Frail Elderly SyndromeTRAK-SILVERNCT06381336
A Digital Home-Based Physiotherapy Program for Active Aging
A study testing TRAK-SILVER platform in people with Frail Elderly Syndrome and Older Adults, run by Trak Health Solutions S.L. at 1 site in Spain.
Trial summary
This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Older Adults
- What is being tested?
- TRAK-SILVER platform
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2022to 7 Nov 2022
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being over the age of 65 and living at home (not institutionalized);
- Having a Fried Frailty Index score of 2 points or less.;
- Having a Smartphone, laptop or tablet and having basic knowledge of how to use it or having a person who can help them access and use the platform.
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRAK-SILVER: A Digital Home-Based Physiotherapy Program for Active Aging: a Randomised Controlled Trial.
This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated.
This research will provide insight into the utility and acceptance of the digital platform as a personalised and accessible digital physiotherapy program for this population, advancing understanding in the field.
The participants will undergo a 3-month physiotherapy program using the TRAK-SILVER platform or a paper guide based on their assigned group. Additionally, weekly uploads of health-promoting audiovisual content will enhance the intervention's holistic approach to improving older adults' well-being and functional capacity.
Read the detailed description
The study's recruitment process targets individuals aged 65 and above who live independently in their homes. The social center in Orio, Guipúzcoa, Spain, will serve as a central hub for recruitment. Prospective participants will receive detailed information about the study's requirements, including completing a questionnaire to assess their physical activity levels. They will also be asked to self-report any recent increase in fatigue and weight loss over the preceding month.
After the initial screening, individuals who meet the study's predefined inclusion criteria will be invited to participate. Before enrollment, written informed consent will be obtained from all participants, ensuring ethical compliance and respect for individual autonomy.
The assessment tools used in this study will be comprehensive and systematic, administered both before and after the intervention. The evaluation will cover various metrics, including physical and functional health, mental and emotional well-being, quality of life (QoL), and satisfaction. This approach ensures a thorough evaluation of the intervention's impact on various aspects of the participant's health and well-being.
The study cohort will consist of patients randomly assigned to the experimental group (EG) and the control group (CG). Regardless of group assignment, all patients will undergo baseline health assessments, with the satisfaction questionnaire deferred until post-intervention for both groups.
Participants in the EG will have access to the TRAK-SILVER tool as a fundamental component of the intervention, while participants in the CG will not have such access. Following the intervention phase, which will involve either TRAK-SILVER engagement or adherence to an exercise regimen outlined in a provided sheet, both groups will undergo a new post-intervention assessment, including the satisfaction questionnaire.
The EG will engage in a structured 3-month physiotherapy program comprising 36 60-minute weekly sessions. This program is divided into two distinct phases, each spanning six weeks, with variations in sets and repetitions. Physiotherapists will monitor the sessions using the TRAK-SILVER platform, augmented by weekly phone consultations and email notifications to reinforce engagement.
Each session within the program will include joint mobility exercises, aerobic conditioning, balance training, strength building, and respiratory exercises. Additionally, the platform will feature weekly audiovisual content promoting various aspects of health and well-being to enhance the intervention's efficacy.
In contrast, participants in the CG will receive a printed guide outlining similar recommendations. Adherence to the prescribed regimen will be closely monitored, including session completion rates, post-session pain levels, perceived exertion, and subjective improvement assessments. To enhance adherence, each participant will receive weekly phone calls from supervising physiotherapists.
The study will employ an intention-to-treat analysis approach, incorporating all randomized participants into the final analysis, regardless of their adherence to the intervention protocol. Descriptive statistics, t-tests, and ANCOVA analyses will be utilized to compare changes within and between groups, with statistical significance set at 0.05. Effect sizes will be assessed using Cohen's d.
- Conditions
- Frail Elderly Syndrome, Older Adults
- Being tested
- TRAK-SILVER platform
- Keywords
- telemedicine, active ageing, older people, digital health, pre frail adults, telehealth care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAK-SILVER platformDevice
The Experimental Group used TRAK-SILVER, a cross-platform web application that empowers healthcare professionals and patients. It facilitates the management of a patient's condition by providing therapeutic exercises, monitoring activity, and administering clinical assessment scales and questionnaires. The platform's advanced artificial vision algorithm, known for its precision, enhances patient engagement with real-time measurements and corrections during exercise.
Physiotherapists monitored the sessions through the TRAK-SILVER platform's monitoring system and weekly phone calls. The TRAK-SILVER platform had an alert notification system.
