About this trial
The aging global population faces a major public health challenge regarding the growing number of older adults in long-term care facilities. Institutionalized older adults exhibit high rates of sedentary behavior, accelerating physiological decline (such as sarcopenia, diminished muscle strength, and impaired balance) and increasing fall risk. Beyond biomechanical risks, the fear of falling acts as a psychological barrier, creating a negative spiral of frailty where a lack of confidence leads to activity restriction. This further reduces functional capacity and paradoxically increases the actual fall risk. Addressing fall risk requires interventions targeting both the physical mechanisms of balance and the psychological mechanisms of self-efficacy.
Current WHO guidelines emphasize multicomponent physical activity (combining balance, strength, and aerobic training) to prevent falls. However, traditional programs may not fully address the cognitive-motor interference of real-world falls, which often occur during complex, divided-attention tasks. Institutionalized older adults often struggle to allocate attentional resources efficiently. This study posits that breaking the spiral of inactivity requires stimulating the complex demands of daily living. The investigators hypothesize that a Dual-Task Exercise Program, integrating cognitive challenges (e.g., executive function tasks, memory recall) into a multicomponent routine, will provide superior benefits compared to a Multicomponent Exercise Program alone. By training cognitive functions to process mental stimuli while maintaining motor control, the goal is to improve physical and cognitive capabilities and enhance participants' confidence.
This randomized controlled trial aims to compare the effects of these two modalities on physical fall risk and psychological fear of falling. Conducted in a nursing home for over 12 weeks, participants will be randomly assigned to either the Control Group (Multicomponent Training: physical strength and balance) or the Experimental Group (Dual-Task Training: physical protocol with simultaneous cognitive stimulation).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 65 years or older.
Resident in the institution (nursing home) for at least 6 months.
Autonomous ambulation capacity (independent walking ability, with or without walking aids like canes or walkers).
Medical clearance/approval to participate in physical exercise.
Disqualifiers
Uncontrolled cardiovascular or metabolic conditions (e.g., severe heart failure, unstable angina, recent myocardial infarction in the last month).
Severe musculoskeletal, visual, or auditory impairments that preclude participation in the exercise program.
Diagnosis of severe dementia or other neurological conditions that prevent following the protocol instructions.
Absence from more than 5 consecutive sessions or attendance of less than 75% of the total sessions.
Trial design
Parallel
Treatments tested in this trial
Multicomponent Exercise Program
BehavioralThe program consists of 45-60 minute sessions, twice a week for 12 weeks. It includes resistance training (using free weights, elastic bands, and body weight), static and dynamic balance training, and aerobic walking exercises. Intensity is moderate, adjusted to individual tolerance using the Borg Scale.
Dual-Task Exercise Program
BehavioralParticipants perform the exact same physical exercises as the control group (same duration, frequency, and intensity), but with simultaneous cognitive tasks designed to induce cognitive-motor interference. Tasks include verbal fluency (naming animals/colors), arithmetic calculations (subtraction), and memory recall while performing motor movements.
Treatment groups
Trial outcomes
Primary outcomes
Change in Fear of Falling
Assessed using the Falls Efficacy Scale International (FES-I). This self-report questionnaire assesses the level of concern about falling during 16 social and physical activities inside and outside the home. Total scores range from 16 (no concern) to 64 (extreme concern).
Secondary outcomes
Change in Functional Mobility and Fall Risk
Assessed using the Timed Up and Go (TUG) test. Measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower times indicate better mobility and reduced fall risk.
Change in Physical Performance
Assessed using the Short Physical Performance Battery (SPPB). A composite score evaluating three domains: balance (side-by-side, semi-tandem, tandem stands), gait speed (4 meters), and chair stand ability (5 repetitions). Total scores range from a minimum of 0 to a maximum of 12. Higher scores indicate a better outcome (better physical function).
Exercise Adherence (Attendance Rate)
Measures the frequency of participation in the assigned exercise program. It will be recorded as the total number of sessions attended by each participant divided by the total number of scheduled sessions (24 sessions), expressed as a percentage. This variable assesses the feasibility and acceptance of the training frequency.
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