Combined Exercise and Cognitive Stimulation for Falls Prevention

NCT04911179 | Unknown

• 1 other identifier: CHN-PI20/01546
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  during one year

• One year fall-related hospitalizations

  Number of fall-related hospitalizations

  during one year

• One year fall-related fracture

  Number of fall-related fracture (radiologically confirmed)

  during one year

• One year fall-related death

  Number of fall-related death

  during one year

Secondary Outcomes (26)

• Barthel

  At baseline, 6-week, 12-week and 24-week and 1-year.

• Garvan Fracture Risk

  At baseline and 12-week

• Handgrip Strength in both hands

  At baseline, 6-week, 12-week

• 4-metre gait velocity test (GVT)

  At baseline, 6 week and 3 months.

• Short Physical Performance Battery (SPPB)

  At baseline,1 and 3 months.

Other Outcomes (11)

• Mini- Nutritional Assessment (MNA)

  At baseline

• Cumulative Illness Rating Scale for Geriatrics (CIRS-G)

  At baseline

• Gait regularity analysis with an inertial sensor unit

  At baseline, 6-week and3 months

Study Arms (2)

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.

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).

Interventions

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.

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Complejo Hospitalario de Navarra. Department of Geriatrics

Pamplona, Navarre, 31008, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 35870875 DERIVED

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Álvaro Casas Herrero, MD PhD

  Fundación Miguel Servet - Navarrabiomed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Álvaro Casas Herrero, MD PhD

CONTACT

+(34)848422287; alvaro.casas.herrero@navarra.es

Juán Luís Sánchez, PhD

CONTACT

+(34)662309412; jl.sanchezs@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

ES (1)