Frail Elderly SyndromeNCT03657940
Impact of a Multicomponent Exercise Program on Functional Capacity in Frail Aged Participants With Cognitive Decline
A study testing VIVIFRAIL multicomponent exercise training program in people with Frail Elderly Syndrome and Cognitive Impairment, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
Randomized Controlled trial of 370 aged participants over 75 years old coming from clinics of Geriatric Departments in three University Hospitals in Spain (Pamplona, Getafe y San Sebastián). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Cognitive Impairment
- What is being tested?
- VIVIFRAIL multicomponent exercise training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to Mar 2020
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- - Age: 75 years or older.
- Able to ambulate with or without personal/technical assistance.
- Barthel Index ≥ 60.
- Able to communicate.
- Mild cognitive impairment or Dementia level GDS-4.
- Fragility o pre-frailty according to Linda Fried ≥ 1.
- Subjects should have someone to help them do the exercises.
- Informed consent: Must be capable and willing to provide consent.
Who cannot join
- Any factor precluding performance of the physical training programme or testing procedures as determined by the attending physician. These factors include, but are not limited to the following:
- Myocardial infarction in the past 3 months.
- Unstable Angina pectoris.
- Terminal illness.
- Uncontrolled arrhythmia.
- Unstable cardiovascular disease or other medical condition.
- Uncontrolled arterial hypertension.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundación Miguel Servet/ Navarrabiomed
Pamplona, 31008
Fabricio Zambon, PhD, +(34) 848422287, fabriciogigante@hotmail.com
About this study
Official title: Impact of a Multicomponent Exercise Program (VIVIFRAIL)on Functional Capacity in Frail Community Aged Participants With Cognitive Decline . Multi-center Randomized Control Trial
Randomized Controlled trial of 370 aged participants over 75 years old coming from clinics of Geriatric Departments in three University Hospitals in Spain (Pamplona, Getafe y San Sebastián). Participants who met inclusion criteria will be randomized to control (usual care)l or intervention group (multicomponent exercise program). The main objective of the trial is to study the effect of a multicomponent exercise training program (resistance, aerobic, strength, balance and flexibility) in frail aged participants who live in the community with cognitive decline in: functional capacity, strength, power, cognition, falls , depression, quality of life, institutionalization and hospital admissions
Read the detailed description
Usual care group (control) Participants randomly assigned to the usual care group will receive normal outpatient care, which includes physical rehabilitation when needed.
Intervention group (training) The intervention will consist of a multicomponent exercise training programme -VIVIFRAIL-(A Practical Guide for Prescribing a Multi-Component Physical Training Program to prevent weakness and falls in People over 70, Showed in www.vivifrail.com), which will be composed of supervised progressive resistance training, balance-training, flexibility and cardiovascular for 7 days/week. During the training period, patients will be trained between 2 and 120 minutes each day.
The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1RM combined with balance-training, flexibility and gait exercises that progressed in difficulty. The resistance exercises focused on the major upper and lower limb muscles. During the progressive resistance training, instruction will be provided to the participants to perform the exercises at a high velocity of motion. However, care will be taken to ensure that exercises were executed with correct form. Balance and gait training exercises that progressed in difficulty will be also implemented: e.g. semitandem foot standing, line walking, stepping practice, walking with small obstacles, proprioceptive exercises, and altering the base of support and weight transfer from one leg to the other. An experienced physical trainer will carefully explain all the exercises. Participants and their carer / family members will be carefully familiarized with the training procedures in advance.
