Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381336
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-04-16
Brief Title:
A Digital Home-Based Physiotherapy Program for Active Aging
Sponsor:
Trak Health Solutions SL
Organization:
Trak Health Solutions SL
Study Overview
Official Title:
TRAK-SILVER A Digital Home-Based Physiotherapy Program for Active Aging a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAK
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 interventions holistic approach to improving older adults well-being and functional capacity
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 interventions holistic approach to improving older adults well-being and functional capacity
Detailed Description:
The studys 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 studys 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 studys 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 interventions impact on various aspects of the participants 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 interventions 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 005 Effect sizes will be assessed using Cohens d
After the initial screening individuals who meet the studys 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 interventions impact on various aspects of the participants 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 interventions 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 005 Effect sizes will be assessed using Cohens d
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None