Uppsala-Dalarna Dementia and Gait Project

Recruiting

• Conditions: Dementia; Subjective Cognitive Impairment; Dementia Senile; Dementia of Alzheimer Type; Mild Cognitive Impairment; Dementia, Mixed
• Interventions: Diagnostic Test: Timed Up-and-Go (TUG single-task); Diagnostic Test: Timed Up-and-Go dual-task (TUGdt); Diagnostic Test: Clinical functional assessment

• Registration Number: NCT05893524
• Lead Sponsor: Dalarna University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-09
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-29
• Study First Posted: 2023-06-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-12-24
• Study Completion: 2026-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cognitively unimpaired community dwelling people	Timed Up-and-Go dual-task (TUGdt)	Age matched cognitively unimpaired community dwelling people recruited via advertisements.
Cognitively unimpaired community dwelling people recruited for test-retest reliability analysis	Timed Up-and-Go dual-task (TUGdt)	Cognitively unimpaired individuals who agreed to participate in a retesting session.
Cognitively unimpaired community dwelling people recruited for test-retest reliability analysis	Timed Up-and-Go (TUG single-task)	Cognitively unimpaired individuals who agreed to participate in a retesting session.
Persons with cognitive impairment recruited for test-retest reliability analysis	Timed Up-and-Go (TUG single-task)	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.
Persons with cognitive impairment recruited for test-retest reliability analysis	Timed Up-and-Go dual-task (TUGdt)	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.
Persons with cognitive impairment recruited for test-retest reliability analysis	Clinical functional assessment	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.
Patients undergoing memory assessments	Timed Up-and-Go (TUG single-task)	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.
Patients undergoing memory assessments	Clinical functional assessment	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.
Cognitively unimpaired community dwelling people	Clinical functional assessment	Age matched cognitively unimpaired community dwelling people recruited via advertisements.
Cognitively unimpaired community dwelling people recruited for test-retest reliability analysis	Clinical functional assessment	Cognitively unimpaired individuals who agreed to participate in a retesting session.
Patients undergoing memory assessments	Timed Up-and-Go dual-task (TUGdt)	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.
Cognitively unimpaired community dwelling people	Timed Up-and-Go (TUG single-task)	Age matched cognitively unimpaired community dwelling people recruited via advertisements.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Dalarna University; 🇸🇪 Falun, Dalarna County, Sweden

Uppsala University; 🇸🇪 Uppsala, Uppsala County, Sweden