UDDGait™: Uppsala-Dalarna Dementia and Gait Project

Sponsor

Dalarna University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05893524

Collaborator

Uppsala University (Other), The Swedish Research Council (Other)

550

Enrollment

Locations

140.5

Anticipated Duration (Months)

275

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Dementia, Mixed Dementia Senile Dementia of Alzheimer Type Mild Cognitive Impairment 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

Study Design

Study Type:

Observational

Anticipated Enrollment :

550 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Uppsala-Dalarna Dementia and Gait Project

Actual Study Start Date :

Apr 9, 2015

Anticipated Primary Completion Date :

Dec 24, 2026

Anticipated Study Completion Date :

Dec 24, 2026

Arms and Interventions

Arm	Intervention/Treatment
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) 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. Diagnostic Test: Timed Up-and-Go dual-task (TUGdt) 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. Diagnostic Test: Clinical functional assessment 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 people Age matched cognitively unimpaired community dwelling people recruited via advertisements.	Diagnostic Test: Timed Up-and-Go (TUG single-task) 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. Diagnostic Test: Timed Up-and-Go dual-task (TUGdt) 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. Diagnostic Test: Clinical functional assessment 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 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) 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. Diagnostic Test: Timed Up-and-Go dual-task (TUGdt) 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. Diagnostic Test: Clinical functional assessment 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.
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) 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. Diagnostic Test: Timed Up-and-Go dual-task (TUGdt) 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. Diagnostic Test: Clinical functional assessment 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.

Outcome Measures

Primary Outcome Measures

Conversion to dementia [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 Outcome Measures

Level of cognitive functioning [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

37 Years to 94 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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