Evaluation of the Measurement Properties of a 5 Time Repeated Instrumented Timed Up and Go (5iTUG) (5iTUG)

September 24, 2019 updated by: Corinna Nerz, Robert Bosch Gesellschaft für Medizinische Forschung mbH

Protocol for the Method Study: Evaluation of the Measurement Properties of an Instrumented and Repeated Timed Up and Go (5iTUG)

In order to tailor interventions, objective assessments of physical function is needed. A limitation of several of today's clinical assessments is that they require too much time and/or space. The Timed Up and Go (TUG) is a commonly used clinical test of physical function in older populations. The TUG is particularly useful due to its short administration time and the little space that is required. The TUG is however of limited value when used in higher-functioning older adults due to ceiling effects. Instrumented versions of TUG (iTUG) computes several outcome measures in addition to the traditional outcome measure which is the total duration. The aim of this study is to evaluate the construct- and discriminative validity of outcomes derived from sensor signals recorded with a smartphone during a five times repeated iTUG (5iTUG).

Study Overview

Detailed Description

At "Robert-Bosch-Krankenhaus" (RBK) in Stuttgart the investigators aim to recruit a sample consisting of 60 geriatric participants. The sample will recruited from a mix of health care settings in order to allow for cohort specific analysis.

The first 20 participants will be recruited from the inpatient rehabilitation ward at RBK. The treating medical doctor and Prof Dr Clemens Becker will inform potentially eligible participants about the possibility of being involved in this study. Should participants confirm their interest a research assistant will complete a detailed information session and obtain written informed consent prior enrolment.

Further 20 participants will be recruited through the outpatient rehabilitation clinic at RBK. The treating doctor will again inform the potential participant about the study and invite them to 6 participate. A research assistant will complete a detailed information session and written informed consent will be obtained prior enrolment.

Lastly 20 community dwelling older adults will be invited to participate. Recruitment will occur through advertisement at a locally run seniors fitness group, conducted every Thursday at RBK. Older adults who are interested in being involved will be invited to receive additional information about the study and the involved procedures before providing written informed consent and being enrolled.

All participation is entirely voluntary. Participants are free to withdraw at any time without stating a reason. Withdrawal or non-participation will not impact the care and services they are receiving or will receive from RBK now or in the future.

The following inclusion criteria will be used: community-dwelling, aged between 60 and 80 years and are able to walk 30m independently. Participants will be excluded if they report any severe cardiovascular, pulmonary, neurological, or mental diseases.

In Trondheim researchers will recruit and include 20 healthy seniors, men and women, from senior exercise groups in local fitness centres and the municipality of Trondheim. They will approach leaders or instructors of the exercise groups and ask them to contact the participants in their exercise groups to ask whether they want to take part in this study. Those who are willing will be contacted by a research coordinator. Written informed consent will be obtained prior enrolment.

Participants will be randomized to start with either the five times repeated instrumented Time up an Go Test (5iTUG) or clinical tests. The clinical tests include seven tests: the Community Balance and Mobility Scale (CBMS) (only the group of healthy participants), 8-level Balance Scale, 30s Chair stand (CS), Five times sit-to-stand (STS), Short Physical Performance Battery (SPPB), fast and habitual gait speed over 7 meters. Participants will complete the clinical tests according to the current standard clinical procedures. For the 5iTUG, participants will be instructed to do the Time up and Go Test (TUG) five times with 30 seconds rest between each repetition. The assessor will tell the participant when they should start walking. Participants will wear a smartphone attached with a belt to their lower back during the entire test sequence, both during the clinical tests and the 5iTUG. The assessor will demonstrate each test before the participants start. Participants can take breaks between tests or trials if needed. The assessor is experienced with testing of physical function in older adults, and will stand close to participants during all tasks especially where balance is challenged. At the end of the test-session, the assessor will administer one questionnaire about activities of daily living (ADL) function (the Late Life Function and Disability (LLFDI) questionnaire) and cognitive impairment based on screening via the Montreal Cognitive Assessment (MoCA).

