Uppsala-Dalarna Dementia and Gait Project (UDDGait™)

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Mild Cognitive Impairment; Dementia, Mixed; Dementia of Alzheimer Type; Subjective Cognitive Impairment; Dementia Senile
• Intervention / Treatment: Diagnostic test: Timed Up-and-Go (TUG single-task); Diagnostic test: Timed Up-and-Go dual-task (TUGdt); Diagnostic test: Clinical functional assessment

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

• Study Contact: Name: Anna Cristina Åberg, PhD; Phone Number: +4623778082; Email: aab@du.se
• Study Contact Backup: Name: Vilmantas Giedraitis, PhD; Phone Number: +46734697455; Email: vgi@du.se

Study Locations

• Sweden
  • Dalarna County
    • Falun, Dalarna County, Sweden, 79188
      • Completed
      • Dalarna University
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 751 22
      • Recruiting
      • Uppsala University
      • Contact: Anna Cristina Åberg, PhD; Phone Number: +4623778082; Email: Anna.Cristina.Aberg@pubcare.uu.se
      • Contact: Vilmantas Giedraitis, PhD; Phone Number: +46734697455; Email: Vilmantas.Giedraitis@pubcare.uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dalarna University
• Collaborators: Uppsala University; The Swedish Research Council
• Investigators: Principal Investigator: Anna Cristina Åberg, PhD, Dalarna University

Publications and helpful links

General Publications

• Ahman HB, Giedraitis V, Cedervall Y, Lennhed B, Berglund L, McKee K, Kilander L, Rosendahl E, Ingelsson M, Aberg AC. Dual-Task Performance and Neurodegeneration: Correlations Between Timed Up-and-Go Dual-Task Test Outcomes and Alzheimer's Disease Cerebrospinal Fluid Biomarkers. J Alzheimers Dis. 2019;71(s1):S75-S83. doi: 10.3233/JAD-181265.
• Cedervall Y, Stenberg AM, Ahman HB, Giedraitis V, Tinmark F, Berglund L, Halvorsen K, Ingelsson M, Rosendahl E, Aberg AC. Timed Up-and-Go Dual-Task Testing in the Assessment of Cognitive Function: A Mixed Methods Observational Study for Development of the UDDGait Protocol. Int J Environ Res Public Health. 2020 Mar 5;17(5):1715. doi: 10.3390/ijerph17051715.
• Ahman HB, Cedervall Y, Kilander L, Giedraitis V, Berglund L, McKee KJ, Rosendahl E, Ingelsson M, Aberg AC. Dual-task tests discriminate between dementia, mild cognitive impairment, subjective cognitive impairment, and healthy controls - a cross-sectional cohort study. BMC Geriatr. 2020 Jul 29;20(1):258. doi: 10.1186/s12877-020-01645-1.
• B Ahman H, Berglund L, Cedervall Y, Kilander L, Giedraitis V, J McKee K, Ingelsson M, Rosendahl E, Aberg AC. Dual-Task Tests Predict Conversion to Dementia-A Prospective Memory-Clinic-Based Cohort Study. Int J Environ Res Public Health. 2020 Nov 3;17(21):8129. doi: 10.3390/ijerph17218129.

Helpful Links

• Project website
• Project summary in Dalarna University research project database

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2015
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2026

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Mild Cognitive Impairment; Dementia; Cognitive tests; Timed Up-and-Go, TUG; TUG dual-task; Subjective Cognitive Impairment; Step parameters; Video recorded tests
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: HDA2021-00022; PUBCARE2016_122 (Other Identifier: Uppsala University, Sweden)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No