- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427225
Dual-Task vs. Multicomponent Exercise in Institutionalized Seniors (DT-Fall)
Effects of Dual-Task Versus Multicomponent Exercise Programs on Fear of Falling and Fall Risk in Institutionalized Older Adults: A Randomized Controlled 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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ageing is a universal biological process. However, the trajectory of physical and cognitive decline varies significantly across individuals based on their lifestyle and environment. Literature consistently demonstrates that older adults residing in long-term care institutions (nursing homes) represent a particularly vulnerable demographic compared to those living in the community. While community-dwelling older adults often maintain a baseline level of physical activity through household chores, social interactions, and recreational tasks, institutionalized older adults frequently face an environment characterized by sedentarism and a lack of autonomy. This environmental physical deprivation in institutional settings leads not only to physical deconditioning (loss of strength, loss of balance, and reduced mobility) but also to a lack of cognitive stimulation. The absence of complex daily challenges means that these individuals rarely engage the neuro-motor pathways required to manage simultaneous tasks. Consequently, institutionalized older adults are at a disproportionately high risk of adverse health outcomes, most notably falls.
Falls are not merely biomechanical events caused by muscle weakness; they are deeply intertwined with psychological factors. Recent systematic reviews highlight fear of falling as a critical health concern that affects a vast majority of institutionalized older adults, regardless of whether they have a history of falling. Fear of falling acts as a psychological barrier that triggers a negative spiral of frailty, specifically, the fear leads to self-imposed activity restriction, which further degrades physical fitness (i.e., strength and balance), thereby paradoxically increasing the actual risk of future falls. Breaking this cycle is imperative. The literature suggests that interventions must address not only the physical capacity to move but also the confidence to move safely. While physical activity is widely recognized as a protective factor, reducing fall risk and promoting independence, the specific type of physical activity that best addresses the psychological aspect of fear of falling remains a subject of investigation.
International guidelines, such as those from the World Health Organization and Cochrane reviews, advocate for multicomponent exercise programs by combining resistance, balance, and aerobic training, as the most effective strategy for fall prevention. These programs, typically prescribed at moderate intensities, have proven effective in improving pure physical parameters like muscle strength and static balance. However, a critical gap exists between clinical improvements and real-world applicability. Standard multicomponent exercise is often performed in controlled environments where the individual focuses exclusively on the motor task (i.e., single tasking). Yet, in daily life, falls rarely occur when an individual is solely focused on walking. Instead, falls predominantly happen during complex, multi-task scenarios, such as walking while talking or carrying objects, navigating obstacles, or processing environmental cues. This discrepancy suggests that traditional multicomponent training may lack ecological validity. It strengthens the muscles but may not sufficiently train the brain to allocate attentional resources efficiently during movement, leaving the older adult vulnerable when distracted.
The Cognitive-Motor Interference theory posits that when older adults with cognitive deficits attempt to perform a motor task and a cognitive task simultaneously, performance in one or both domains deteriorates. This dual-task cost is a strong predictor of falls. Therefore, to effectively reduce fall risk and, crucially, the fear of falling, an intervention must simulate these complex demands. This leads to the hypothesis that dual-task training, the integration of simultaneous cognitive challenges (e.g., verbal fluency, arithmetic calculations, memory recall) into physical exercise, may offer superior benefits to multicomponent training alone. By forcing the central nervous system to manage competing attentional demands, dual-task training aims to improve neuroplasticity and executive function alongside physical conditioning.
The primary aim of this investigation is to determine whether increasing the complexity of the training stimulus (Dual-Task) yields greater benefits than the standard physical stimulus (Multicomponent) in institutionalized older adults. Specifically, this study seeks to understand if adding a cognitive load to a standard exercise protocol is a key ingredient required to significantly reduce fear of falling and improve functional mobility in this specific population. Rather than focusing solely on the volume or intensity of exercise, as emphasized in general guidelines, this research focuses on the specificity of the training type. If dual-task training proves more effective, it suggests that fall prevention strategies in nursing homes should move beyond simple repetitive movements and embrace physical and cognitive training. The findings will support healthcare professionals in tailoring interventions that are not only physically strengthening but also cognitively engaging, ultimately promoting a more robust and confident functional independence among the oldest old.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Filipe Rodrigues, PhD
- Phone Number: +351 244 820 312
- Email: filipe.rodrigues@ipleiria.pt
Study Locations
-
-
Leiria District
-
Alcobaça, Leiria District, Portugal, 2460-009
- Santa Casa da Misericórdia de Alcobaça
-
Contact:
- Maria da Luz Carneiro
- Phone Number: +351 262 508 566
- Email: geral@scmalcobaca.pt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- Ability to understand verbal instructions and communicate.