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany, 70376
        • Robert-Bosch-Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The first 20 participants will be recruited from the inpatient rehabilitation ward at Robert-Bosch-Hospital.

Further 20 participants will be recruited through the outpatient rehabilitation clinic at Robert-Bosch-Hospital.

Lastly 20 community dwelling older adults will be invited to participate.

Description

Inclusion Criteria:

  • community-dwelling
  • aged between 60 and 80 years
  • are able to walk 30m independently

Exclusion Criteria:

  • any severe cardiovascular, pulmonary, neurological, or mental diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
inpatient rehabilitation ward

The first 20 participants will be recruited from the inpatient rehabilitation ward at Robert-Bosch-Hospital (RBK). The treating medical doctor will inform potentially eligible participants about the possibility of being involved in this study. Should participants confirm their interest a research assistant will complete a detailed information session and obtain written informed consent prior enrolment.

Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).

outpatient rehabilitation clinic

Further 20 participants will be recruited through the outpatient rehabilitation clinic at Robert-Bosch-Hospital (RBK). The treating doctor will again inform the potential participant about the study and invite them to participate. A research assistant will complete a detailed information session and written informed consent will be obtained prior enrolment.

Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).

community dwelling older adults

Lastly 20 community dwelling older adults will be invited to participate. Recruitment will occur through advertisement at a locally run seniors fitness group, conducted every Thursday at RBK. Older adults who are interested in being involved will be invited to receive additional information about the study and the involved procedures before providing written informed consent and being enrolled.

Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
five time repeated instrumented time up and Go Test (5iTUG)
Time Frame: Baseline
Discriminative ability of the 5iTUG compared to other clinical measurements (include acceleration, velocity, duration of movements, number of steps, and step variability, from the different sub-phases of the TUG test, such as sit-to-walk, walk, first/last turn, and walk-to-sit). By performing five repetitions of an instrumented TUG (5iTUG), it is possible to get features that are more sensitive from the instrument, in addition to in total five repetitions of sit-to-stand, turning, and turn-to-sit movements, along with a total of 30 meters of walking. The 5iTUG quantifies the movement characteristics from tasks that resembles those carried out in other independent clinical measurements and test batteries, such as the Five times sit-to-stand, gait assessments, and 30s chair stand. Variability repetitions within the trials will be analysed using a repeated measures analysis.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
five time Sit to Stand (5xSTS)
Time Frame: Baseline
needed time for 5 time repeated sit to stand
Baseline
30 seconds Chair Stand (30s CS)
Time Frame: Baseline
30 seconds chair stand number of repetitions
Baseline
Gait speed
Time Frame: Baseline
Gait speed measurement over 7 meters (habitual and fast gait speed), stopped with stopwatch
Baseline
Community Balance and Mobility Scale (CBMS)
Time Frame: Baseline
Community Balance and Mobility Scale, Score range from 0-96 points (with 96 is the best performance), duration: 35 minutes
Baseline
8-level balance score
Time Frame: Baseline
8-level balance score, each balance position held for 15 seconds, test stopped when position can not be completed, scored out of 8, higher points indicate better performance
Baseline
Short Physical Performance Battery (SPPB)
Time Frame: Baseline
Short Physical Performance Battery total and sub-scores, 3 balance tests each balance position held for 10 seconds, test stopped when position can not be completed, habitual gait speed over 4m, 5 time sit to stand, higher points indicate better performance, score range 0-12, duration: 8 minutes
Baseline
Late Life Function and Disability questionnaire for Function (LLFDI)
Time Frame: Baseline
Late Life Function and Disability (LLFDI) questionnaire, subjective measurement of functional ability and disability, scale range 0-100 points, higher points indicate better performance
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2018

Primary Completion (Actual)

September 16, 2019

Study Completion (Actual)

September 16, 2019

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 850/2018BO1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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