NCT06797440

Brief Summary

Background: Cognitive frailty is a state that combines physical weakness and cognitive impairment. As age increases, the prevalence rate also increases. Older adults with cognitive frailty are prone to falls, limited or degraded physical functions, and are at high risk of becoming disabled. It is an essential predictor of dementia and mortality. There are currently very few randomized controlled trial studies on cognitive frailty abroad. Although there are many related studies on senile frailty in Taiwan, most studies examine cognitive function and physical frailty separately. Since cognitive frailty is reversible, early intervention can delay or prevent the occurrence of cognitive frailty. Therefore, cognitive-motor dual tasks are introduced. For more information, see the effectiveness of dual-tasking in cases of cognitive decline. Purpose: Goal is to not only explore the feasibility of a motor-cognition dual-task program for elderly individuals with cognitive frailty but also to compare its impact on cognitive and physical function with existing training programs. By doing so, the purpose of this study will be to provide practical insights that can inform the development of effective interventions for this vulnerable population. Methods: A randomized clinical trial was used to explore the effectiveness of a dual-task intervention program on cognitive function and physical activity in older adults with cognitive frailty. Eligible subjects were recruited through convenience sampling and randomly assigned to two groups. The experimental group used Nintendo Switch to perform dual tasks of motor cognition, while the control group performed regular activities. Twice a week, 60 minutes each time, for eight weeks of training. Both groups completed basic information (demographics, disease characteristics, and lifestyle), cognitive function measurements, and physical activity function measurements in the pre-test (T0) in the 4th week (T1) and 8th week (T2). Cognitive function measurements and physical activity function measurements were performed again. Using SPSS 29.0 as a statistical tool, independent sample t-test and Chi-square test were used to detect the demographic variables, disease treatment variables, living habits, cognitive functions, and physical effects of the two groups-homogeneity of activities. A generalized estimating equation (GEE) was used as a statistical method to process and analyze repeated measurement data. The effects of the inter-group and time interaction on the two groups' cognitive function and physical activity were studied differently. Expected research results: This study is expected to construct a suitable dual-task program to introduce the role of physical and cognitive function in this group and explore its effectiveness.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

January 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

January 21, 2025

Last Update Submit

March 31, 2025

Conditions

Keywords

Cognitive FrailtyDual taskDigital technologyNintendo SwitchPhysical activityCognition funtion

Outcome Measures

Primary Outcomes (9)

  • Taiwanese version of the Montreal Cognitive Assessment (MoCA-T)

    This scale is used to assess the cognition funtion. The internal consistency Cronbach's coefficient of this tool is 0.83 and the test-retest reliability is 0.92.

    Baseline, pre-intervention (T0)

  • Taiwanese version of the Montreal Cognitive Assessment (MoCA-T)

    This scale is used to assess the cognition funtion. The internal consistency Cronbach's coefficient of this tool is 0.83 and the test-retest reliability is 0.92.

    Four weeks after intervention(T1=4Weeks)

  • Taiwanese version of the Montreal Cognitive Assessment (MoCA-T)

    This scale is used to assess the cognition funtion. The internal consistency Cronbach's coefficient of this tool is 0.83 and the test-retest reliability is 0.92.

    Eight weeks after intervention(T2=8Weeks)

  • Taiwan Odd-Even Number Sequencing Test (TOENS)

    This scale is used to assess the cognition funtion. It's Half-reliability ranged from 0.69 to 0.95, and the test-retest reliability was 0.75.

    Baseline, pre-intervention (T0)

  • Taiwan Odd-Even Number Sequencing Test (TOENS)

    This scale is used to assess the cognition funtion. It's Half-reliability ranged from 0.69 to 0.95, and the test-retest reliability was 0.75.

    Four weeks after intervention(T1=4Weeks)

  • Taiwan Odd-Even Number Sequencing Test (TOENS)

    This scale is used to assess the cognition funtion. It's Half-reliability ranged from 0.69 to 0.95, and the test-retest reliability was 0.75.

    Eight weeks after intervention(T2=8Weeks)

  • Trail Making Test (TMT)

    This scale is used to assess cognition function. The retest reliability of TMT-A is above 0.80 (0.60 \~0.90), and the retest reliability of TMT-B is 0.75

    Baseline, pre-intervention (T0)

  • Trail Making Test (TMT)

    This scale is used to assess cognition function. The retest reliability of TMT-A is above 0.80 (0.60 \~0.90), and the retest reliability of TMT-B is 0.75

    Four weeks after intervention(T1=4Weeks)

  • Trail Making Test (TMT)

    This scale is used to assess cognition function. The retest reliability of TMT-A is above 0.80 (0.60 \~0.90), and the retest reliability of TMT-B is 0.75

    Eight weeks after intervention(T2=8Weeks)

Secondary Outcomes (9)

  • Timed Up and Go (TUG)

    Baseline, pre-intervention (T0)

  • Timed Up and Go (TUG)

    Four weeks after intervention(T1=4Weeks)

  • Timed Up and Go (TUG)

    Eight weeks after intervention

  • Short Physical Performance Battery (SPPB)

    Baseline, pre-intervention (T0)

  • Short Physical Performance Battery (SPPB)

    Four weeks after intervention(T1=4Weeks)

  • +4 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group received a dual-task protocol. The intervention activities of the experimental group were cognitive and physical activity training using Nitendo Switch.

