FallVivifrailcognNCT04911179
Combined Exercise and Cognitive Stimulation for Falls Prevention
A study testing Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation. in people with Fall and Frailty, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
Randomized clinical trial of 310 older adults over 75 years old recruited from the Falls Units of Geriatric Departments in 4 three University Hospitals in Spain (Pamplona, San Sebastián, Albacete and Barcelona). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Fall, Frailty, Cognition Disorders in Old Age
- What is being tested?
- Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 75 years or older
- Referral to the Falls Unit
- Ability to ambulate independently with or without technical aids
- Barthel Index ≥ 60
- Pre-frailty (1-2 criteria) or Frailty according to the Frailty Phenotype by Fried et al
- Risk of falling according to following criteria:
Show all 11Show fewer
- Gait disorders captured through physical performance measures (Time Up and Go Test ≥ 20 s and/or Gait Speed ≥0,8 m/s
- ≥2 self-reported falls in the previous year
- ≥1 self-reported falls requiring medical assistance
- Relative/caregiver willingness to supervise the exercise/cognitive stimulation sessions
- Capability and willingness to provide informed consent
Who cannot join
- Unwillingness to either complete the study requirements or to be randomized into the control or the intervention group
- Life expectancy ≤ 3 months
- Terminal illness
- No possibility of follow-up
- Institutionalization or awaiting institutionalization
- Major cognitive impairment DSM-V moderate or severe (CDR 2-3 /GDS 5-7)
Show all 16Show fewer
- No ability to read and write
- Severe visual and hearing deficit
- Any contraindications for physical exercise or testing procedures, including but not limited to:
- myocardial infarction in the past 3 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
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario de Navarra. Department of Geriatrics
Pamplona, Navarre, 31008
Älvaro Casas Herrero, MD PhD, 0034848422287 ext. 21007, alvaro.casas.herrero@navarra.es
Álvaro Casas Herrero, MD PhD
About this study
Official title: Effect of an Individualized Combined Intervention (Vivifrail-Cogn) on the Rate of Falling of Frail Older Adults at Risk of Falling Living in the Community: a Multicenter Randomized Clinical Trial.
Randomized clinical trial of 310 older adults over 75 years old recruited from the Falls Units of Geriatric Departments in 4 three University Hospitals in Spain (Pamplona, San Sebastián, Albacete and Barcelona). Participants who met inclusion criteria will be randomized to the usual care group (Otago exercise program) or the Vivifrail-Cog Intervention (a combination of physical exercise Vivifrail program and cognitive training). The main objective of the present randomized clinical trial is to investigate the effect of the combined intervention (exercise and cognitive intervention) in frail older participants living in the community and at risk of falling. The main endpoint will be the rate of falling in the following year. Secondary endpoints include physical performance, muscle strength, cognitive performance, hospitalizations, institutionalization, depression and quality of life.
Read the detailed description
Usual care: subjects randomized to the usual care group will receive an evidence-based multidisciplinary intervention tailored at reducing the fall risk (polypharmacy, environmental intervention, physical exercise). Importantly, the Otago exercise program (considered the standard physical exercise intervention) will be prescribed in this group.
Intervention group: subjects assigned to this intervention will engage in a multicomponent intervention combining an exercise program, Vivifrail (A practical guide for prescribing a Multicomponent Physical Training Program to prevent weakness and falls in people over 70, more information at www.vivifrail.com) and a cognitive training. Vivifrail exercise program combines resistance, endurance, balance and flexibility exercise tailored to the functional level of the subjects, guaranteeing an individualized approach. Exercises progress in terms of intensity and difficulty as the subject adapts to exercise. The cognitive stimulation program combines exercises to work on different cognitive functions, mainly addressing executive functions (attentional system, processing speed, perceptual organization, working memory and cognitive flexibility, verbal comprehension, abstraction and reasoning, planning, execution and problem solving ).
It lasts 12 weeks, two weekly sessions. It is divided into 4 levels in order to adapt the intervention to participant's individual capacity, and the level can be adjusted throughout the intervention.
