Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558591
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
Feasibility and Potential Impact of an Individualized Exercise Program Via a Telerehabilitation Device in Chronic Patients A Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Potential Impact of an Individualized Exercise Program Via a Telerehabilitation Device in Chronic Patients A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Exercise Rehabilitation ER is widely used and effective in the treatment of chronic diseases however patients do not adhere to ER programs Tele-rehabilitation is effective and often used to support and improve patient adherence Thus the ADEPINA device could be a promising solution for the individualized management of patients by their therapists The aim of the study will be a To assess functional improvement measured by the 6-minute walk test 6MWT after the 12 weeks ER program in people with chronic disease Additionally the study will assess the individualized program adherence and his effect on patients physical fitness and quality of life Methods Fifty patients will follow individualized ER sessions to their patients with chronic diseases using the ADEPINA device 2 to 3 times per week for 12 weeks At the end of the intervention the investigator will assess patients lower limb strength with sit to stand test dynamic balance Timed up and go test patients adherence to the ER program by evaluating the usage time of the system by participants the treatment credibility and participant expectations for improvement will be assessed with the French version of the Credibility and Expectancy Questionnaire The investigator will also evaluate the patients quality of life using the World Health Organization Quality of Life WHOQOL scale at the beginning and end of the intervention Discussion This interventional pilot study could have positive impacts for participants and explore gaps in the current literature regarding the individualized telerehabilitation program feasibility
Detailed Description:
The ADEPINA project is a 12- week prospective multicentric pilot study The project will be conducted by the HAVAE laboratory and the Limoges university will be the promoter The study protocol is in accordance with the Standard Protocol Items Recommendations for Interventional Trials SPIRIT guidelines Patients will perform ER program proposed by their professionals as part of their routine care through ADEPINA web platform for 12 weeks with evaluations before and after the intervention
Participants recruitment
The principal investigator will recruit ER therapists working in the private sector public sector or both The investigator will present the study to potential participants This study will be conducted with ER professionals physiotherapists kinesiologists and their patients with chronic conditions Volunteers who meet the inclusion criteria below and provide written consent will be included and will then receive an information notice
Inclusion will take place within the framework of routine care for individuals with chronic diseases in rehabilitation services hospitals institutions etc The study will be offered to patients with chronic conditions who are being cared for by their therapists Data collection will be conducted in two sessions The period between the two sessions will be determined based on the patients availability not exceeding a period of 12 weeks
1 1st session at Day 0 Conducting activities and initial evaluation at their usual care center Therapists will perform the various planned tests and evaluations
2 2nd session at 12 weks This session will take place under the same conditions as the first one and without any potential health risks to the participants
3 A final follow up session will be carried out at 18 weeks A telephone call will be made between the two sessions to check in and assist participants both therapists and patients with chronic illnesses in case of any issues during the study Recruitment will be coordinated by the clinical investigation center of the University Hospital of Limoges
Eligibility
Participants must meet the following criteria before being included in the present study Professionals must a Be a physiotherapist or kinesiologist working in the public sector private sector or in a mixed capacity b Have been graduated for at least one year c Conduct RE with their patients and provide written consent
The patients of the professionals included in the study must a Be 18 years of age or older b Be capable of giving informed consent c Be registered with the French social security system e Be under the care of a rehabilitation exercise professional
Non inclusion criteria We will not include patients who a Have an intolerance or inability to use digital tools b Have a cognitive impairment c Have contraindications to physical activity unstable diabetes unstable hypertension unstable angina intracardiac thrombus In addition we will not include professionals who refuse to participate in the study
Exclusion Criteria Participants will be excluded from the study if a They patients or professionals withdraw their consent to participate in this study during or after data collection b A serious adverse event occurs to a patient being treated by a professional included in the study deterioration of the participants health fall injury All participants who request to leave the study will be excluded Similarly participants who do not use the platform before the final evaluation after two reminders will be excluded from this study and the final analysis
Sample size calculation
