Combined Exercise and Cognitive Stimulation for Falls Prevention

Fundacion Miguel Servet310 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: during one year

One year fall-related hospitalizations

Number of fall-related hospitalizations

Time frame: during one year

One year fall-related fracture

Number of fall-related fracture (radiologically confirmed)

Time frame: during one year

One year fall-related death

Number of fall-related death

Time frame: during one year

Secondary Outcomes

Barthel

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.

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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).