in Madrid. Concisely, the benefits of physical activity are individually explained and subjects are advised to walk as much as possible with the aim of reaching at least 30 minutes a day, 5 days a week, following the recommendations of the World Health Organization. No structured exercise-based interventions are programmed in this group. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥70 years old
- Attending participating primary care centers
- Pre-frailty or frailty according to Fried's criteria
- SPPB <10
- Barthel Index Score ≥60
Key exclusion criteria (6 listed)
- Major cognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V criteria or the Global Deterioration Scale by Reisberg (GDS>4)
- Physically active individuals (moderate-to-vigorous physical activity greater than 150 minutes per week according current physical activity guidelines for older adults) or those already participating in structured physical exercise programs
- Diagnosis of a terminal illness/life expectancy ≤3months
- Lack of possibility of follow-up
- Institutionalized or awaiting institutionalization
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 |
|---|---|---|
| Vivifrail multicomponent exercise programResistance: 3 sets of 2 repetitions of 3-4 exercises with a 1 to 3-minute break between sets. Intensity from 30-repetition maximum (RM) at weeks 1-6 to 20-RM at weeks 7-12. Balance training: both static and dynamic. Subjects will increase the number of repetitions, the difficulty of the exercises or will add external perturbations to the tasks (unstable surfaces, obstacles, or visual deprivation) along the duration of the interventions to guaranteeing progression. In the case of high risk of falling the number, frequency and volume of balance exercises will be increased. Flexibility: a set of stretching exercises at the end of each session. Subjects will be instructed to stretch until they feel tension in their muscles without reaching discomfort. Stretching will be maintained for 10 sec. and repeated 2-3 times. Cardiovascular: walking-based activities oriented to increase cardiorespiratory fitness. They will range from 5-10 sec. to 45 min/session. | Other | Non-supervised Vivifrail Group (NS-ViF), Supervised Vivifrail (S-ViF) |
Primary outcome
Change from baseline to 12-weeks in the Short Physical Performance Battery (SPPB) score
Time frame: From baseline (T0) to 12-weeks (T2)
Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)
Change from baseline to 6-weeks in the Short Physical Performance Battery (SPPB) score
Time frame: From baseline (T0) to 6-weeks (T1)
Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)
Change from 12-weeks to 24-weeks in the Short Physical Performance Battery (SPPB) score
Time frame: From 12-weeks (T2) to 24-weeks (T3)
Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)
18 secondary outcomes
Change from baseline to 12-weeks in the Montreal Cognitive Assessment (MoCA) score
Time frame: From baseline (T0) to 12-weeks (T2)
Change from baseline to 6-weeks in the Montreal Cognitive Assessment (MoCA) score
Time frame: From baseline (T0) to 6-weeks (T1)
Change from 12 to 24-weeks in the Montreal Cognitive Assessment (MoCA) score
Time frame: From 12-weeks (T2) to 24-weeks (T3)
Change from baseline to 12-weeks in the Geriatric Depression Scale (GDS-15)
Time frame: From baseline (T0) to 12-weeks (T2)
Change from baseline to 6-weeks in the Geriatric Depression Scale (GDS-15)
Time frame: From baseline (T0) to 6-weeks (T1)
Change from 12-weeks to 24-weeks in the Geriatric Depression Scale (GDS-15)
Time frame: From 12 weeks (T2) to 24-weeks (T3)
Change from baseline (T0) to 12-weeks (T2) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
Time frame: From baseline (T0) to 12-weeks (T2)
Change from baseline (T0) to 6-weeks (T1) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
Time frame: From baseline (T0) to 6-weeks (T1)
Change from 12-weeks (T2) to 24-weeks (T3) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
Time frame: From 12-weeks (T2) to 24-weeks (T3)
Change in the isometric handgrip strength from baseline (T0) to 12-weeks (T2)
Time frame: From baseline (T0) to 12-weeks (T2)
Change in the isometric handgrip strength from baseline (T0) to 6-weeks (T1)
Time frame: From baseline (T0) to 6-weeks (T1)
Change in the isometric handgrip strength from 12-weeks (T2) to 24-weeks (T3)
Time frame: From 12-weeks (T2) to 24-weeks (T3)
Change in visual capacity from baseline (T0) to 12-weeks (T2)
Time frame: From baseline (T0) to 12-weeks (T2)
Change in visual capacity from baseline (T0) to 6-weeks (T1)
Time frame: From baseline (T0) to 6-weeks (T1)
Change in visual capacity from 12-weeks (T2) to 24-weeks (T3)
Time frame: From 12-weeks (T2) to 24-weeks (T3)
Change in hearing capacity from baseline (T0) to 12-weeks (T2)
Time frame: From baseline (T0) to 12-weeks (T2)
Change in hearing capacity from baseline (T0) to 6-weeks (T1)
Time frame: From baseline (T0) to 6-weeks (T1)
Change in hearing capacity from 12-weeks (T2) to 24-weeks (T3)
Time frame: From 12-weeks (T2) to 24-weeks (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Background: PubMed 10811152Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
- The Vivifrail multicomponent exercise program - Home pageLink provided by the sponsor.
- 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.
Maria-Jose Gimenez, PhD principal investigator
European University
Questions about this trial
What is this clinical trial studying?
A study testing Vivifrail multicomponent exercise program in people with Healthy Ageing, run by European University 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 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: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria-Jose Gimenez, PhD (+34629174335, mariajose.gimenez@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 12-weeks in the Short Physical Performance Battery (SPPB) score (time frame: From baseline (T0) to 12-weeks (T2)). 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?
On the ClinicalTrials.gov record for NCT05744492, which also lists 1 linked publication.
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 28 Feb 2023.