- Conditions
- Frail Elderly Syndrome, Cognitive Impairment
- Being tested
- VIVIFRAIL multicomponent exercise training program
- Keywords
- Exercise therapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVIFRAIL multicomponent exercise training programBehavioural
The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1Repetition Maximum ( combined with balance-training, flexibility and gait exercises that progressed in difficulty.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | multicomponent exercise training program [VIVIFRAIL], Receives: Behavioral: VIVIFRAIL multicomponent exercise training program |
| Usual Care | No intervention | Participants randomly assigned to the usual care group will receive normal outpatient care, which includes physical rehabilitation when needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB) which evaluates, balance, gait ability, and leg strength using a single tool. The total score ranges from 0 (worst) to 12 points (best). The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization, and mortality. A total score of less than 10 indicates frailty and a high risk of disability and falls. A one-point change in the score has clinical relevance
Measured: Changes from baseline to 1st and 3th months of follow up
Secondary outcomes (25)
Barthel index
international and validated tool of disability. The score range from 0 (severe functional dependence) to 100 (functional independence
Measured: Changes from baseline to 1st and 3th months of follow up
Handgrip strength in the dominant hand
Loss of handgrip strength in the dominant hand evaluated with a dynamometer is a useful tool for the measurement of functional capacity. This characteristic is a strong predictor of disability, morbidity, and mortality as well as one of the components of Fried's frailty phenotype. Higher values indicates better function Ranges of normality are corrected by BMI. For example for men with a BMI less of 24 , normality is consider over 29 kg
Measured: Changes from baseline to 1st and 3th months of follow up
6-metre gait velocity test (GVT).
Gait ability will be assessed using the 6-metre gait velocity test (GVT). Starting and ending limits will be marked on the floor with tapelines for a total distance of 8 meters. Participants will be instructed to walk in their self-selected usual pace for two attempts. The best result of both trials will be registered. The first and last metre, considered the warm-up and deceleration phases, respectively, will not be included in calculations of the gait assessment. Higher scores ( > 1.0 m/s) indicates better functional capacity and lower scores (< 0.8 m/s) scores worse functional capacity
Measured: Changes from baseline to 1st and 3th months of follow up
MEC-Lobo cognitive test
cognitive function will be measured will the Spanish Version of MMSE ( MEC-Lobo) in case of dementia. It ranges from 0 ( worse score ) to 35 (best score). A score less than 23 indicates significative cognitive decline
Measured: Changes form baseline to 1st and 3th months of follow up
MOCA( Montreal Cognitive Assessment) test
cognitive function will be measured with MOCA ( Montreal Cognitive Assessment Test) in case of mild cognitive decline. The MOCA is a validated test in Spanish It ranges from 0 ( worse score ) to 30 (best score). A score less than 26 indicates suggest mild cognitive decline
Measured: Changes from baseline to 1st and 3th months of follow up
Trail Making Test part A ( TMT-A)
Executive function will be assessed with the Trail Making Test part A. Results for TMT A are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.Average will be consider 29 seconds, Deficient > 78 seconds and Rule of Thumb most 90 seconds.
Measured: Changes from baseline to 1st and 3th months of follow up
Isometric lower limb strength test (right knee extensors and hip flexors)
Isometric lower limb (right knee extensors and hip flexors) muscle strength will be measured using a manual dynamometer. Higher values indicates better functional capacity
Measured: Changes from baseline to 1st and 3th months of follow up
1Repetition Maximum (RM) Maximal dynamic strength test
Maximal dynamic strength will be assessed using the 1Repetition Maximum (RM) test in the bilateral leg press exercise using exercise machines (Exercycle, S.L., BH Group, Vitoria, Spain). In the first assessment, the subjects will warm up with specific movements for the exercise test. Each subject's maximal load will be determined in no more than five attempts, with a 3-min recovery period between attempts.
