Clinical trial NCT06381336: A Digital Home-Based Physiotherapy Program for Active Aging
Official title: TRAK-SILVER: A Digital Home-Based Physiotherapy Program for Active Aging: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Older Adults
Keywords: telemedicine
active ageing
older people
digital health
pre frail adults
telehealth care
Lead sponsor: Trak Health Solutions S.L.
Sponsor class: INDUSTRY
Collaborators: name: Basque Health Service
name: University of the Basque Country (UPV/EHU)
First posted: 2024-04-24
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Physical Performance Battery (SPPB
timeFrame: up to 3 months
measure: Gait Speed
timeFrame: up to 3 months
measure: Timed Up and Go Test
timeFrame: up to 3 months
measure: 6-minute walk test (6MWT)
timeFrame: up to 3 months
measure: Berg Balance Scale
timeFrame: up to 3 months
measure: Number of steps count
timeFrame: up to 3 months
measure: Geriatric Depression Scale-15 (GDS)
timeFrame: up to 3 months
measure: De Jong Gierveld Loneliness Scale (JGLS)
timeFrame: up to 3 months
measure: Quality of life (QoL) questionnaire
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 3 months
Locations:
city: Orio
country: Spain
facility: Social Center of Orio (Zahartzaroa)
state: Basque Country
Study officials:
affiliation: Zahartzaroa
name: Asier Arrizabalaga
role: PRINCIPAL_INVESTIGATOR
References: