Combined Exercise and Cognitive Stimulation for Falls Prevention

NCT ID: NCT04911179

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-04-01

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.

Conditions

Fall; Frailty; Cognition Disorders in Old Age; Exercise; Cognitive Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.

Intervention Type: 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.

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Miguel Servet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Álvaro Casas Herrero, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación Miguel Servet - Navarrabiomed

Locations

Complejo Hospitalario de Navarra. Department of Geriatrics

Pamplona, Navarre, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Álvaro Casas Herrero, MD PhD

Role: CONTACT

alvaro.casas.herrero@navarra.es

+(34)848422287 ext. 21007

Juán Luís Sánchez, PhD

Role: CONTACT

jl.sanchezs@hotmail.com

+(34)662309412

Facility Contacts

Älvaro Casas Herrero, MD PhD

Role: primary

alvaro.casas.herrero@navarra.es

0034848422287 ext. 21007

References

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.

Reference Type: DERIVED

PMID: 35870875 (View on PubMed)

Other Identifiers

CHN-PI20/01546

Identifier Type: -

Identifier Source: org_study_id