NCT05893524

Brief Summary

UDDGait™ is a multidisciplinary research project with the overreaching goal of providing an aid for early identification of cognitive impairment and risk of dementia development, thereby providing a basis for adequate symptom relieving and health promoting interventions. A new concept is investigated for this purpose: a "dual-task-test", which implies the combination of a well-established mobility test (Timed Up-and-Go, TUG) with a simultaneous verbal task (i.e. TUG dual-task, TUGdt). This type of test has been judged as a potential aid for early identification of dementia disease. More research is needed to further examine the test's validity, reliability and predictive capacity. The overall aim is to investigate if TUGdt is useful as an aid for prediction of dementia disease. To ensure the results, the aim is also to evaluate the test's measurement properties and to generate normative reference values of healthy control persons.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
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 Progress95%
Apr 2015Dec 2026

Study Start

First participant enrolled

April 9, 2015

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2026

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

11.7 years

First QC Date

May 12, 2023

Last Update Submit

February 11, 2025

Conditions

Keywords

Timed Up-and-Go, TUGTUG dual-taskCognitive testsDementiaMild Cognitive ImpairmentSubjective Cognitive ImpairmentAlzheimer's diseaseStep parametersVideo recorded tests

Outcome Measures

Primary Outcomes (1)

  • Conversion to dementia

    Diagnostic information for follow-ups and eventual dates of death, all participants' medical records will be reviewed by an experienced geriatrician. Participants will be classified as having "converted" after receiving a dementia diagnosis, and as "not converted" when a diagnosis of Subjective or Mild cognitive impairment had been confirmed after baseline, or when a reversion to normal cognition had been stated. TUG and TUGdt parameters and composite indices will be examined for association with dementia incidence through Cox regression models with and without adjustment for possible confounding variables such as age, gender, and education. Possible occurrence of gender differences in associations between TUG parameters and dementia incidence will be examined. Optimal cut-off values for predictive TUG parameters (including composite indices) will be estimated. Also, sensitivity, specificity, c-statistics, and Youden's J index will be estimated.

    Upp to 10 years

Secondary Outcomes (1)

  • Level of cognitive functioning

    Upp to 10 years

Study Arms (4)

Patients undergoing memory assessments

Patients undergoing memory assessments at two specialist memory clinics (Uppsala University Hospital in Uppsala and Falu Hospital in Falun). This group includes patients with dementia, mild cognitive impairment and subjective cognitive impairment.

Diagnostic Test: Timed Up-and-Go (TUG single-task)Diagnostic Test: Timed Up-and-Go dual-task (TUGdt)Diagnostic Test: Clinical functional assessment

Cognitively unimpaired community dwelling people

Age matched cognitively unimpaired community dwelling people recruited via advertisements.

Diagnostic Test: Timed Up-and-Go (TUG single-task)Diagnostic Test: Timed Up-and-Go dual-task (TUGdt)Diagnostic Test: Clinical functional assessment

Cognitively unimpaired community dwelling people recruited for test-retest reliability analysis

Cognitively unimpaired individuals who agreed to participate in a retesting session.

Diagnostic Test: Timed Up-and-Go (TUG single-task)Diagnostic Test: Timed Up-and-Go dual-task (TUGdt)Diagnostic Test: Clinical functional assessment

Persons with cognitive impairment recruited for test-retest reliability analysis

Patients undergoing memory assessment at Uppsala University Hospital who agreed to participate in a retesting session and community dwelling older persons with self-reported subjective or mild cognitive impairment. This group includes patients with dementia, mild cognitive impairment and subjective cognitive impairment.

Diagnostic Test: Timed Up-and-Go (TUG single-task)Diagnostic Test: Timed Up-and-Go dual-task (TUGdt)Diagnostic Test: Clinical functional assessment

Interventions

The TUG test is a well-established clinical test of one mobility sequence: rising from an armchair, walking straight ahead, passing a line marked on the floor, turning around, walking back, and sitting down again.

Cognitively unimpaired community dwelling peopleCognitively unimpaired community dwelling people recruited for test-retest reliability analysisPatients undergoing memory assessmentsPersons with cognitive impairment recruited for test-retest reliability analysis

Two dual-task tests including TUG (TUGdt) were carried out: TUGdt naming animals and TUGdt months backwards. The outcomes registered were: time scores for TUG single-task and both TUGdt tests, TUGdt costs (relative time difference between TUG single-task and TUGdt), number of different animals named, number of months recited in correct order, number of animals per 10 s, and number of months per 10 s.

Cognitively unimpaired community dwelling peopleCognitively unimpaired community dwelling people recruited for test-retest reliability analysisPatients undergoing memory assessmentsPersons with cognitive impairment recruited for test-retest reliability analysis

The diagnostic procedure was part of the clinical routine for patients undergoing memory assessment and involved a geriatrician's careful evaluation of the patient's history and cognitive testing including Mini-Mental State Examination (MMSE), Clock Drawing Test, Verbal Fluency Test, and Trail Making Test A and B. In addition, all participants carried out short versions of the Geriatric Depression Scale and the General Motor Function Assessment Scale, as well as static balance according to the Bohannon Method, and hand grip strength using a dynamometer.

