Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06381336 |
| Other study ID # |
TRAKSILVER2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2022 |
| Est. completion date |
November 7, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
Trak Health Solutions S.L. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