Measured: Changes from baseline to 1st and 3th months of follow up
Repetitions at maximal velocity at intensities of 50% of 1RM test
Participants will perform ten repetitions at maximal velocity at intensities of 50% of 1RM to determine the maximum power (w) and the loss of power during the ten repetitions in the leg press exercise.Higher values indicates better functional capacity
Measured: Changes from baseline to 1st and 3th months of follow up
Geriatric Depression Scale ( GDS) Yesavage abbreviated scale
Depression will be assessed wit the GDS Yesavage abbreviated scale of 15 items. Is is ranged between 0 ( best value) to 15 ( worse value). Scores between 0-5 indicates normality, 5-9 minor depression and scores over 9 indicates mayor depression
Measured: Changes from baseline to 1st and 3th months of follow up
Categorical pain scale
Pain will be assessed with a subjective categorical pain scale. It is ranged in four categories : 0 ( no pain), 4 ( litle bit), 6 ( quite) , 10 ( a lot)
Measured: Changes from baseline to and 3th months of follow up
Rate of falls
Rate of new falls during follow up
Measured: Baseline, 1st and 3th months of follow up
Vivifrail risk of falls scale
Risk of falls will be assessed using Vivifrail methodology. High risk of falls is considered if one of the following questions is positive: 2 o more falls in the last year, a previous fall with medical attention and if the participant scores over 20 seconds in the time up and go test, TUG test ( time of rising from a chair, walking three meters and going back to sitting position) or less than 0.8 m/s in the Gait velocity test
Measured: Changes from baseline to 1st and 3th months of follow up
Mortality
Mortality will be assessed with a clinical questionnaire during follow up.
Measured: Changes from baseline to 1st and 3th months of follow up
Admissions to the hospital
New admissions to the hospital will be assessed with a clinical questionnaire during follow up
Measured: Baseline, 1st and 3th months of follow up
Incidence of institutionalization to nursing homes
New institutionalizations to nursing homes will be assessed with clinical questionary during follow up
Measured: Baseline, 1st and 3th months of follow up
Visit to emergency room
Visits to emergency room will be assessed with a clinical questionnaire during follow up
Measured: Baseline, 1st and 3th months of follow up
Number of total Drugs
Number of drugs during follow up will be assessed with a clinical questionnaire
Measured: Changes from baseline to 3th month´s follow up
Presence of 5 or more drugs ( Polypharmacy ) registration
Registration of the presence of 5 or more drugs( Polypharmacy ) during follow -up will be done with a clinical questionnaire .
Measured: Changes from baseline to 3th month´s follow up
Psychotropic drugs (neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics) registration
Registration of the following physchotropic drugs will be assessed with a clinical questionnaire : neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics
Measured: Changes from baseline to 3th month´s follow up
Neuropsychiatric Inventory Questionary (NPI)
Assessment of psycho-behavioral symptoms associated to mild cognitive decline or dementia will be assessed with the Neuropsychiatric Inventory Questionary (NPI). NPI is a validated informant-based interview that assesses 12 neuropsychiatric symptoms over the previous month.Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them (i.e. Caregiver distress) using a 5-point scale. The NPI provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores.
Measured: Changes from baseline and 3th month´s follow up
Dual task gait ( arithmetic) 6 m velocity test
The dual-task paradigm will be used in the 6-m habitual GVT. Two trials will be conducted (best record will be taking in account) During the arithmetic dual-task condition (arithmetic GVT), we will assess gait velocity while participants are counting backward aloud from 100 by ones
Measured: Changes from baseline to 1st and 3th months of follow up
Dual task gait (verbal) 6 m velocity test
The dual-task paradigm will be used in the 6-m habitual GVT. Two trials will be conducted(best record will be taking in account)During the verbal dual-task condition (verbal GVT), we will assess gait velocity while participants are naming animals by loud
Measured: Changes from baseline to 1st and 3th months of follow up
EuroQol-5D (EQ-5D) quality of life assessment test
Quality of of life will be assessed with an international validated scale EuroQol-5D (EQ-5D). Its composed by. It asses health status (mobility, personal care, basic and instrumental daily living activities , pain and ansiety/depression) ranged from 0 ( worst health status) to 100 ( best health status )
Measured: Changes from baseline to 3th month´s follow up
Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )
Presence of other geriatric syndromes ( visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers ) will be assessed with a clinical questionnaire
Measured: Changes from baseline to 3th month´s follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Sep 2017
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Matia Foundation, Hospital Universitario Getafe
- Responsible party
- Sponsor
- Investigators
- Alvaro Casas Herrero, MD PhD, Principal investigator, Complejo Hospitalario de Navarra/Fundación Navarrabiomed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657940
- Sponsor's protocol ID
- Gov NA 28-16
- Status last verified
- Sep 2018
- First submitted
- 30 Jul 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.
PubMed 35150086Casas-Herrero A, Anton-Rodrigo I, Zambom-Ferraresi F, Saez de Asteasu ML, Martinez-Velilla N, Elexpuru-Estomba J, Marin-Epelde I, Ramon-Espinoza F, Petidier-Torregrosa R, Sanchez-Sanchez JL, Ibanez B, Izquierdo M. Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial. Trials. 2019 Jun 17;20(1):362. doi: 10.1186/s13063-019-3426-0.
PubMed 31208471
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multicomponent Exercise Program (VIVIFRAIL)on Functional Capacity in Frail Community Aged Participants With Cognitive Decline . Multi-center Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03657940
- Acronym / sponsor ID
- Gov NA 28-16
- Conditions
- Frail Elderly Syndrome, Cognitive Impairment
- Keywords
- Exercise therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Matia Foundation, Hospital Universitario Getafe
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 5 Sep 2018 (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.
Randomized Controlled trial of 370 aged participants over 75 years old coming from clinics of Geriatric Departments in three University Hospitals in Spain (Pamplona, Getafe y San Sebastián). Participants who met inclusion criteria will be randomized to control (usual care)l or intervention group (multicomponent exercise program). The main objective of the trial is to study the effect of a multicomponent exercise training program (resistance, aerobic, strength, balance and flexibility) in frail aged participants who live in the community with cognitive decline in: functional capacity, strength, power, cognition, falls , depression, quality of life, institutionalization and hospital admissions
Detailed description
Usual care group (control) Participants randomly assigned to the usual care group will receive normal outpatient care, which includes physical rehabilitation when needed.
Intervention group (training) The intervention will consist of a multicomponent exercise training programme -VIVIFRAIL-(A Practical Guide for Prescribing a Multi-Component Physical Training Program to prevent weakness and falls in People over 70, Showed in www.vivifrail.com), which will be composed of supervised progressive resistance training, balance-training, flexibility and cardiovascular for 7 days/week. During the training period, patients will be trained between 2 and 120 minutes each day.
The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1RM combined with balance-training, flexibility and gait exercises that progressed in difficulty. The resistance exercises focused on the major upper and lower limb muscles. During the progressive resistance training, instruction will be provided to the participants to perform the exercises at a high velocity of motion. However, care will be taken to ensure that exercises were executed with correct form. Balance and gait training exercises that progressed in difficulty will be also implemented: e.g. semitandem foot standing, line walking, stepping practice, walking with small obstacles, proprioceptive exercises, and altering the base of support and weight transfer from one leg to the other. An experienced physical trainer will carefully explain all the exercises. Participants and their carer / family members will be carefully familiarized with the training procedures in advance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: VIVIFRAIL multicomponent exercise training programmulticomponent exercise training program [VIVIFRAIL], |
| Usual Care | No intervention | –Participants randomly assigned to the usual care group will receive normal outpatient care, which includes physical rehabilitation when needed. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- - Age: 75 years or older.
- Able to ambulate with or without personal/technical assistance.
- Barthel Index ≥ 60.
- Able to communicate.
- Mild cognitive impairment or Dementia level GDS-4.
Key exclusion criteria (7 listed)
- Any factor precluding performance of the physical training programme or testing procedures as determined by the attending physician. These factors include, but are not limited to the following:
- Myocardial infarction in the past 3 months.
- Unstable Angina pectoris.
- Terminal illness.
- Uncontrolled arrhythmia.
