Dual-Task vs. Multicomponent Exercise in Institutionalized Seniors

NCT07427225 | Not Yet Recruiting

• 1 other identifier: CE/IPLEIRIA/88/2025
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Fear of Falling

Keywords

Accidental Falls; Exercise Therapy; Postural Balance; Psychomotor Performance; Homes for the Aged

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (Week 0) and Post-Intervention (Week 13).

Secondary Outcomes (3)

• Change in Functional Mobility and Fall Risk

  Baseline (Week 0) and Post-Intervention (Week 13).

• Change in Physical Performance

  Baseline (Week 0) and Post-Intervention (Week 13).

• Exercise Adherence (Attendance Rate)

  Through study completion (up to Week 12).

Study Arms (2)

Multicomponent Exercise Group

ACTIVE COMPARATOR

Participants in this group will perform a standard multicomponent exercise program.

Behavioral: Multicomponent Exercise Program

Dual-Task Exercise Group

EXPERIMENTAL

Participants in this group will perform the multicomponent protocol with added cognitive demands.

Behavioral: Dual-Task Exercise Program

Interventions

Multicomponent Exercise Program BEHAVIORAL

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.

Multicomponent Exercise Group

Dual-Task Exercise Program BEHAVIORAL

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.

Dual-Task Exercise Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead

Study Sites (1)

Santa Casa da Misericórdia de Alcobaça

Alcobaça, Leiria District, 2460-009, Portugal

Location

Related Publications (5)

• 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.

  PMID: 30703272 BACKGROUND

• 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.

  PMID: 34757594 BACKGROUND

• 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.

  PMID: 38411771 BACKGROUND

• 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.

  PMID: 41289647 BACKGROUND

• 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.

  PMID: 34636923 BACKGROUND

Central Study Contacts

Filipe Rodrigues, PhD

CONTACT

+351 244 820 312; filipe.rodrigues@ipleiria.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and the data analysts will be blinded to group allocation to minimize detection and reporting bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to one of two parallel groups: the Multicomponent Exercise Group (Control) or the Dual-Task Exercise Group (Experimental).

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator (filipe.rodrigues@ipleiria.pt). To gain access, data requestors will need to sign a data access agreement.

Locations

PT (1)