The program's second part involved weekly uploads of health-promoting information pills to the platform.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Use of TRAK-SILVER platform as a treatment methodology. Receives: Device: TRAK-SILVER platform |
| Control Group | No intervention | They did not have access to the platform and were instructed to continue with the standard care program through exercise sheets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB
It is used to classify the participants' physical functioning, with a score below 10 indicating frailty and a high risk of disability or falls.
Measured: up to 3 months
Gait Speed
The Puthoff protocol measured average and maximum gait speed in a six-meter hallway.
Measured: up to 3 months
Timed Up and Go Test
Used to measure the time it took for individuals to stand up from a chair, walk three meters, turn, return to the chair, and sit back down.
Measured: up to 3 months
6-minute walk test (6MWT)
Measure the distance an individual could walk in 6 minutes.
Measured: up to 3 months
Berg Balance Scale
Evaluate balance capacity.
Measured: up to 3 months
Number of steps count
Evaluate walking capacity.
Measured: up to 3 months
Geriatric Depression Scale-15 (GDS)
Assessment mental and emotional well-being. Scores on the GDS range from 0 to 4, indicating the absence of depressive symptoms, while scores from 5 to 8 suggest the presence of mild symptoms.
Measured: up to 3 months
De Jong Gierveld Loneliness Scale (JGLS)
Scores on this scale range from 0 (indicating an absence of loneliness) to 11 (indicating maximum loneliness). To measure the loneliness.
Measured: up to 3 months
Quality of life (QoL) questionnaire
It evaluates health status across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start23 Mar 2022
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized two-group design with pretest-posttest assessment was used to analyse the effectiveness of the TRAK-SILVER application. Seventy-two adults aged 65 and above were stratified by gender and physical functioning capacity (SPBB) and then randomly assigned to either the experimental (EG) or control group (CG). EG received the TRAK-SILVER platform as a treatment methodology. The CG did not have access to the platform and was instructed to continue with the standard care program through exercise sheets.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trak Health Solutions S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Basque Health Service, University of the Basque Country (UPV/EHU)
- Responsible party
- Sponsor
- Investigators
- Asier Arrizabalaga, Principal investigator, Zahartzaroa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381336
- Sponsor's protocol ID
- TRAKSILVER2022
- Acronym
- TRAK-SILVER
- Status last verified
- Dec 2024
- First submitted
- 16 Apr 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAK-SILVER: A Digital Home-Based Physiotherapy Program for Active Aging: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06381336
- Acronym / sponsor ID
- TRAK-SILVER / TRAKSILVER2022
- Conditions
- Frail Elderly Syndrome, Older Adults
- Keywords
- telemedicine, active ageing, older people, digital health, pre frail adults, telehealth care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Trak Health Solutions S.L.Industry (pharma, biotech, devices)
- Collaborators
- Basque Health Service, University of the Basque Country (UPV/EHU)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 24 Apr 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.
This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated.
This research will provide insight into the utility and acceptance of the digital platform as a personalised and accessible digital physiotherapy program for this population, advancing understanding in the field.
The participants will undergo a 3-month physiotherapy program using the TRAK-SILVER platform or a paper guide based on their assigned group. Additionally, weekly uploads of health-promoting audiovisual content will enhance the intervention's holistic approach to improving older adults' well-being and functional capacity.
Detailed description
The study's recruitment process targets individuals aged 65 and above who live independently in their homes. The social center in Orio, Guipúzcoa, Spain, will serve as a central hub for recruitment. Prospective participants will receive detailed information about the study's requirements, including completing a questionnaire to assess their physical activity levels. They will also be asked to self-report any recent increase in fatigue and weight loss over the preceding month.
After the initial screening, individuals who meet the study's predefined inclusion criteria will be invited to participate. Before enrollment, written informed consent will be obtained from all participants, ensuring ethical compliance and respect for individual autonomy.
The assessment tools used in this study will be comprehensive and systematic, administered both before and after the intervention. The evaluation will cover various metrics, including physical and functional health, mental and emotional well-being, quality of life (QoL), and satisfaction. This approach ensures a thorough evaluation of the intervention's impact on various aspects of the participant's health and well-being.
The study cohort will consist of patients randomly assigned to the experimental group (EG) and the control group (CG). Regardless of group assignment, all patients will undergo baseline health assessments, with the satisfaction questionnaire deferred until post-intervention for both groups.
Participants in the EG will have access to the TRAK-SILVER tool as a fundamental component of the intervention, while participants in the CG will not have such access. Following the intervention phase, which will involve either TRAK-SILVER engagement or adherence to an exercise regimen outlined in a provided sheet, both groups will undergo a new post-intervention assessment, including the satisfaction questionnaire.
The EG will engage in a structured 3-month physiotherapy program comprising 36 60-minute weekly sessions. This program is divided into two distinct phases, each spanning six weeks, with variations in sets and repetitions. Physiotherapists will monitor the sessions using the TRAK-SILVER platform, augmented by weekly phone consultations and email notifications to reinforce engagement.
Each session within the program will include joint mobility exercises, aerobic conditioning, balance training, strength building, and respiratory exercises. Additionally, the platform will feature weekly audiovisual content promoting various aspects of health and well-being to enhance the intervention's efficacy.
In contrast, participants in the CG will receive a printed guide outlining similar recommendations. Adherence to the prescribed regimen will be closely monitored, including session completion rates, post-session pain levels, perceived exertion, and subjective improvement assessments. To enhance adherence, each participant will receive weekly phone calls from supervising physiotherapists.
The study will employ an intention-to-treat analysis approach, incorporating all randomized participants into the final analysis, regardless of their adherence to the intervention protocol. Descriptive statistics, t-tests, and ANCOVA analyses will be utilized to compare changes within and between groups, with statistical significance set at 0.05. Effect sizes will be assessed using Cohen's d.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized two-group design with pretest-posttest assessment was used to analyse the effectiveness of the TRAK-SILVER application. Seventy-two adults aged 65 and above were stratified by gender and physical functioning capacity (SPBB) and then randomly assigned to either the experimental (EG) or control group (CG). EG received the TRAK-SILVER platform as a treatment methodology. The CG did not have access to the platform and was instructed to continue with the standard care program through exercise sheets.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: TRAK-SILVER platformUse of TRAK-SILVER platform as a treatment methodology. |
| Control Group | No intervention | –They did not have access to the platform and were instructed to continue with the standard care program through exercise sheets. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being over the age of 65 and living at home (not institutionalized);
- Having a Fried Frailty Index score of 2 points or less.;
- Having a Smartphone, laptop or tablet and having basic knowledge of how to use it or having a person who can help them access and use the platform.
Key exclusion criteria (1 listed)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAK-SILVER platformThe Experimental Group used TRAK-SILVER, a cross-platform web application that empowers healthcare professionals and patients. It facilitates the management of a patient's condition by providing therapeutic exercises, monitoring activity, and administering clinical assessment scales and questionnaires. The platform's advanced artificial vision algorithm, known for its precision, enhances patient engagement with real-time measurements and corrections during exercise. Physiotherapists monitored the sessions through the TRAK-SILVER platform's monitoring system and weekly phone calls. The TRAK-SILVER platform had an alert notification system. The program's second part involved weekly uploads of health-promoting information pills to the platform. | Device | Experimental Group |
Primary outcome
Short Physical Performance Battery (SPPB
Time frame: up to 3 months
It is used to classify the participants' physical functioning, with a score below 10 indicating frailty and a high risk of disability or falls.
Gait Speed
Time frame: up to 3 months
The Puthoff protocol measured average and maximum gait speed in a six-meter hallway.
Timed Up and Go Test
Time frame: up to 3 months
Used to measure the time it took for individuals to stand up from a chair, walk three meters, turn, return to the chair, and sit back down.
6-minute walk test (6MWT)
Time frame: up to 3 months
Measure the distance an individual could walk in 6 minutes.
Berg Balance Scale
Time frame: up to 3 months
Evaluate balance capacity.
Number of steps count
Time frame: up to 3 months
Evaluate walking capacity.
Geriatric Depression Scale-15 (GDS)
Time frame: up to 3 months
Assessment mental and emotional well-being. Scores on the GDS range from 0 to 4, indicating the absence of depressive symptoms, while scores from 5 to 8 suggest the presence of mild symptoms.
De Jong Gierveld Loneliness Scale (JGLS)
Time frame: up to 3 months
Scores on this scale range from 0 (indicating an absence of loneliness) to 11 (indicating maximum loneliness). To measure the loneliness.
Quality of life (QoL) questionnaire
Time frame: up to 3 months
It evaluates health status across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
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 4 Dec 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.
Asier Arrizabalaga principal investigator
Zahartzaroa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAK-SILVER platform in people with Frail Elderly Syndrome and Older Adults, run by Trak Health Solutions S.L. at 1 site in Spain.
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 4 Dec 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 Spain. 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?
Short Physical Performance Battery (SPPB (time frame: up to 3 months). The study lists 9 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 4 Dec 2024.