Uppsala-Dalarna Dementia and Gait Project

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age37-94
SponsorDalarna University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

550 Participants
are divided into 4 treatment groups
Group A: Patients undergoing memory assessments3 interventions
Group B: Cognitively unimpaired community dwelling people3 interventions
Group C: Cognitively unimpaired community dwelling people recruited for test-retest reliability analysis3 interventions
Group D: Persons with cognitive impairment recruited for test-retest reliability analysis3 interventions

Trial outcomes

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.

Time frame
Upp to 10 years

Secondary outcomes

1

Level of cognitive functioning

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.

Time frame
Upp to 10 years

Other outcomes

Sponsors and contacts

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Dalarna University

Lead sponsor

Uppsala University

Collaborator

The Swedish Research Council

Collaborator