TelehealthNCT06481384
Validity and Reliability of the Self-administered Timed Up and Go Test: a Promising Telehealth Resource for Monitoring the Risk of Falls in Community-dwelling Older Adults
An observational study of Telehealth, run by Anabela Correia Martins at 1 site in Portugal.
Trial summary
Digital health is an effective solution to overcome logistical and access challenges in urban and rural areas. Telephysiotherapy can play a vital role in tracking and monitoring health and risk factors in older adults.The aim of this study was to determinate the validity and the reliability of the self-administered… Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Telehealth
- How many people
- 37 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Oct 2023to 25 May 2024
- 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 50 to 95 years
- All sexes
- Adult, Older adult
Study population: The participants were adults aged 50 or over, living in the community, who took part in fall risk screening actions advertised in the usual places (municipalities and associations) in the centre of Portugal.
Who may be able to join
- Female and male individuals, aged 50 years or over;
- Residents in the community;
- Present the ability to carry out screenings;
- The individual cannot know the result of the test carried out in person;
- The individual must agree to take the home test;
- Sign to participate in the study and sign the informed consent form.
Who cannot join
- Age less than 50 years old;
- Residing in an institution;
- Not being able or unwilling to give informed consent prior to completing the questionnaire;
- People who demonstrate difficulties in understanding the indications for carrying out functional tests, raising doubts about their cognitive capacity/dementia/ and/or depression;
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Tecnologia da Saúde de Coimbra
Coimbra, 3046-854
About this study
Digital health is an effective solution to overcome logistical and access challenges in urban and rural areas. Telephysiotherapy can play a vital role in tracking and monitoring health and risk factors in older adults.The aim of this study was to determinate the validity and the reliability of the self-administered Timed Up and Go (TUG) test, a gold standard test for fall risk screening, when compared to the traditional face-to-face assessment carried out by a physiotherapist. The protocol included sociodemographic and history of falls questions, the Self-Efficacy for Exercise questionnaire, the Activities and Participation Profile Related to Mobility (PAPM) and three functional tests, namely the 10-Meter Walking Speed (10-MWS) test, TUG test and 30 Seconds Sit to Stand (30s STS) test. Within an interval of 18-24 hours after the face-to-face moment, the participants were invited and instructed to self-administer the TUG test at home.
Read the detailed description
Variable: Self-reported questionnaire The self-report questionnaire included yes/no questions to characterise the sample in terms of sociodemographic and clinical data, history of falls, fear of falling, sedentary behaviours, measured by spending over 4 hours seated, 5 days or more per week, and questions on education level and health self-perception.
Variable: Self-Efficacy for Exercise This 5-item questionnaire intended to analyse the confidence that a person has to perform exercise according to 5 different emotional states, such as feeling worried or having problems, feeling depressed, feeling tired, feeling tense, and being busy.
Variable: Activities and Participation Profile Related to Mobility (PAPM) PAPM is an 18-item scale to assess the difficulties an individual experiences while performing certain daily activities in their natural environment, such as interactions and social relations, education, employment, money management, and social and community life and influence a person's active participation in society. It has a 5-point Likert scale from 0, meaning "no limitation or restriction," to 4, meaning "complete limitation or restriction." In between, 1 indicates "mild limitation or restriction," 2 indicates "moderate limitation or restriction," and 3 indicates "severe limitation or restriction" and since some activities may not apply, not all activities may be rated.
Functional tests Functional capacity was assessed using a set of three tests, also associated with the cited protocol. The 10-Meter Walking Speed (10-MWS) test, 30s Seconds Sit to Stand (30s STS) test and TUG test. These tests assess domains such as gait, balance, functional mobility, lower limb strength and fall risk.
Variable: 10-Meter Walking Speed test The 10-MWS test was used to calculate the speed of accelerated walking, without running, timed over a 10-metre course. This can be useful in identifying those who are at risk or in need of intervention. Performing this test requires a 20-meter course, with 5 meters of acceleration and 5 meters of deceleration and 10 meters for timed walking. Markings are made at 5, 10, 15 and 20 meters and the time between 5 and 15 meters is recorded. The person is instructed to walk at their fastest speed, wearing comfortable footwear and walking aids if necessary.
Variable:30 Seconds Sit to Stand The 30s STS test is a simple instrument used to assess lower limb strength and assess muscle weakness. The person is instructed to perform cycles of sitting and getting up from a chair as many times as possible for 30 seconds. At the end, the number of repetitions is recorded.
Variable: Timed up and Go test The TUG test evaluates dynamic balance, mobility and strength of the lower limbs. The test begins with the person sitting in a standard chair and is instructed to walk a 3-metre course, turn around and return to the chair and sit down, as quickly as possible, without running and without the aid of the upper limbs.
The participants were given a new informed consent to take part in the study and explained its purpose and procedure. Each one was measured in person by the physiotherapist (face-to-face assessment) and at home by the participant (self-administered assessment), 18 to 24 hours apart.
