Cognitive Impairment Clinical Trial
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).
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).
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