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

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ClinicalTrials.gov Identifier: NCT03769220
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Corinna Nerz, Robert Bosch Gesellschaft für Medizinische Forschung mbH

Tracking Information
First Submitted Date December 5, 2018
First Posted Date December 7, 2018
Last Update Posted Date September 26, 2019
Actual Study Start Date December 10, 2018
Actual Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03769220 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 6, 2018)
  • five time Sit to Stand (5xSTS) [ Time Frame: Baseline ]
    needed time for 5 time repeated sit to stand
  • 30 seconds Chair Stand (30s CS) [ Time Frame: Baseline ]
    30 seconds chair stand number of repetitions
  • Gait speed [ Time Frame: Baseline ]
    Gait speed measurement over 7 meters (habitual and fast gait speed), stopped with stopwatch
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Measurement Properties of a 5 Time Repeated Instrumented Timed Up and Go (5iTUG)
Official Title Protocol for the Method Study: Evaluation of the Measurement Properties of an Instrumented and Repeated Timed Up and Go (5iTUG)
Brief Summary 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).
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Measurement Properties of 5iTUG
  • Physical Disability
  • Balance
  • Cognitive Impairment
  • Leg Strength
  • Gait Disorder, Sensorimotor
  • Activity of Daily Living
Intervention Not Provided
Study Groups/Cohorts
  • 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).

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 6, 2018)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date September 16, 2019
Actual Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03769220
Other Study ID Numbers 850/2018BO1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Corinna Nerz, Robert Bosch Gesellschaft für Medizinische Forschung mbH
Study Sponsor Robert Bosch Gesellschaft für Medizinische Forschung mbH
Collaborators Norwegian University of Science and Technology
Investigators Not Provided
PRS Account Robert Bosch Gesellschaft für Medizinische Forschung mbH
Verification Date September 2019