The face-to-face assessment was carried out by a physiotherapist. It should be noted that each participant performed a single TUG test and the result was recorded in seconds, to two decimal places.
The statistical analysis was carried out using IBM SPSS (Statistical Package for the Social Sciences) software, version 29.0.1.0 for Windows. The interpretation of statistical analysis tests was conducted on a significance level of 0.05 (p≤0.05), with a confidence interval of 95%. Pearson´s correlation (r) was used for the analysis of correlations. In the descriptive analysis of the variables, the data was presented according to the mean and standard deviation or percentage, whichever was more appropriate. Pearson´s correlation (r) was used for the analysis of correlations with the values: 0.9-1.0 very strong, 0.70-0.89 strong, 0.40-0.69 moderate, 0.10-0.39 weak and 0.00-0.19 negligible. The data was also presented in terms of its distribution, with a Q-Q graph and T-test for normality. For the TUG test, the minimum clinically acceptable limit of 5 seconds was used, as previously reported.
Firstly, the validity between the self-administered assessment and the simultaneous face-to-face assessment was determined using paired t-tests. For concurrent validity between the self-administered assessment and the separate face-to-face assessment, the Bland and Altman limit of agreement statistic was used. Values that were within the minimum clinically acceptable difference were considered valid and acceptable.
The validity of the assessment carried out by the participant at home was also established by comparing it with the separate face-to-face assessment, using the mean difference of assessments, paired t-tests and intra-class correlation coefficient (ICC).
- Conditions
- Telehealth
- Keywords
- Telephysiotherapy, Self-administered, Timed Up and Go test, Reliability, Validity
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Up and Go Test face-to-face
Seconds
Measured: Day 0
Time Up and Go test self-administered
Seconds
Measured: 18-24 hours after the first measurement
Secondary outcomes (9)
Fear of falling
"Are you afraid of falling?"
Measured: Day 0
History of falls
Falls occurrence 12 months prior to screening. "Did you fall in the past 12 months?"
Measured: Day 0
Sedentary behaviours
"Do you spend more than 4 hours sitting, 5 days a week?"
Measured: Day 0
Education Level
"Basic education (4-9 years)" or "High school (10-12 years)" or "University education"
Measured: Day 0
Health self-perception
"Very good" or "Good" or "Satisfactory" or "Poor"
Measured: Day 0
Self-Efficacy for Exercise
Score 5 to 20 points
Measured: Day 0
Activities and Participation Profile Related to Mobility (PAPM)
Classification: 0, meaning "no limitation or restriction," to 4, meaning "complete limitation or restriction." In between, 1 indicates "mild limitation or restriction," 2 indicates "moderate limitation or restriction," and 3 indicates "severe limitation or restriction"
Measured: Day 0
10- Meter Walking Speed Test
meters per second
Measured: Day 0
30 Seconds Sit to Stand
number os stands
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start10 Oct 2023
- Primary completion25 May 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelehealthStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anabela Correia Martins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anabela Correia Martins, Escola Superior de Tecnologia da Saúde de Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481384
- Sponsor's protocol ID
- 149/2023
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Self-administered Timed Up and Go Test: a Promising Telehealth Resource for Monitoring the Risk of Falls in Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06481384
- Acronym / sponsor ID
- 149/2023
- Conditions
- Telehealth
- Keywords
- Telephysiotherapy, Self-administered, Timed Up and Go test, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Anabela Correia MartinsUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 1 Jul 2024 (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.
Digital health is an effective solution to overcome logistical and access challenges in urban and rural areas. Telephysiotherapy can play a vital role in tracking and monitoring health and risk factors in older adults.The aim of this study was to determinate the validity and the reliability of the self-administered Timed Up and Go (TUG) test, a gold standard test for fall risk screening, when compared to the traditional face-to-face assessment carried out by a physiotherapist. The protocol included sociodemographic and history of falls questions, the Self-Efficacy for Exercise questionnaire, the Activities and Participation Profile Related to Mobility (PAPM) and three functional tests, namely the 10-Meter Walking Speed (10-MWS) test, TUG test and 30 Seconds Sit to Stand (30s STS) test. Within an interval of 18-24 hours after the face-to-face moment, the participants were invited and instructed to self-administer the TUG test at home.
Detailed description
Variable: Self-reported questionnaire The self-report questionnaire included yes/no questions to characterise the sample in terms of sociodemographic and clinical data, history of falls, fear of falling, sedentary behaviours, measured by spending over 4 hours seated, 5 days or more per week, and questions on education level and health self-perception.
Variable: Self-Efficacy for Exercise This 5-item questionnaire intended to analyse the confidence that a person has to perform exercise according to 5 different emotional states, such as feeling worried or having problems, feeling depressed, feeling tired, feeling tense, and being busy.