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 training programThe supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1Repetition Maximum ( combined with balance-training, flexibility and gait exercises that progressed in difficulty. | Behavioural | Exercise intervention |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: Changes from baseline to 1st and 3th months of follow up
The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB) which evaluates, balance, gait ability, and leg strength using a single tool. The total score ranges from 0 (worst) to 12 points (best). The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization, and mortality. A total score of less than 10 indicates frailty and a high risk of disability and falls. A one-point change in the score has clinical relevance
25 secondary outcomes
Barthel index
Time frame: Changes from baseline to 1st and 3th months of follow up
Handgrip strength in the dominant hand
Time frame: Changes from baseline to 1st and 3th months of follow up
6-metre gait velocity test (GVT).
Time frame: Changes from baseline to 1st and 3th months of follow up
MEC-Lobo cognitive test
Time frame: Changes form baseline to 1st and 3th months of follow up
MOCA( Montreal Cognitive Assessment) test
Time frame: Changes from baseline to 1st and 3th months of follow up
Trail Making Test part A ( TMT-A)
Time frame: Changes from baseline to 1st and 3th months of follow up
Isometric lower limb strength test (right knee extensors and hip flexors)
Time frame: Changes from baseline to 1st and 3th months of follow up
1Repetition Maximum (RM) Maximal dynamic strength test
Time frame: Changes from baseline to 1st and 3th months of follow up
Repetitions at maximal velocity at intensities of 50% of 1RM test
Time frame: Changes from baseline to 1st and 3th months of follow up
Geriatric Depression Scale ( GDS) Yesavage abbreviated scale
Time frame: Changes from baseline to 1st and 3th months of follow up
Categorical pain scale
Time frame: Changes from baseline to and 3th months of follow up
Rate of falls
Time frame: Baseline, 1st and 3th months of follow up
Vivifrail risk of falls scale
Time frame: Changes from baseline to 1st and 3th months of follow up
Mortality
Time frame: Changes from baseline to 1st and 3th months of follow up
Admissions to the hospital
Time frame: Baseline, 1st and 3th months of follow up
Incidence of institutionalization to nursing homes
Time frame: Baseline, 1st and 3th months of follow up
Visit to emergency room
Time frame: Baseline, 1st and 3th months of follow up
Number of total Drugs
Time frame: Changes from baseline to 3th month´s follow up
Presence of 5 or more drugs ( Polypharmacy ) registration
Time frame: Changes from baseline to 3th month´s follow up
Psychotropic drugs (neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics) registration
Time frame: Changes from baseline to 3th month´s follow up
Neuropsychiatric Inventory Questionary (NPI)
Time frame: Changes from baseline and 3th month´s follow up
Dual task gait ( arithmetic) 6 m velocity test
Time frame: Changes from baseline to 1st and 3th months of follow up
Dual task gait (verbal) 6 m velocity test
Time frame: Changes from baseline to 1st and 3th months of follow up
EuroQol-5D (EQ-5D) quality of life assessment test
Time frame: Changes from baseline to 3th month´s follow up
Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )
Time frame: Changes from baseline to 3th month´s follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 35150086Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.
- Derived from this study: PubMed 31208471Casas-Herrero A, Anton-Rodrigo I, Zambom-Ferraresi F, Saez de Asteasu ML, Martinez-Velilla N, Elexpuru-Estomba J, Marin-Epelde I, Ramon-Espinoza F, Petidier-Torregrosa R, Sanchez-Sanchez JL, Ibanez B, Izquierdo M. Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial. Trials. 2019 Jun 17;20(1):362. doi: 10.1186/s13063-019-3426-0.
- 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.
Alvaro Casas Herrero, MD PhD principal investigator
Complejo Hospitalario de Navarra/Fundación Navarrabiomed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVIFRAIL multicomponent exercise training program in people with Frail Elderly Syndrome and Cognitive Impairment, run by Fundacion Miguel Servet 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 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. 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. 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 Alvaro Casas Herrero, MD PhD (+(34) 848422287 ext. 21007, alvaro.casas.herrero@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: Changes from baseline to 1st and 3th months of follow up). 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 NCT03657940, which also lists 2 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 5 Sep 2018.