Other: Dual tasks of digital technology

Control group

NO INTERVENTION

The control group received usual care.

Interventions

The intervention activities of this study were cognitive and physical activity training using Nintendo Switch twice a week, 60 minutes each time (5 minutes of warm-up and cool-down exercises, 10 minutes of stretching exercises, and 40 minutes of exercise combined with cognitive training) for a total of 8 weeks. train. Both groups filled in basic data (demographics and disease characteristics) and underwent cognitive function measurements and physical activity function measurements at pretest (T0), 4th week (T1), and 8th week (T2).

Experimental group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 years or older
  • Subjective cognitive decline (measured by SMC with a score of at least 1 point) or mild cognitive impairment (measured by MoCA-T with a score of ≤25 points)
  • Possessing characteristics of physiological frailty (meeting at least one of the above items as measured by FFI)

You may not qualify if:

  • Diagnosed with Alzheimer's disease or other types of dementia
  • Suffering from musculoskeletal diseases and severe mental illness that make it impossible to perform cognitive and motor tasks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 112303, Taiwan

Location

Related Publications (10)

  • Ruan Q, Yu Z, Chen M, Bao Z, Li J, He W. Cognitive frailty, a novel target for the prevention of elderly dependency. Ageing Res Rev. 2015 Mar;20:1-10. doi: 10.1016/j.arr.2014.12.004. Epub 2014 Dec 30.

    PMID: 25555677BACKGROUND
  • Qiu Y, Li G, Wang X, Zheng L, Wang C, Wang C, Chen L. Prevalence of cognitive frailty among community-dwelling older adults: A systematic review and meta-analysis. Int J Nurs Stud. 2022 Jan;125:104112. doi: 10.1016/j.ijnurstu.2021.104112. Epub 2021 Oct 18.

    PMID: 34758429BACKGROUND
  • van Oostrom SH, van der A DL, Rietman ML, Picavet HSJ, Lette M, Verschuren WMM, de Bruin SR, Spijkerman AMW. A four-domain approach of frailty explored in the Doetinchem Cohort Study. BMC Geriatr. 2017 Aug 30;17(1):196. doi: 10.1186/s12877-017-0595-0.

    PMID: 28854882BACKGROUND
  • Mantovani E, Zucchella C, Schena F, Romanelli MG, Venturelli M, Tamburin S. Towards a Redefinition of Cognitive Frailty. J Alzheimers Dis. 2020;76(3):831-843. doi: 10.3233/JAD-200137.

    PMID: 32568197BACKGROUND
  • Lauretani F, Longobucco Y, Ferrari Pellegrini F, De Iorio AM, Fazio C, Federici R, Gallini E, La Porta U, Ravazzoni G, Roberti MF, Salvi M, Zucchini I, Pela G, Maggio M. Comprehensive Model for Physical and Cognitive Frailty: Current Organization and Unmet Needs. Front Psychol. 2020 Nov 26;11:569629. doi: 10.3389/fpsyg.2020.569629. eCollection 2020.

    PMID: 33324282BACKGROUND
  • Kwan RYC, Liu JYW, Fong KNK, Qin J, Leung PK, Sin OSK, Hon PY, Suen LW, Tse MK, Lai CK. Feasibility and Effects of Virtual Reality Motor-Cognitive Training in Community-Dwelling Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Serious Games. 2021 Aug 6;9(3):e28400. doi: 10.2196/28400.

    PMID: 34383662BACKGROUND
  • Kwan RY, Lee D, Lee PH, Tse M, Cheung DS, Thiamwong L, Choi KS. Effects of an mHealth Brisk Walking Intervention on Increasing Physical Activity in Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 31;8(7):e16596. doi: 10.2196/16596.

    PMID: 32735218BACKGROUND
  • Kelaiditi E, Cesari M, Canevelli M, van Kan GA, Ousset PJ, Gillette-Guyonnet S, Ritz P, Duveau F, Soto ME, Provencher V, Nourhashemi F, Salva A, Robert P, Andrieu S, Rolland Y, Touchon J, Fitten JL, Vellas B; IANA/IAGG. Cognitive frailty: rational and definition from an (I.A.N.A./I.A.G.G.) international consensus group. J Nutr Health Aging. 2013 Sep;17(9):726-34. doi: 10.1007/s12603-013-0367-2.

    PMID: 24154642BACKGROUND
  • Junius-Walker U, Onder G, Soleymani D, Wiese B, Albaina O, Bernabei R, Marzetti E; ADVANTAGE JA WP4 group. The essence of frailty: A systematic review and qualitative synthesis on frailty concepts and definitions. Eur J Intern Med. 2018 Oct;56:3-10. doi: 10.1016/j.ejim.2018.04.023. Epub 2018 May 31.

    PMID: 29861330BACKGROUND
  • Jiayuan Z, Xiang-Zi J, Li-Na M, Jin-Wei Y, Xue Y. Effects of Mindfulness-Based Tai Chi Chuan on Physical Performance and Cognitive Function among Cognitive Frailty Older Adults: A Six-Month Follow-Up of a Randomized Controlled Trial. J Prev Alzheimers Dis. 2022;9(1):104-112. doi: 10.14283/jpad.2021.40.

    PMID: 35098980BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Chia-Jung Hsieh, PhD

CONTACT

Chiung Shu Lee, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of digital technology interventions, it is difficult to blind study caregivers and participants.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., RN, Professor

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 28, 2025

Study Start

April 30, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations