Uppsala-Dalarna Dementia and Gait Project

Study Overview
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Brief Summary
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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.

Official Title
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Uppsala-Dalarna Dementia and Gait Project

Conditions
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Dementia, Dementia, Mixed, Dementia Senile, Dementia of Alzheimer Type, Mild Cognitive Impairment, Subjective Cognitive Impairment

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 37 Years
Maximum Age: 94 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing memory assessments<br>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)<br>* 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.<br>Diagnostic Test: Timed Up-and-Go dual-task (TUGdt)<br>* 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.<br>Diagnostic Test: Clinical functional assessment<br>* 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.<br>|
| Cognitively unimpaired community dwelling people<br>Age matched cognitively unimpaired community dwelling people recruited via advertisements. | Diagnostic Test: Timed Up-and-Go (TUG single-task)<br>* 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.<br>Diagnostic Test: Timed Up-and-Go dual-task (TUGdt)<br>* 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.<br>Diagnostic Test: Clinical functional assessment<br>* 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.<br>|
| Cognitively unimpaired community dwelling people recruited for test-retest reliability analysis<br>Cognitively unimpaired individuals who agreed to participate in a retesting session. | Diagnostic Test: Timed Up-and-Go (TUG single-task)<br>* 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.<br>Diagnostic Test: Timed Up-and-Go dual-task (TUGdt)<br>* 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.<br>Diagnostic Test: Clinical functional assessment<br>* 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.<br>|
| Persons with cognitive impairment recruited for test-retest reliability analysis<br>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)<br>* 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.<br>Diagnostic Test: Timed Up-and-Go dual-task (TUGdt)<br>* 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.<br>Diagnostic Test: Clinical functional assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Upp to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Step parameters, Video recorded tests, Timed Up-and-Go, TUG, TUG dual-task, Cognitive tests, Dementia, Mild Cognitive Impairment, Subjective Cognitive Impairment