A Digital Home-Based Physiotherapy Program for Active Aging

NCT06381336 | Completed DMC

• 1 other identifier: TRAKSILVER2022
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Frail Elderly Syndrome; Older Adults

Keywords

telemedicine; active ageing; older people; digital health; pre frail adults; telehealth care

Outcome Measures

Primary Outcomes (9)

• 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.

  up to 3 months

• Gait Speed

  The Puthoff protocol measured average and maximum gait speed in a six-meter hallway.

  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.

  up to 3 months

• 6-minute walk test (6MWT)

  Measure the distance an individual could walk in 6 minutes.

  up to 3 months

• Berg Balance Scale

  Evaluate balance capacity.

  up to 3 months

• Number of steps count

  Evaluate walking capacity.

  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.

  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.

  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).

  up to 3 months

Other Outcomes (1)

• Client Satisfaction Questionnaire (CSQ)

  3 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Use of TRAK-SILVER platform as a treatment methodology.

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.

Interventions

TRAK-SILVER platform DEVICE

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.

Experimental Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairment

Sponsors & Collaborators

• Trak Health Solutions S.L.: lead
• Basque Health Service: collaborator
• University of the Basque Country (UPV/EHU): collaborator

Study Sites (1)

Social Center of Orio (Zahartzaroa)

Orio, Basque Country, 20810, Spain

Location

Study Officials

• Asier Arrizabalaga

  Zahartzaroa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 24, 2024
• Study Start: March 23, 2022
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

ES (1)