- Absence of severe cognitive impairment that prevents understanding of the tasks.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Multicomponent Exercise Group
Participants in this group will perform a standard multicomponent exercise program.
|
The 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.
|
|
Experimental: Dual-Task Exercise Group
Participants in this group will perform the multicomponent protocol with added cognitive demands.
|
Participants 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fear of Falling
Time Frame: Baseline (Week 0) and Post-Intervention (Week 13).
|
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).
|
Baseline (Week 0) and Post-Intervention (Week 13).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Functional Mobility and Fall Risk
Time Frame: Baseline (Week 0) and Post-Intervention (Week 13).
|
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.
|
Baseline (Week 0) and Post-Intervention (Week 13).
|
|
Exercise Adherence (Attendance Rate)
Time Frame: Through study completion (up to Week 12).
|
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.
|
Through study completion (up to Week 12).
|
|
Change in Physical Performance
Time Frame: Baseline (Week 0) and Post-Intervention (Week 13).
|
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).
|
Baseline (Week 0) and Post-Intervention (Week 13).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.
- Feng C, Adebero T, DePaul VG, Vafaei A, Norman KE, Auais M. A Systematic Review and Meta-Analysis of Exercise Interventions and Use of Exercise Principles to Reduce Fear of Falling in Community-Dwelling Older Adults. Phys Ther. 2022 Jan 1;102(1):pzab236. doi: 10.1093/ptj/pzab236.
- Schumann M, Feuerbacher JF, Sunkeler M, Freitag N, Ronnestad BR, Doma K, Lundberg TR. Compatibility of Concurrent Aerobic and Strength Training for Skeletal Muscle Size and Function: An Updated Systematic Review and Meta-Analysis. Sports Med. 2022 Mar;52(3):601-612. doi: 10.1007/s40279-021-01587-7. Epub 2021 Nov 10.
- Savvakis I, Adamakidou T, Kleisiaris C. Physical-activity interventions to reduce fear of falling in frail and pre-frail older adults: a systematic review of randomized controlled trials. Eur Geriatr Med. 2024 Apr;15(2):333-344. doi: 10.1007/s41999-024-00944-9. Epub 2024 Feb 27.
- Oliveira ARC, Magueja CMP, Goncalves de Almeida AM. Actions to control the fear of falling in older people: An umbrella review. Arch Gerontol Geriatr. 2026 Feb;141:106087. doi: 10.1016/j.archger.2025.106087. Epub 2025 Nov 20.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CE/IPLEIRIA/88/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fear of Falling
-
National Healthcare Group PolyclinicsActive, not recruitingFear of FallingSingapore
-
Universidad de CaldasUniversidad de ManizalesUnknown
-
Geriatric Education and Research InstituteMonash University; Khoo Teck Puat Hospital; Tan Tock Seng Hospital; Duke-NUS Graduate... and other collaboratorsCompletedFear of Falling | Physical PerformanceSingapore
-
Gerencia de Atención Primaria, MadridUniversidad Complutense de MadridCompletedFear of Falling | Falls | NursingSpain
-
Istanbul University - CerrahpasaCompleted
-
Karlstad UniversityRecruitingHealthy | Fear of Falling | Balance ChangesSweden
-
University Hospital, GenevaCompletedRehabilitation | Fear of Falling | Older AdultsSwitzerland
-
UKK InstitutePirkanmaa Hospital District; Ministry of Education and Culture, FinlandTerminatedFear of Falling | Falls | Physical PerformanceFinland
-
Nagihan AcetCompletedFear of Falling | Fear of MovementTurkey
-
University of Central FloridaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingFall | Fear of Falling | Sedentary Behavior | Physical InactivityUnited States
Clinical Trials on Dual-Task Exercise Program
-
University of ManitobaCompleted
-
Ege UniversityCompleted
-
Izmir Democracy UniversityNot yet recruitingDiabetes Mellitus Type 2Turkey
-
Universitat de LleidaInstitut Catala de SalutNot yet recruitingFrailty | Exercise Training | Frail Elderly | Dual Task Exercises in Elderly People
-
Seoul National University Boramae HospitalNational Rehabilitation Center, Ministry of Health and Welfare, KoreaCompletedCognitive Dysfunction | Mild Cognitive ImpairmentKorea, Republic of
-
Istanbul University - CerrahpasaRecruitingMental RetardationTurkey
-
Loughborough UniversityActive, not recruitingDementia | Mild Cognitive Impairment | Older AdultsUnited Kingdom
-
State University of New York at BuffaloNational Center for Advancing Translational Sciences (NCATS)Completed
-
Bartın UnıversityThe Scientific and Technological Research Council of TurkeyRecruitingDiabetes Mellitus, Type 2Turkey
-
Bezmialem Vakif UniversityCompletedSpecific Learning DisorderTurkey