Cognitively unimpaired community dwelling peopleCognitively unimpaired community dwelling people recruited for test-retest reliability analysisPatients undergoing memory assessmentsPersons with cognitive impairment recruited for test-retest reliability analysis

Eligibility Criteria

Age37 Years - 94 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients have been consecutively included when undergoing memory assessment at two specialist clinics in Sweden during the study recruitment period (April 2015 to February 2017 at Uppsala University Hospital and June 2015 to June 2016 at Falu Hospital). Age matched cognitively unimpaired community dwelling individuals without cognitive impairment were recruited through advertisements and flyers (May 2017 to March 2019 in Uppsala).

You may qualify if:

  • Patients undergoing memory assessment at at Uppsala University Hospital, Sweden
  • Patients undergoing memory assessment at at Falu Hospital, Sweden
  • Cognitively unimpaired individuals with a Mini Mental State Examination (MMSE) score of \> 26

You may not qualify if:

  • Inability to walk three meters back and forth
  • Inability to rise from a sitting position
  • Indoor use of a walking aid
  • Current or recent hospitalization (within the last 2 weeks)
  • Need of an interpreter to communicate in Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dalarna University

Falun, Dalarna County, 79188, Sweden

COMPLETED

Uppsala University

Uppsala, Uppsala County, 751 22, Sweden

RECRUITING

Related Publications (8)

  • Ahman HB, Giedraitis V, Cedervall Y, Lennhed B, Berglund L, McKee K, Kilander L, Rosendahl E, Ingelsson M, Aberg AC. Dual-Task Performance and Neurodegeneration: Correlations Between Timed Up-and-Go Dual-Task Test Outcomes and Alzheimer's Disease Cerebrospinal Fluid Biomarkers. J Alzheimers Dis. 2019;71(s1):S75-S83. doi: 10.3233/JAD-181265.

    PMID: 31104024BACKGROUND
  • Cedervall Y, Stenberg AM, Ahman HB, Giedraitis V, Tinmark F, Berglund L, Halvorsen K, Ingelsson M, Rosendahl E, Aberg AC. Timed Up-and-Go Dual-Task Testing in the Assessment of Cognitive Function: A Mixed Methods Observational Study for Development of the UDDGait Protocol. Int J Environ Res Public Health. 2020 Mar 5;17(5):1715. doi: 10.3390/ijerph17051715.

    PMID: 32150995BACKGROUND
  • Ahman HB, Cedervall Y, Kilander L, Giedraitis V, Berglund L, McKee KJ, Rosendahl E, Ingelsson M, Aberg AC. Dual-task tests discriminate between dementia, mild cognitive impairment, subjective cognitive impairment, and healthy controls - a cross-sectional cohort study. BMC Geriatr. 2020 Jul 29;20(1):258. doi: 10.1186/s12877-020-01645-1.

  • B Ahman H, Berglund L, Cedervall Y, Kilander L, Giedraitis V, J McKee K, Ingelsson M, Rosendahl E, Aberg AC. Dual-Task Tests Predict Conversion to Dementia-A Prospective Memory-Clinic-Based Cohort Study. Int J Environ Res Public Health. 2020 Nov 3;17(21):8129. doi: 10.3390/ijerph17218129.

  • Lofgren N, Giedraitis V, Halvorsen K, Rosendahl E, Aberg AC. The Timed Up and Go dual-task test's cognitive and motor outcomes show promising test-retest reliability in older adults with perceived memory impairment. Front Aging. 2026 Jan 8;6:1715756. doi: 10.3389/fragi.2025.1715756. eCollection 2025.

  • Lofgren N, Berglund L, Giedraitis V, Rosendahl E, Aberg AC. Can Turn Duration and Step Parameters During the Timed Up and Go Test With and Without a Dual-Task Discriminate Between Individuals With Different Cognitive Abilities? An Explorative Study. Assessment. 2026 Jan 22:10731911251410337. doi: 10.1177/10731911251410337. Online ahead of print.

  • Lofgren N, Berglund L, Giedraitis V, Halvorsen K, Rosendahl E, McKee KJ, Aberg AC. Extracted step parameters during the timed up and go test discriminate between groups with different levels of cognitive ability-a cross-sectional study. BMC Geriatr. 2025 Mar 17;25(1):182. doi: 10.1186/s12877-025-05828-6.

  • Aberg AC, Petersson JR, Giedraitis V, McKee KJ, Rosendahl E, Halvorsen K, Berglund L. Prediction of conversion to dementia disorders based on timed up and go dual-task test verbal and motor outcomes: a five-year prospective memory-clinic-based study. BMC Geriatr. 2023 Sep 2;23(1):535. doi: 10.1186/s12877-023-04262-w.

Related Links

MeSH Terms

Conditions

DementiaMixed DementiasAlzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesCognition Disorders

Study Officials

  • Anna Cristina Åberg, PhD

    Dalarna University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Cristina Åberg, PhD

CONTACT

Vilmantas Giedraitis, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2023

First Posted

June 8, 2023

Study Start

April 9, 2015

Primary Completion (Estimated)

December 24, 2026

Study Completion (Estimated)

December 24, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations