Clinical trial NCT04911179: Combined Exercise and Cognitive Stimulation for Falls Prevention
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
Overall status: UNKNOWN
Phase: NA
Conditions: Fall
Frailty
Cognition Disorders in Old Age
Exercise
Cognitive Change
Keywords: Fall
Frailty
Cognition Disorders in Old Age
Exercise
Cognitive Change
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 310
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: One year falls rate
timeFrame: during one year
measure: One year fall-related hospitalizations
timeFrame: during one year
measure: One year fall-related fracture
timeFrame: during one year
measure: One year fall-related death
timeFrame: during one year
Secondary outcomes:
measure: Barthel
timeFrame: At baseline, 6-week, 12-week and 24-week and 1-year.
measure: Garvan Fracture Risk
timeFrame: At baseline and 12-week
measure: Handgrip Strength in both hands
timeFrame: At baseline, 6-week, 12-week
measure: 4-metre gait velocity test (GVT)
timeFrame: At baseline, 6 week and 3 months.
measure: Short Physical Performance Battery (SPPB)
timeFrame: At baseline,1 and 3 months.
measure: Fried's Frailty Phenotype (FP)
timeFrame: At baseline and 3 months
measure: SARC-F (Screening of Sarcopenia Among Older Adults)
timeFrame: At baseline,1 and 3 months.
measure: Musculoskeletal echography
timeFrame: At baseline, 6 weeks and 3 months
measure: MOCA (Montreal Cognitive Assessment) test
timeFrame: At baseline, 6 weeks and 3 months
measure: Trail Making Test part A ( TMT-A)
timeFrame: At baseline, 6 weeks and 3 months
measure: Falls-related psychological consequences
timeFrame: At baseline, 12 week, 24 week and 1 year.
measure: 1-Repetition Maximum (RM) Maximal dynamic strength test
timeFrame: At baseline, 6 weeks and 3 months
measure: Repetitions at maximal velocity at intensities of 50% of 1RM test
timeFrame: At baseline, 6 weeks and 3 months
measure: Geriatric Depression Scale (GDS) Yesavage abbreviated scale
timeFrame: At baseline, 6 weeks and 3 months
measure: Mortality
timeFrame: At baseline, 6 weeks and 3 months
measure: Admissions to the hospital
timeFrame: At baseline, 6 weeks and 3 months
measure: Incidence of institutionalization to nursing homes
timeFrame: At baseline, 6 weeks and 3 months
measure: Visit to emergency room
timeFrame: At baseline, 6 weeks and 3 months
measure: Number of total Drugs
timeFrame: At baseline and 3 months
measure: Presence of 5 or more drugs ( Polypharmacy ) registration
timeFrame: At baseline and 3 months
measure: Psychotropic and hypotensive drugs registration
timeFrame: At baseline and 3 months
measure: Drug Burden Index
timeFrame: At baseline, 3, 6, 9 and 12 months
measure: Dual task gait ( arithmetic) 6 m velocity test
timeFrame: At baseline, week 6 and 3 months
measure: Dual task gait (verbal) 6 m velocity test
timeFrame: At baseline, 6-week and 3 months
measure: EuroQol-5D (EQ-5D) Quality of life assessment test
timeFrame: At baseline and 3 months
measure: - Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )
timeFrame: At baseline and 3 months
Other outcomes:
measure: Mini- Nutritional Assessment (MNA)
timeFrame: At baseline
measure: Cumulative Illness Rating Scale for Geriatrics (CIRS-G)
timeFrame: At baseline
measure: Gait regularity analysis with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
measure: Gait cadence analysis with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
measure: Gait variability analysis with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
measure: Gait symmetry analysis with an inertial sensor unit - Gait symmetry analysis with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
measure: Five Times Sit to Stand peak power analysis test with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
measure: Five Times Sit to Stand impulse analysis test with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
measure: Five Times Sit to Stand orientation analysis test with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
measure: Balance power spectrum analysis test with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
measure: Balance area analysis test with an inertial sensor unit
timeFrame: At baseline, 6-week and3 months
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra. Department of Geriatrics
state: Navarra
Study officials:
affiliation: Fundación Miguel Servet - Navarrabiomed
name: Álvaro Casas Herrero, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.