The sample size calculation is based on a previous study by Hwang et al that assessed efficacy and safety of a group-based heart failure rehabilitation program delivered into each participants home via an online telerehabilitation system Investigators hypothesized that the 12 weeks telerehabilitation program would improve the attendance rates among patients after the intervention by 10 In addition a personalized telerehabilitation program could improve clinical parameters such as physical conditions Timed up and go sit to stand tests and quality of life Investigators performed an estimation with 080 power and 005 α risk The sample size required was 35 patients Investigators added 20 to ensure the statistical power of the study considering possible drop-out The total sample will consist in 50 patients
Ethical approval and considerations
All procedures will follow the recommendations of the Good Clinical Practice Guidelines of the Declaration of Helsinki This project will receive authorization from the ethics and individual protection committee IFC sud-est 2 Every significant amendment to the protocol will have to be approved by the Committee prior to its implementation The study will also follow the principles of the Declaration of Helsinki The results of the current study will be published in relevant scientific journals and be disseminated in international conferences The consent form and the information notice will be drawn up in triplicate one copy of which will be given to each participant This study is part of routine care and people with chronic diseases will be cared for in accordance with their usual care plan Finally the risks associated with this study are very low because considering the jardé law in effect in France this is interventional research on the human person with minor risk RIPH3
Intervention
ADEPINA device
i Web-based Platform Therapists will create physical training sessions by compiling exercises into video capsules for the patients Patients will find these sessions in their personal spaces and will perform the same movements requested by the therapist adhering to safety instructions and the prescribed dosage repetitions sets etc Therapists will use equipment regularly utilized in routine care
ii Android Tablet All patients will have access to a tablet that allows them to view the sessions from their respective caregivers They can also perform physical fitness tests by following the therapists instructions
iii Wearable Sensor The evaluation of physical activity levels is conducted using tools from the wearable sensor which includes MEMS components commonly found in smartwatches and mobile phones accelerometer gyrometer magnetometer Participants will need to wear the sensor on their wrist during evaluations Sit to stand TUG etc
Training program We conceptualized our telerehabilitation device based on our previous studies regarding the acceptability of the ADEPINA device According to previous studies patients prefer their care to be provided by their healthcare professionals Therefore rehabilitation exercise professionals have the opportunity to design their own personalized rehabilitation exercise sessions for their patients These professionals are required to adhere to the World Health Organization WHO recommendations regarding the design of rehabilitation exercise sessions
Outcomes and Evaluations
Primary outcomes Over a 12-weeks period participants will use the digital platform for their regular rehabilitation exercise sessions This will be a pilot study based on the collection and analysis of quantitative data The study will investigate the functional improvement measured by the 6-minute walk test 6MWT after the 12 weeks ER program in people with chronic disease
Secondary outcomes
In addition the study will assess
The adherence to the rehabilitation exercise program will be assessed by evaluating the system usage time by participants professionals and their patients Specifically we will examine program adherence through the rate of professionals and patients who completed the intervention and both evaluations at Day 0 Week 12 and Week 18
Lower limb muscles strength using the Sit-to-Stand Test STS Participants will be instructed to stand up completely and then sit down on a chair with their back against the backrest as quickly as possible within 30 seconds while keeping their arms crossed over their chest The number of repetitions performed during the 30-second STS test will be simultaneously recorded by our custom sensor which was validated in our recent study Performance on the STS test is associated with disability fall risk hip fractures and mortality among elderly individuals and those with chronic diseases
Quality of life will be assessed using the World Health Organization Quality of Life WHOQOL questionnaire
Patients dynamic balance using the Timed Up and Go TUG test assesses functional mobility and dynamic balance in individuals The subject rises from a chair walks a distance of 3 meters turns around walks back and sits down Participants will be instructed to sit upright in the chair hands on thighs and back against the chairs backrest Once the wearable sensor gives the starting signal they will rise from the chair walk at their normal pace turn around just after passing the 3-meter mark walk back and sit down again The test duration will be measured by our custom sensor which was also validated in our recent study
The treatment credibility and participant expectations for improvement will be assessed with the French version of the Credibility and Expectancy Questionnaire CEQ
The CEQ includes a Credibility subscale 3 items and an Expectancy subscale 3 items The Credibility subscale has a 1-9 rating scale 1 not at all to 9 very for a total sub-score ranging from 3 to 27 The Expectancy scale has a 0-100 scale and item 2 has a 1-9 rating scale for a total sub-score ranging from 3 to 27 after transforming the percentage scales A moderate score ranges between 1350 and 2025 scores above 2025 are considered high
Statistical analysis
Descriptive statistics including frequencies percentages median and interquartile range will be performed to examine the characteristics of the participants For the qualitative part a thematic analysis will be carried out to identify the salient aspects of health professionals experiences and opinions regarding the ADEPINA device At the end of the intervention the average usability rate and the attractiveness of the platform to professionals and their patients will be assessed We will compare clinical parameters before and after training between Day 0 and week 12 using either the paired students t test or the non-parametric Mann- Whitney test depending on whether the data follow a normal distribution Data will be analyzed with an analysis of variance between Day 0 Week 12 and week 18
All participants will be included in the analysis intention-to-treat analysis The quantitative analysis will be performed using SPSS V23003 IBM SPSS Statistics and qualitative analysis will be performed by XLSTAT 16 software The threshold of significance for all tests will be 005
Participants recruitment
The principal investigator will recruit ER therapists working in the private sector public sector or both The investigator will present the study to potential participants This study will be conducted with ER professionals physiotherapists kinesiologists and their patients with chronic conditions Volunteers who meet the inclusion criteria below and provide written consent will be included and will then receive an information notice
Inclusion will take place within the framework of routine care for individuals with chronic diseases in rehabilitation services hospitals institutions etc The study will be offered to patients with chronic conditions who are being cared for by their therapists Data collection will be conducted in two sessions The period between the two sessions will be determined based on the patients availability not exceeding a period of 12 weeks
1 1st session at Day 0 Conducting activities and initial evaluation at their usual care center Therapists will perform the various planned tests and evaluations
2 2nd session at 12 weks This session will take place under the same conditions as the first one and without any potential health risks to the participants
3 A final follow up session will be carried out at 18 weeks A telephone call will be made between the two sessions to check in and assist participants both therapists and patients with chronic illnesses in case of any issues during the study Recruitment will be coordinated by the clinical investigation center of the University Hospital of Limoges
Eligibility
Participants must meet the following criteria before being included in the present study Professionals must a Be a physiotherapist or kinesiologist working in the public sector private sector or in a mixed capacity b Have been graduated for at least one year c Conduct RE with their patients and provide written consent
The patients of the professionals included in the study must a Be 18 years of age or older b Be capable of giving informed consent c Be registered with the French social security system e Be under the care of a rehabilitation exercise professional
Non inclusion criteria We will not include patients who a Have an intolerance or inability to use digital tools b Have a cognitive impairment c Have contraindications to physical activity unstable diabetes unstable hypertension unstable angina intracardiac thrombus In addition we will not include professionals who refuse to participate in the study
Exclusion Criteria Participants will be excluded from the study if a They patients or professionals withdraw their consent to participate in this study during or after data collection b A serious adverse event occurs to a patient being treated by a professional included in the study deterioration of the participants health fall injury All participants who request to leave the study will be excluded Similarly participants who do not use the platform before the final evaluation after two reminders will be excluded from this study and the final analysis
Sample size calculation
The sample size calculation is based on a previous study by Hwang et al that assessed efficacy and safety of a group-based heart failure rehabilitation program delivered into each participants home via an online telerehabilitation system Investigators hypothesized that the 12 weeks telerehabilitation program would improve the attendance rates among patients after the intervention by 10 In addition a personalized telerehabilitation program could improve clinical parameters such as physical conditions Timed up and go sit to stand tests and quality of life Investigators performed an estimation with 080 power and 005 α risk The sample size required was 35 patients Investigators added 20 to ensure the statistical power of the study considering possible drop-out The total sample will consist in 50 patients
Ethical approval and considerations
All procedures will follow the recommendations of the Good Clinical Practice Guidelines of the Declaration of Helsinki This project will receive authorization from the ethics and individual protection committee IFC sud-est 2 Every significant amendment to the protocol will have to be approved by the Committee prior to its implementation The study will also follow the principles of the Declaration of Helsinki The results of the current study will be published in relevant scientific journals and be disseminated in international conferences The consent form and the information notice will be drawn up in triplicate one copy of which will be given to each participant This study is part of routine care and people with chronic diseases will be cared for in accordance with their usual care plan Finally the risks associated with this study are very low because considering the jardé law in effect in France this is interventional research on the human person with minor risk RIPH3
Intervention
ADEPINA device
i Web-based Platform Therapists will create physical training sessions by compiling exercises into video capsules for the patients Patients will find these sessions in their personal spaces and will perform the same movements requested by the therapist adhering to safety instructions and the prescribed dosage repetitions sets etc Therapists will use equipment regularly utilized in routine care
ii Android Tablet All patients will have access to a tablet that allows them to view the sessions from their respective caregivers They can also perform physical fitness tests by following the therapists instructions
iii Wearable Sensor The evaluation of physical activity levels is conducted using tools from the wearable sensor which includes MEMS components commonly found in smartwatches and mobile phones accelerometer gyrometer magnetometer Participants will need to wear the sensor on their wrist during evaluations Sit to stand TUG etc
Training program We conceptualized our telerehabilitation device based on our previous studies regarding the acceptability of the ADEPINA device According to previous studies patients prefer their care to be provided by their healthcare professionals Therefore rehabilitation exercise professionals have the opportunity to design their own personalized rehabilitation exercise sessions for their patients These professionals are required to adhere to the World Health Organization WHO recommendations regarding the design of rehabilitation exercise sessions
Outcomes and Evaluations
Primary outcomes Over a 12-weeks period participants will use the digital platform for their regular rehabilitation exercise sessions This will be a pilot study based on the collection and analysis of quantitative data The study will investigate the functional improvement measured by the 6-minute walk test 6MWT after the 12 weeks ER program in people with chronic disease
Secondary outcomes
In addition the study will assess
The adherence to the rehabilitation exercise program will be assessed by evaluating the system usage time by participants professionals and their patients Specifically we will examine program adherence through the rate of professionals and patients who completed the intervention and both evaluations at Day 0 Week 12 and Week 18
Lower limb muscles strength using the Sit-to-Stand Test STS Participants will be instructed to stand up completely and then sit down on a chair with their back against the backrest as quickly as possible within 30 seconds while keeping their arms crossed over their chest The number of repetitions performed during the 30-second STS test will be simultaneously recorded by our custom sensor which was validated in our recent study Performance on the STS test is associated with disability fall risk hip fractures and mortality among elderly individuals and those with chronic diseases
Quality of life will be assessed using the World Health Organization Quality of Life WHOQOL questionnaire
Patients dynamic balance using the Timed Up and Go TUG test assesses functional mobility and dynamic balance in individuals The subject rises from a chair walks a distance of 3 meters turns around walks back and sits down Participants will be instructed to sit upright in the chair hands on thighs and back against the chairs backrest Once the wearable sensor gives the starting signal they will rise from the chair walk at their normal pace turn around just after passing the 3-meter mark walk back and sit down again The test duration will be measured by our custom sensor which was also validated in our recent study
The treatment credibility and participant expectations for improvement will be assessed with the French version of the Credibility and Expectancy Questionnaire CEQ
The CEQ includes a Credibility subscale 3 items and an Expectancy subscale 3 items The Credibility subscale has a 1-9 rating scale 1 not at all to 9 very for a total sub-score ranging from 3 to 27 The Expectancy scale has a 0-100 scale and item 2 has a 1-9 rating scale for a total sub-score ranging from 3 to 27 after transforming the percentage scales A moderate score ranges between 1350 and 2025 scores above 2025 are considered high
Statistical analysis
Descriptive statistics including frequencies percentages median and interquartile range will be performed to examine the characteristics of the participants For the qualitative part a thematic analysis will be carried out to identify the salient aspects of health professionals experiences and opinions regarding the ADEPINA device At the end of the intervention the average usability rate and the attractiveness of the platform to professionals and their patients will be assessed We will compare clinical parameters before and after training between Day 0 and week 12 using either the paired students t test or the non-parametric Mann- Whitney test depending on whether the data follow a normal distribution Data will be analyzed with an analysis of variance between Day 0 Week 12 and week 18
All participants will be included in the analysis intention-to-treat analysis The quantitative analysis will be performed using SPSS V23003 IBM SPSS Statistics and qualitative analysis will be performed by XLSTAT 16 software The threshold of significance for all tests will be 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None