Correct execution will be monitored by constant contact with relatives in charge of supervising the exercise program, who will be familiarized with the intervention prior to participation.
- Conditions
- Fall, Frailty, Cognition Disorders in Old Age, Exercise, Cognitive Change
- Being tested
- Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.
- Keywords
- Fall, Frailty, Cognition Disorders in Old Age, Exercise, Cognitive Change
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.Other
The areas to be worked on are: Attentional system: selective attention and concentration; alternating attention / dual attention; Processing speed; perceptual organization; working memory and cognitive flexibility; comprehension, abstraction and verbal reasoning, planning, execution, and problem solving.
Four programs have been developed stimulation different difficulty levels to adapt to the capabilities of each participant.
| Study group | Role | What they receive |
|---|---|---|
| Combined multicomponent physical exercise and cognitive stimulation (Vivfrail-Cog) | Experimental | The supervised multicomponent exercise training program (resistance, endurance, balance and flexibility) will be comprised of upper and lower body exercises tailored to the individual's functional capacity. Subjects will be encouraged at performing strength and endurance exercise at a moderate intensity. Exercise will progress in terms of intensity and difficulty upon individual adaptation.
The cognitive intervention will include the performance of different exercises with pencil and paper in order to train different cognitive areas, especially the executive functions. Receives: Other: Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation. |
| Usual care | No intervention | The usual care group will receive normal outpatient care (including the evidence-based Otago exercise program). |
What is being measured
The primary outcome is the main question the study is designed to answer.
One year falls rate
Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.Subjects will be contacted by phone in a monthly basis after completing the 3-months lasting intervention and inform the research team about the incidence of falls.
Measured: during one year
One year fall-related hospitalizations
Number of fall-related hospitalizations
Measured: during one year
One year fall-related fracture
Number of fall-related fracture (radiologically confirmed)
Measured: during one year
One year fall-related death
Number of fall-related death
Measured: during one year
Secondary outcomes (26)
Barthel
Barthel Index changes from baseline to 6-week, 12-week and 24-week and 1-year
Measured: At baseline, 6-week, 12-week and 24-week and 1-year.
Garvan Fracture Risk
Changes from baseline to 12-week The Fracture Risk Calculator was developed using data collected in the internationally renowned Dubbo Osteoporosis Epidemiology Study conducted by the Bone and Mineral Research Program of Sydney's Garvan Institute of Medical Research. It estimates the 5-year and 10-year risk of hip and any fracture based on information on sex, age, number of fractures since the age of 50, the rate of falling and the bone mineral density.
Measured: At baseline and 12-week
Handgrip Strength in both hands
Changes from baseline to 6-week and 12-week.Handgrip strength will be measured by using a dynamometer (JAMAR) in both dominant and non-dominant hand. Best performance of two trials will be registered.
Measured: At baseline, 6-week, 12-week
4-metre gait velocity test (GVT)
Changes from baseline to 6 week and 3 months.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: At baseline, 6 week and 3 months.
Short Physical Performance Battery (SPPB)
Changes from baseline to 1 and 3 months. 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: At baseline,1 and 3 months.
Fried's Frailty Phenotype (FP)
Changes from baseline to 3 months. The Fried's Frailty Phenotype (FP) consists of five items: weight loss, exhaustion, strength, physical activity and gait speed. For grip strength, 3-m GS and Physical Activity Scale for the Elderly (PASE) scores. Subjects are classified as robust if not meeting any criteria, pre-frail if they met 1-2 of the criteria and frail if ≥3 were present.
Measured: At baseline and 3 months
SARC-F (Screening of Sarcopenia Among Older Adults)
Changes from baseline to 1 and 3 months. The SARC-F is a screening scale to ascertain the risk of sarcopenia (the presence of age-associated low muscle mass and function). It is composed of 5 items related to the presence of difficulty in loading weights, walking, standing-up from a chair, climbing stairs and the number of falls in the previous year. A score greater than 4 is indicative of the presence of sarcopenia.
Measured: At baseline,1 and 3 months.
Musculoskeletal echography
Changes from baseline to 6-week and 3 months. Muscle thickness and quality will be assessed through musculoskeletal echography, a non-intrusive imaging method. Muscle thickness and quality (infiltration of non-contractile tissue) will be measured in the rectus femoris (region from sub-cutaneous tissue to the bone surface).
Measured: At baseline, 6 weeks and 3 months
MOCA (Montreal Cognitive Assessment) test
Changes from baseline to 6-week and 3 months. 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: At baseline, 6 weeks and 3 months
Trail Making Test part A ( TMT-A)
Changes from baseline to 6-week and 3 months. 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: At baseline, 6 weeks and 3 months
Falls-related psychological consequences
Changes from baseline, 12-week visit; and 24-week and 1-year. Fear of falling will be evaluated through three questions: ''Are you afraid of falling?'', ''Do you limit any house-hold activities because you are frightened you may fall?'', ''Do you limit any outside activities because you are frightened you may fall?''.
FES-I was developed as part of the Prevention of Falls Network Europe (ProFaNE) project from 2003 to 2006, following an intensive review of fear of falling, self-efficacy and balance confidence questionnaires. It ascertains the impact that fear of falling has on 16 activities of daily living. Scores range from 16 to 64 and classify the fear of falling as low (16-19), moderate (20-27) and high (28-64) concern.
Measured: At baseline, 12 week, 24 week and 1 year.
1-Repetition Maximum (RM) Maximal dynamic strength test
Changes from baseline to 6-week and 3 months. 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: At baseline, 6 weeks and 3 months
Repetitions at maximal velocity at intensities of 50% of 1RM test
Changes from baseline to 6-week and 3 months. 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 indicate better functional capacity
Measured: At baseline, 6 weeks and 3 months
Geriatric Depression Scale (GDS) Yesavage abbreviated scale
Changes from baseline to 6-week and 3 months. 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: At baseline, 6 weeks and 3 months
Mortality
Mortality will be assessed with a clinical questionnaire during follow up
Measured: At baseline, 6 weeks and 3 months
Admissions to the hospital
New admissions to the hospital will be assessed with a clinical questionnaire during follow up
Measured: At baseline, 6 weeks and 3 months
Incidence of institutionalization to nursing homes
New institutionalizations to nursing homes will be assessed with clinical questionary during follow up
Measured: At baseline, 6 weeks and 3 months
Visit to emergency room
Visits to emergency room will be assessed with a clinical questionnaire during follow up
Measured: At baseline, 6 weeks and 3 months
Number of total Drugs
Number of drugs during follow up will be assessed with a clinical questionnaire
Measured: At baseline and 3 months
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: At baseline and 3 months
Psychotropic and hypotensive drugs registration
Registration of the presence of psychotropic and hypotensive drugs during follow -up will be done with a clinical questionnaire
Measured: At baseline and 3 months
Drug Burden Index
It is a pharmacological measure of an individual's exposure to medications with anticholinergic and sedative effects. DBI is calculated for an individual by summing the burdens from every anticholinergic or sedative medicine they take regularly. A calculator available in https://www.anticholinergicscales.es/ will be used.
Measured: At baseline, 3, 6, 9 and 12 months
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: At baseline, week 6 and 3 months
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: At baseline, 6-week and 3 months
EuroQol-5D (EQ-5D) Quality of life assessment test
Quality 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: At baseline and 3 months
- 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: At baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (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 FallStudies 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
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Álvaro Casas Herrero, MD PhD, Principal investigator, Fundación Miguel Servet - Navarrabiomed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911179
- Sponsor's protocol ID
- CHN-PI20/01546
- Acronym
- Vivifrailcogn
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanchez-Sanchez JL, Udina C, Medina-Rincon A, Esbri-Victor M, Bartolome-Martin I, Moral-Cuesta D, Marin-Epelde I, Ramon-Espinoza F, Latorre MS, Idoate F, Goni-Sarries A, Martinez-Martinez B, Bonet RE, Librero J, Casas-Herrero A. Effect of a multicomponent exercise program and cognitive stimulation (VIVIFRAIL-COGN) on falls in frail community older persons with high risk of falls: study protocol for a randomized multicenter control trial. BMC Geriatr. 2022 Jul 23;22(1):612. doi: 10.1186/s12877-022-03214-0.
