Measurement Properties of 5iTUG5iTUGNCT03769220
Evaluation of the Measurement Properties of a 5 Time Repeated Instrumented Timed Up and Go (5iTUG)
An observational study of Measurement Properties of 5iTUG and Physical Disability, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Measurement Properties of 5iTUG, Physical Disability, Balance
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 10 Dec 2018to 16 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- community-dwelling
- aged between 60 and 80 years
- are able to walk 30m independently
Who cannot join
- any severe cardiovascular, pulmonary, neurological, or mental diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Measurement Properties of 5iTUG, Physical Disability, Balance, Cognitive Impairment, Leg Strength, Gait Disorder, Sensorimotor
- Keywords
- Time up and Go Test
- Medical subject headings
- Cognitive Dysfunction, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
five time repeated instrumented time up and Go Test (5iTUG)
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.
Measured: Baseline
Secondary outcomes (7)
five time Sit to Stand (5xSTS)
needed time for 5 time repeated sit to stand
Measured: Baseline
30 seconds Chair Stand (30s CS)
30 seconds chair stand number of repetitions
Measured: Baseline
Gait speed
Gait speed measurement over 7 meters (habitual and fast gait speed), stopped with stopwatch
Measured: Baseline
Community Balance and Mobility Scale (CBMS)
Community Balance and Mobility Scale, Score range from 0-96 points (with 96 is the best performance), duration: 35 minutes
Measured: Baseline
8-level balance score
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
Measured: Baseline
Short Physical Performance Battery (SPPB)
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
Measured: Baseline
Late Life Function and Disability questionnaire for Function (LLFDI)
Late Life Function and Disability (LLFDI) questionnaire, subjective measurement of functional ability and disability, scale range 0-100 points, higher points indicate better performance
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start10 Dec 2018
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Measurement Properties of 5iTUGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Corinna Nerz, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769220
- Sponsor's protocol ID
- 850/2018BO1
- Acronym
- 5iTUG
- Status last verified
- Sep 2019
- First submitted
- 5 Dec 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Studenski S, Perera S, Wallace D, Chandler JM, Duncan PW, Rooney E, Fox M, Guralnik JM. Physical performance measures in the clinical setting. J Am Geriatr Soc. 2003 Mar;51(3):314-22. doi: 10.1046/j.1532-5415.2003.51104.x.
PubMed 12588574Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946Schoene D, Wu SM, Mikolaizak AS, Menant JC, Smith ST, Delbaere K, Lord SR. Discriminative ability and predictive validity of the timed up and go test in identifying older people who fall: systematic review and meta-analysis. J Am Geriatr Soc. 2013 Feb;61(2):202-8. doi: 10.1111/jgs.12106. Epub 2013 Jan 25.
PubMed 23350947Mellone S, Tacconi C, Chiari L. Validity of a Smartphone-based instrumented Timed Up and Go. Gait Posture. 2012 May;36(1):163-5. doi: 10.1016/j.gaitpost.2012.02.006. Epub 2012 Mar 14.
PubMed 22421189
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Method Study: Evaluation of the Measurement Properties of an Instrumented and Repeated Timed Up and Go (5iTUG)
- ClinicalTrials.gov ID
- NCT03769220
- Acronym / sponsor ID
- 5iTUG / 850/2018BO1
- Conditions
- Measurement Properties of 5iTUG, Physical Disability, Balance, Cognitive Impairment, Leg Strength, Gait Disorder, Sensorimotor
- Keywords
- Time up and Go Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- community-dwelling
- aged between 60 and 80 years
- are able to walk 30m independently
Key exclusion criteria (1 listed)
- any severe cardiovascular, pulmonary, neurological, or mental diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
five time Sit to Stand (5xSTS)
Time frame: Baseline
30 seconds Chair Stand (30s CS)
Time frame: Baseline
Gait speed
Time frame: Baseline
Community Balance and Mobility Scale (CBMS)
Time frame: Baseline
8-level balance score
Time frame: Baseline
Short Physical Performance Battery (SPPB)
Time frame: Baseline
Late Life Function and Disability questionnaire for Function (LLFDI)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 12588574Studenski S, Perera S, Wallace D, Chandler JM, Duncan PW, Rooney E, Fox M, Guralnik JM. Physical performance measures in the clinical setting. J Am Geriatr Soc. 2003 Mar;51(3):314-22. doi: 10.1046/j.1532-5415.2003.51104.x.
- Background: PubMed 1991946Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- Background: PubMed 23350947Schoene D, Wu SM, Mikolaizak AS, Menant JC, Smith ST, Delbaere K, Lord SR. Discriminative ability and predictive validity of the timed up and go test in identifying older people who fall: systematic review and meta-analysis. J Am Geriatr Soc. 2013 Feb;61(2):202-8. doi: 10.1111/jgs.12106. Epub 2013 Jan 25.
- Background: PubMed 22421189Mellone S, Tacconi C, Chiari L. Validity of a Smartphone-based instrumented Timed Up and Go. Gait Posture. 2012 May;36(1):163-5. doi: 10.1016/j.gaitpost.2012.02.006. Epub 2012 Mar 14.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measurement Properties of 5iTUG and Physical Disability, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
five time repeated instrumented time up and Go Test (5iTUG) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03769220, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.