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NCT Number: NCT05893524

Uppsala-Dalarna Dementia and Gait Project

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.

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Key information

Age range

37 year–94 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dalarna University, Falun, Dalarna County, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Timed Up-and-Go (TUG single-task)

Diagnostic Test

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.

Timed Up-and-Go dual-task (TUGdt)

Diagnostic Test

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.

Clinical functional assessment

Diagnostic Test

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.

Primary outcomes

  1. Conversion to dementia

    Time frame: Upp to 10 years

    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.

Secondary outcomes

  1. Level of cognitive functioning

    Time frame: Upp to 10 years

    Similarly to TUG and TUGdt parameters, association between different cognitive test results and dementia incidence through Cox regression models with and without adjustment for possible confounding variables such as age, gender, and education will be examined.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Cristina Åberg, PhD

CONTACT

[email protected]

+4623778082

Vilmantas Giedraitis, PhD

CONTACT

[email protected]

+46734697455

Sponsors and collaborators

Lead sponsor

Dalarna University

Other

Collaborators

  • The Swedish Research Council
  • Uppsala University

Registry information

Acronym: UDDGait™

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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