PubMed 35870875
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Individualized Combined Intervention (Vivifrail-Cogn) on the Rate of Falling of Frail Older Adults at Risk of Falling Living in the Community: a Multicenter Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04911179
- Acronym / sponsor ID
- Vivifrailcogn / CHN-PI20/01546
- Conditions
- Fall, Frailty, Cognition Disorders in Old Age, Exercise, Cognitive Change
- Keywords
- Fall, Frailty, Cognition Disorders in Old Age, Exercise, Cognitive Change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 2 Jun 2021 (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 clinical trial of 310 older adults over 75 years old recruited from the Falls Units of Geriatric Departments in 4 three University Hospitals in Spain (Pamplona, San Sebastián, Albacete and Barcelona). Participants who met inclusion criteria will be randomized to the usual care group (Otago exercise program) or the Vivifrail-Cog Intervention (a combination of physical exercise Vivifrail program and cognitive training). The main objective of the present randomized clinical trial is to investigate the effect of the combined intervention (exercise and cognitive intervention) in frail older participants living in the community and at risk of falling. The main endpoint will be the rate of falling in the following year. Secondary endpoints include physical performance, muscle strength, cognitive performance, hospitalizations, institutionalization, depression and quality of life.
Detailed description
Usual care: subjects randomized to the usual care group will receive an evidence-based multidisciplinary intervention tailored at reducing the fall risk (polypharmacy, environmental intervention, physical exercise). Importantly, the Otago exercise program (considered the standard physical exercise intervention) will be prescribed in this group.
Intervention group: subjects assigned to this intervention will engage in a multicomponent intervention combining an exercise program, Vivifrail (A practical guide for prescribing a Multicomponent Physical Training Program to prevent weakness and falls in people over 70, more information at www.vivifrail.com) and a cognitive training. Vivifrail exercise program combines resistance, endurance, balance and flexibility exercise tailored to the functional level of the subjects, guaranteeing an individualized approach. Exercises progress in terms of intensity and difficulty as the subject adapts to exercise. The cognitive stimulation program combines exercises to work on different cognitive functions, mainly addressing executive functions (attentional system, processing speed, perceptual organization, working memory and cognitive flexibility, verbal comprehension, abstraction and reasoning, planning, execution and problem solving ).
It lasts 12 weeks, two weekly sessions. It is divided into 4 levels in order to adapt the intervention to participant's individual capacity, and the level can be adjusted throughout the intervention.
Correct execution will be monitored by constant contact with relatives in charge of supervising the exercise program, who will be familiarized with the intervention prior to participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined multicomponent physical exercise and cognitive stimulation (Vivfrail-Cog) | Experimental | Other: Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.The supervised multicomponent exercise training program (resistance, endurance, balance and flexibility) will be comprised of upper and lower body exercises tailored to the individual's functional capacity. Subjects will be encouraged at performing strength and endurance exercise at a moderate intensity. Exercise will progress in terms of intensity and difficulty upon individual adaptation. The cognitive intervention will include the performance of different exercises with pencil and paper in order to train different cognitive areas, especially the executive functions. |
| Usual care | No intervention | –The usual care group will receive normal outpatient care (including the evidence-based Otago exercise program). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥ 75 years or older
- Referral to the Falls Unit
- Ability to ambulate independently with or without technical aids
- Barthel Index ≥ 60
- Pre-frailty (1-2 criteria) or Frailty according to the Frailty Phenotype by Fried et al
Key exclusion criteria (16 listed)
- Unwillingness to either complete the study requirements or to be randomized into the control or the intervention group
- Life expectancy ≤ 3 months
- Terminal illness
- No possibility of follow-up
- Institutionalization 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 |
|---|---|---|
| Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.The areas to be worked on are: Attentional system: selective attention and concentration; alternating attention / dual attention; Processing speed; perceptual organization; working memory and cognitive flexibility; comprehension, abstraction and verbal reasoning, planning, execution, and problem solving. Four programs have been developed stimulation different difficulty levels to adapt to the capabilities of each participant. | Other | Combined multicomponent physical exercise and cognitive stimulation (Vivfrail-Cog) |
Primary outcome
One year falls rate
Time frame: during one year
Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.Subjects will be contacted by phone in a monthly basis after completing the 3-months lasting intervention and inform the research team about the incidence of falls.
