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Combined Exercise and Cognitive Stimulation for Falls Prevention (Vivifrailcogn)

Primary Purpose

Fall, Frailty, Cognition Disorders in Old Age

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.
Sponsored by
Fundacion Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fall focused on measuring Fall, Frailty, Cognition Disorders in Old Age, Exercise, Cognitive Change

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    • 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

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

  • Complejo Hospitalario de Navarra. Department of GeriatricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Combined multicomponent physical exercise and cognitive stimulation (Vivfrail-Cog)

Usual care

Arm Description

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.

The usual care group will receive normal outpatient care (including the evidence-based Otago exercise program).

Outcomes

Primary Outcome Measures

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.
One year fall-related hospitalizations
Number of fall-related hospitalizations
One year fall-related fracture
Number of fall-related fracture (radiologically confirmed)
One year fall-related death
Number of fall-related death

Secondary Outcome Measures

Barthel
Barthel Index changes from baseline to 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.
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.
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.
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
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.
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.
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).
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
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
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.
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
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
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
Mortality
Mortality will be assessed with a clinical questionnaire during follow up
Admissions to the hospital
New admissions to the hospital will be assessed with a clinical questionnaire during follow up
Incidence of institutionalization to nursing homes
New institutionalizations to nursing homes will be assessed with clinical questionary during follow up
Visit to emergency room
Visits to emergency room will be assessed with a clinical questionnaire during follow up
Number of total Drugs
Number of drugs during follow up will be assessed with a clinical questionnaire
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
Psychotropic and hypotensive drugs registration
Registration of the presence of psychotropic and hypotensive drugs during follow -up will be done with a clinical questionnaire
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.
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
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
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 )
- 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

Full Information

First Posted
May 27, 2021
Last Updated
May 27, 2021
Sponsor
Fundacion Miguel Servet
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1. Study Identification

Unique Protocol Identification Number
NCT04911179
Brief Title
Combined Exercise and Cognitive Stimulation for Falls Prevention
Acronym
Vivifrailcogn
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall, Frailty, Cognition Disorders in Old Age, Exercise, Cognitive Change
Keywords
Fall, Frailty, Cognition Disorders in Old Age, Exercise, Cognitive Change

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined multicomponent physical exercise and cognitive stimulation (Vivfrail-Cog)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The usual care group will receive normal outpatient care (including the evidence-based Otago exercise program).
Intervention Type
Other
Intervention Name(s)
Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.
Intervention Description
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.
Primary Outcome Measure Information:
Title
One year falls rate
Description
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.
Time Frame
during one year
Title
One year fall-related hospitalizations
Description
Number of fall-related hospitalizations
Time Frame
during one year
Title
One year fall-related fracture
Description
Number of fall-related fracture (radiologically confirmed)
Time Frame
during one year
Title
One year fall-related death
Description
Number of fall-related death
Time Frame
during one year
Secondary Outcome Measure Information:
Title
Barthel
Description
Barthel Index changes from baseline to 6-week, 12-week and 24-week and 1-year
Time Frame
At baseline, 6-week, 12-week and 24-week and 1-year.
Title
Garvan Fracture Risk
Description
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.
Time Frame
At baseline and 12-week
Title
Handgrip Strength in both hands
Description
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.
Time Frame
At baseline, 6-week, 12-week
Title
4-metre gait velocity test (GVT)
Description
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.
Time Frame
At baseline, 6 week and 3 months.
Title
Short Physical Performance Battery (SPPB)
Description
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
Time Frame
At baseline,1 and 3 months.
Title
Fried's Frailty Phenotype (FP)
Description
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.
Time Frame
At baseline and 3 months
Title
SARC-F (Screening of Sarcopenia Among Older Adults)
Description
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.
Time Frame
At baseline,1 and 3 months.
Title
Musculoskeletal echography
Description
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).
Time Frame
At baseline, 6 weeks and 3 months
Title
MOCA (Montreal Cognitive Assessment) test
Description
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
Time Frame
At baseline, 6 weeks and 3 months
Title
Trail Making Test part A ( TMT-A)
Description
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
Time Frame
At baseline, 6 weeks and 3 months
Title
Falls-related psychological consequences
Description
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.
Time Frame
At baseline, 12 week, 24 week and 1 year.
Title
1-Repetition Maximum (RM) Maximal dynamic strength test
Description
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
Time Frame
At baseline, 6 weeks and 3 months
Title
Repetitions at maximal velocity at intensities of 50% of 1RM test
Description
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
Time Frame
At baseline, 6 weeks and 3 months
Title
Geriatric Depression Scale (GDS) Yesavage abbreviated scale
Description
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
Time Frame
At baseline, 6 weeks and 3 months
Title
Mortality
Description
Mortality will be assessed with a clinical questionnaire during follow up
Time Frame
At baseline, 6 weeks and 3 months
Title
Admissions to the hospital
Description
New admissions to the hospital will be assessed with a clinical questionnaire during follow up
Time Frame
At baseline, 6 weeks and 3 months
Title
Incidence of institutionalization to nursing homes
Description
New institutionalizations to nursing homes will be assessed with clinical questionary during follow up
Time Frame
At baseline, 6 weeks and 3 months
Title
Visit to emergency room
Description
Visits to emergency room will be assessed with a clinical questionnaire during follow up
Time Frame
At baseline, 6 weeks and 3 months
Title
Number of total Drugs
Description
Number of drugs during follow up will be assessed with a clinical questionnaire
Time Frame
At baseline and 3 months
Title
Presence of 5 or more drugs ( Polypharmacy ) registration
Description
Registration of the presence of 5 or more drugs( Polypharmacy ) during follow -up will be done with a clinical questionnaire
Time Frame
At baseline and 3 months
Title
Psychotropic and hypotensive drugs registration
Description
Registration of the presence of psychotropic and hypotensive drugs during follow -up will be done with a clinical questionnaire
Time Frame
At baseline and 3 months
Title
Drug Burden Index
Description
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.
Time Frame
At baseline, 3, 6, 9 and 12 months
Title
Dual task gait ( arithmetic) 6 m velocity test
Description
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
Time Frame
At baseline, week 6 and 3 months
Title
Dual task gait (verbal) 6 m velocity test
Description
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
Time Frame
At baseline, 6-week and 3 months
Title
EuroQol-5D (EQ-5D) Quality of life assessment test
Description
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 )
Time Frame
At baseline and 3 months
Title
- Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )
Description
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
Time Frame
At baseline and 3 months
Other Pre-specified Outcome Measures:
Title
Mini- Nutritional Assessment (MNA)
Description
The MNA® in the short form (MNA-SF) is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. Is is ranged from 0 to 14. 12-14 points indicates normal nutritional status : 8-11 points: At risk of malnutrition 0-7 points: Malnourished
Time Frame
At baseline
Title
Cumulative Illness Rating Scale for Geriatrics (CIRS-G)
Description
This scoring system measures the chronic medical illness ("morbidity") burden while taking into consideration the severity of chronic diseases in 14 items representing individual body systems. The general rules for severity rating are: 0→No problem affecting that system. Current mild problem or past significant problem. Moderate disability or morbidity and/or requires first line therapy. Severe problem and/or constant and significant disability and/or hard to control chronic problems. Extremely severe problem and/or immediate treatment required and/or organ failure and/or severe functional impairment. The cumulative final score can vary theoretically vary from 0 to 56 (although a very high score is impossible).
Time Frame
At baseline
Title
Gait regularity analysis with an inertial sensor unit
Description
During functional tasks (such as balance, gait and rising form a chair ) and cognitive evaluations (dual tasking), an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Gait regularity analysis will be performed
Time Frame
At baseline, 6-week and3 months
Title
Gait cadence analysis with an inertial sensor unit
Description
During functional tasks (such as balance, gait and rising form a chair ) and cognitive evaluations (dual tasking), an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Gait cadence analysis will be performed
Time Frame
At baseline, 6-week and3 months
Title
Gait variability analysis with an inertial sensor unit
Description
During functional tasks (such as balance, gait and rising form a chair ) and cognitive evaluations (dual tasking), an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Gait variability analysis will be performed
Time Frame
At baseline, 6-week and3 months
Title
Gait symmetry analysis with an inertial sensor unit - Gait symmetry analysis with an inertial sensor unit
Description
During functional tasks (such as balance, gait and rising form a chair ) and cognitive evaluations (dual tasking), an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Gait symmetry analysis will be performed
Time Frame
At baseline, 6-week and3 months
Title
Five Times Sit to Stand peak power analysis test with an inertial sensor unit
Description
During functional Five Times to Stand Test an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Peak power analysis will be performed
Time Frame
At baseline, 6-week and3 months
Title
Five Times Sit to Stand impulse analysis test with an inertial sensor unit
Description
During functional Five Times to Stand Test an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Impulse analysis will be performed
Time Frame
At baseline, 6-week and3 months
Title
Five Times Sit to Stand orientation analysis test with an inertial sensor unit
Description
During functional Five Times to Stand Test an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Orientation analysis will be performed
Time Frame
At baseline, 6-week and3 months
Title
Balance power spectrum analysis test with an inertial sensor unit
Description
During functional balance assessment an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Power spectrum analysis will be performed
Time Frame
At baseline, 6-week and3 months
Title
Balance area analysis test with an inertial sensor unit
Description
During functional balance assessment an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Balance area analysis will be performed
Time Frame
At baseline, 6-week and3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Álvaro Casas Herrero, MD PhD
Phone
+(34)848422287
Ext
21007
Email
alvaro.casas.herrero@navarra.es
First Name & Middle Initial & Last Name or Official Title & Degree
Juán Luís Sánchez, PhD
Phone
+(34)662309412
Email
jl.sanchezs@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Álvaro Casas Herrero, MD PhD
Organizational Affiliation
Fundación Miguel Servet - Navarrabiomed
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario de Navarra. Department of Geriatrics
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Älvaro Casas Herrero, MD PhD
Phone
0034848422287
Ext
21007
Email
alvaro.casas.herrero@navarra.es
First Name & Middle Initial & Last Name & Degree
Álvaro Casas Herrero, MD PhD
First Name & Middle Initial & Last Name & Degree
Juan Luís Sánchez, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35870875
Citation
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. Erratum In: BMC Geriatr. 2023 Jan 19;23(1):31.
Results Reference
derived

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Combined Exercise and Cognitive Stimulation for Falls Prevention

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