A Digital Home-Based Physiotherapy Program for Active Aging (TRAK-SILVER)

December 2, 2024 updated by: Trak Health Solutions S.L.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Basque Country
      • Orio, Basque Country, Spain, 20810
        • Social Center of Orio (Zahartzaroa)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Use of TRAK-SILVER platform as a treatment methodology.
Device: TRAK-SILVER platform

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.
No Intervention: Control Group
They did not have access to the platform and were instructed to continue with the standard care program through exercise sheets.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 3 months
Gait Speed
Time Frame: up to 3 months
The Puthoff protocol measured average and maximum gait speed in a six-meter hallway.
up to 3 months
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.
up to 3 months
6-minute walk test (6MWT)
Time Frame: up to 3 months
Measure the distance an individual could walk in 6 minutes.
up to 3 months
Berg Balance Scale
Time Frame: up to 3 months
Evaluate balance capacity.
up to 3 months
Number of steps count
Time Frame: up to 3 months
Evaluate walking capacity.
up to 3 months
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.
up to 3 months
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.
up to 3 months
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).
up to 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ)
Time Frame: 3 months
Client Satisfaction Questionnaire (CSQ), which comprises eight items with four response options, scoring from 8 to 32, with higher scores indicating greater satisfaction with the treatment.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trak Health Solutions S.L.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of the Basque Country (UPV/EHU)
Basque Health Service

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Asier Arrizabalaga, Zahartzaroa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRAKSILVER2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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