One year fall-related hospitalizations
Time frame: during one year
Number of fall-related hospitalizations
One year fall-related fracture
Time frame: during one year
Number of fall-related fracture (radiologically confirmed)
One year fall-related death
Time frame: during one year
Number of fall-related death
26 secondary outcomes
Barthel
Time frame: At baseline, 6-week, 12-week and 24-week and 1-year.
Garvan Fracture Risk
Time frame: At baseline and 12-week
Handgrip Strength in both hands
Time frame: At baseline, 6-week, 12-week
4-metre gait velocity test (GVT)
Time frame: At baseline, 6 week and 3 months.
Short Physical Performance Battery (SPPB)
Time frame: At baseline,1 and 3 months.
Fried's Frailty Phenotype (FP)
Time frame: At baseline and 3 months
SARC-F (Screening of Sarcopenia Among Older Adults)
Time frame: At baseline,1 and 3 months.
Musculoskeletal echography
Time frame: At baseline, 6 weeks and 3 months
MOCA (Montreal Cognitive Assessment) test
Time frame: At baseline, 6 weeks and 3 months
Trail Making Test part A ( TMT-A)
Time frame: At baseline, 6 weeks and 3 months
Falls-related psychological consequences
Time frame: At baseline, 12 week, 24 week and 1 year.
1-Repetition Maximum (RM) Maximal dynamic strength test
Time frame: At baseline, 6 weeks and 3 months
Repetitions at maximal velocity at intensities of 50% of 1RM test
Time frame: At baseline, 6 weeks and 3 months
Geriatric Depression Scale (GDS) Yesavage abbreviated scale
Time frame: At baseline, 6 weeks and 3 months
Mortality
Time frame: At baseline, 6 weeks and 3 months
Admissions to the hospital
Time frame: At baseline, 6 weeks and 3 months
Incidence of institutionalization to nursing homes
Time frame: At baseline, 6 weeks and 3 months
Visit to emergency room
Time frame: At baseline, 6 weeks and 3 months
Number of total Drugs
Time frame: At baseline and 3 months
Presence of 5 or more drugs ( Polypharmacy ) registration
Time frame: At baseline and 3 months
Psychotropic and hypotensive drugs registration
Time frame: At baseline and 3 months
Drug Burden Index
Time frame: At baseline, 3, 6, 9 and 12 months
Dual task gait ( arithmetic) 6 m velocity test
Time frame: At baseline, week 6 and 3 months
Dual task gait (verbal) 6 m velocity test
Time frame: At baseline, 6-week and 3 months
EuroQol-5D (EQ-5D) Quality of life assessment test
Time frame: At baseline and 3 months
- Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )
Time frame: At baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 35870875Sanchez-Sanchez JL, Udina C, Medina-Rincon A, Esbri-Victor M, Bartolome-Martin I, Moral-Cuesta D, Marin-Epelde I, Ramon-Espinoza F, Latorre MS, Idoate F, Goni-Sarries A, Martinez-Martinez B, Bonet RE, Librero J, Casas-Herrero A. Effect of a multicomponent exercise program and cognitive stimulation (VIVIFRAIL-COGN) on falls in frail community older persons with high risk of falls: study protocol for a randomized multicenter control trial. BMC Geriatr. 2022 Jul 23;22(1):612. doi: 10.1186/s12877-022-03214-0.
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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.
Álvaro Casas Herrero, MD PhD principal investigator
Fundación Miguel Servet - 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 Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation. in people with Fall and Frailty, 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 11 inclusion and 16 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 2 Jun 2021. 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 Álvaro 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?
One year falls rate (time frame: during one year). 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?
On the ClinicalTrials.gov record for NCT04911179, 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 2 Jun 2021.