Variable: Activities and Participation Profile Related to Mobility (PAPM) PAPM is an 18-item scale to assess the difficulties an individual experiences while performing certain daily activities in their natural environment, such as interactions and social relations, education, employment, money management, and social and community life and influence a person's active participation in society. It has a 5-point Likert scale from 0, meaning "no limitation or restriction," to 4, meaning "complete limitation or restriction." In between, 1 indicates "mild limitation or restriction," 2 indicates "moderate limitation or restriction," and 3 indicates "severe limitation or restriction" and since some activities may not apply, not all activities may be rated.
Functional tests Functional capacity was assessed using a set of three tests, also associated with the cited protocol. The 10-Meter Walking Speed (10-MWS) test, 30s Seconds Sit to Stand (30s STS) test and TUG test. These tests assess domains such as gait, balance, functional mobility, lower limb strength and fall risk.
Variable: 10-Meter Walking Speed test The 10-MWS test was used to calculate the speed of accelerated walking, without running, timed over a 10-metre course. This can be useful in identifying those who are at risk or in need of intervention. Performing this test requires a 20-meter course, with 5 meters of acceleration and 5 meters of deceleration and 10 meters for timed walking. Markings are made at 5, 10, 15 and 20 meters and the time between 5 and 15 meters is recorded. The person is instructed to walk at their fastest speed, wearing comfortable footwear and walking aids if necessary.
Variable:30 Seconds Sit to Stand The 30s STS test is a simple instrument used to assess lower limb strength and assess muscle weakness. The person is instructed to perform cycles of sitting and getting up from a chair as many times as possible for 30 seconds. At the end, the number of repetitions is recorded.
Variable: Timed up and Go test The TUG test evaluates dynamic balance, mobility and strength of the lower limbs. The test begins with the person sitting in a standard chair and is instructed to walk a 3-metre course, turn around and return to the chair and sit down, as quickly as possible, without running and without the aid of the upper limbs.
The participants were given a new informed consent to take part in the study and explained its purpose and procedure. Each one was measured in person by the physiotherapist (face-to-face assessment) and at home by the participant (self-administered assessment), 18 to 24 hours apart.
The face-to-face assessment was carried out by a physiotherapist. It should be noted that each participant performed a single TUG test and the result was recorded in seconds, to two decimal places.
The statistical analysis was carried out using IBM SPSS (Statistical Package for the Social Sciences) software, version 29.0.1.0 for Windows. The interpretation of statistical analysis tests was conducted on a significance level of 0.05 (p≤0.05), with a confidence interval of 95%. Pearson´s correlation (r) was used for the analysis of correlations. In the descriptive analysis of the variables, the data was presented according to the mean and standard deviation or percentage, whichever was more appropriate. Pearson´s correlation (r) was used for the analysis of correlations with the values: 0.9-1.0 very strong, 0.70-0.89 strong, 0.40-0.69 moderate, 0.10-0.39 weak and 0.00-0.19 negligible. The data was also presented in terms of its distribution, with a Q-Q graph and T-test for normality. For the TUG test, the minimum clinically acceptable limit of 5 seconds was used, as previously reported.
Firstly, the validity between the self-administered assessment and the simultaneous face-to-face assessment was determined using paired t-tests. For concurrent validity between the self-administered assessment and the separate face-to-face assessment, the Bland and Altman limit of agreement statistic was used. Values that were within the minimum clinically acceptable difference were considered valid and acceptable.
The validity of the assessment carried out by the participant at home was also established by comparing it with the separate face-to-face assessment, using the mean difference of assessments, paired t-tests and intra-class correlation coefficient (ICC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participants were adults aged 50 or over, living in the community, who took part in fall risk screening actions advertised in the usual places (municipalities and associations) in the centre of Portugal.
Key inclusion criteria (6 listed)
- Female and male individuals, aged 50 years or over;
- Residents in the community;
- Present the ability to carry out screenings;
- The individual cannot know the result of the test carried out in person;
- The individual must agree to take the home test;
Key exclusion criteria (4 listed)
- Age less than 50 years old;
- Residing in an institution;
- Not being able or unwilling to give informed consent prior to completing the questionnaire;
- People who demonstrate difficulties in understanding the indications for carrying out functional tests, raising doubts about their cognitive capacity/dementia/ and/or depression;
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
Time Up and Go Test face-to-face
Time frame: Day 0
Seconds
Time Up and Go test self-administered
Time frame: 18-24 hours after the first measurement
Seconds
9 secondary outcomes
Fear of falling
Time frame: Day 0
History of falls
Time frame: Day 0
Sedentary behaviours
Time frame: Day 0
Education Level
Time frame: Day 0
Health self-perception
Time frame: Day 0
Self-Efficacy for Exercise
Time frame: Day 0
Activities and Participation Profile Related to Mobility (PAPM)
Time frame: Day 0
10- Meter Walking Speed Test
Time frame: Day 0
30 Seconds Sit to Stand
Time frame: Day 0
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 1 Jul 2024.
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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 Telehealth, run by Anabela Correia Martins at 1 site in Portugal.
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 6 inclusion and 4 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 1 Jul 2024. 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 Portugal. 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?
Time Up and Go Test face-to-face (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.