Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491121
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-05-29
Brief Title:
Technology Supported High Intensity Training in Chronic Low Back Pain the Techno-HIT Trial
Sponsor:
Hasselt University
Organization:
Hasselt University
Study Overview
Official Title:
Technology Supported High Intensity Training in Chronic Low Back Pain the Techno-HIT Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
TECHNO-HIT
Brief Summary:
Chronic low back pain CLBP is one of the most common chronic musculoskeletal disorder worldwide and is responsible for the highest levels of disability of all diseases All state-of-the-art guidelines recommend implementing exercise therapy ET in CLBP management Researchers have shown that a novel ET modality namely high intensity training HIT can be valuable A clinical evaluation study in a larger spectrum of persons with CLBP in a rehabilitation centre setting is essential Thereby technology might support HIT
The primary goal of this clinical trial is to evaluate the short- and long-term effectiveness of a time contingent individualized High intensity training HIT protocol on disability compared to moderate intensity training MIT in persons with severely disabling chronic low back pain CLBP Secondary goals entail 1 evaluating short- and long-term effectiveness of HIT on psychosocial correlates central pain processing and broad physical fitness 2 investigating additional effects of prolonged HIT at home 3 investigating added value of technology through a mobile smartphone and dashboard computer application that offers support during home training 4 evaluating cost-effectiveness of technology supported HIT compared to MIT The main research questions RQ it aims to answer are
RQ1 To what extent is HIT effective on the short- and long term to improve disability in persons with severely disabling CLBP compared to MIT as used in usual care
RQ2a To what extent does HIT have a short- andor long-term effect on central pain processing and psychosocial correlates in persons with severely disabling CLBP
RQ2bTo what extent does HIT have a short- andor long-term effect on outcomes related to broad physical fitness in persons with severely disabling CLBP
RQ3a To what extent does prolonged technology-supported HIT at home provide additional training effects in persons with severely disabling CLBP
RQ3bTo what extent does a mobile application that offers support for HIT at home provide added value for treatment outcomes of persons with severely disabling CLBP
RQ3cTo what extent is the techno-HIT application usable and qualitative assessed by SUS and uMARS as a therapeutic support mechanism as evaluated by persons with severely disabling CLBP
RQ4 To what extent is HIT or HIT supported by a mobile application cost effective compared to MIT for patients with severely disabling CLBP
The primary goal of this clinical trial is to evaluate the short- and long-term effectiveness of a time contingent individualized High intensity training HIT protocol on disability compared to moderate intensity training MIT in persons with severely disabling chronic low back pain CLBP Secondary goals entail 1 evaluating short- and long-term effectiveness of HIT on psychosocial correlates central pain processing and broad physical fitness 2 investigating additional effects of prolonged HIT at home 3 investigating added value of technology through a mobile smartphone and dashboard computer application that offers support during home training 4 evaluating cost-effectiveness of technology supported HIT compared to MIT The main research questions RQ it aims to answer are
RQ1 To what extent is HIT effective on the short- and long term to improve disability in persons with severely disabling CLBP compared to MIT as used in usual care
RQ2a To what extent does HIT have a short- andor long-term effect on central pain processing and psychosocial correlates in persons with severely disabling CLBP
RQ2bTo what extent does HIT have a short- andor long-term effect on outcomes related to broad physical fitness in persons with severely disabling CLBP
RQ3a To what extent does prolonged technology-supported HIT at home provide additional training effects in persons with severely disabling CLBP
RQ3bTo what extent does a mobile application that offers support for HIT at home provide added value for treatment outcomes of persons with severely disabling CLBP
RQ3cTo what extent is the techno-HIT application usable and qualitative assessed by SUS and uMARS as a therapeutic support mechanism as evaluated by persons with severely disabling CLBP
RQ4 To what extent is HIT or HIT supported by a mobile application cost effective compared to MIT for patients with severely disabling CLBP
Detailed Description:
This RCT includes a total sample size of n168 persons with chronic low back pain CLBP randomly divided into three groups of each 56 participants Group 1 TechnoHIT Group 2 HIT Group 3 MIT For each group the trial involves a 24-week exercise intervention with a total of 52 rehabilitation sessions 4 educational sessions in the biopsychosocial program in the first two weeks and two physical therapy sessions each week n48 in total in three phases 2 therapy phases and 1 follow- up phase The first therapy phase consists of 12 weeks and is performed in the hospitals Jessa and UZA under supervision of PhD-students with a physiotherapy background that are members of the FWO TECHNOHIT consortium and clinical study assistants with a physiotherapy background The second therapy phase consists of 12 weeks and is performed in the home setting of the participant The follow-up phase only consists of advice towards continuation of physical activity and app logging or no contact based on group randomization The first follow-up visit is planned directly after the last treatment session in the hospital The second follow-up visit will take place 3 months after the last treatment session shortly after the last at-home session The last two follow-up visits will take place 6 and 18 months after the last at-home session
Patients with CLBP who present themselves at UZAJessa for consultation and start-up of a rehabilitation program ie within the Belgian reimbursement system for medical treatments defined as a K60 programma Ambulante multidisciplinaire revalidatiezitting met een minimumduur van 120 minuten voor een wervelzuilaandoening who ought to be eligible for the study by the physician who meet the inclusion criteria will be informed about this study by the physician If they are interested a study flyer and an approval form for further contact will be issued by the physician The form is signed by the patient and returned The researchers will contact the potential participant within a period of two to seven days answer initial questions review the inclusion criteria and provide the informed consent onlinehard copy according to the preference of the potential participant Patients who sign and return the informed consent within two weeks will be contacted for possible enrolment
This study will start recruitment in January 2024 and have an active intervention phase of three years The end of the recruitment phase is therefore planned around January 2027 After the recruitment phase a period of six months is reserved for final data analysis and scientific publication writing The total duration of this study is therefore 35 years the end of the study is expected around August 2027
Pre-phase biopsychosocial education program 4 sessions T-1-T0
Four sessions with educational content 60 minsession 2xweek will be organized at the hospitals at the start of the intervention for all groups This educational content relates to a pain educationdealing with pain b ergonomics c activity management and optimizing the working and social environment and d neurophysiology of pain These sessions will be provided by the PhD students The content of this education program is based on scientific research and publications on patient education from renowned organizations such as retrainpainorg and pain in motion and on extensive work previously done by members of the consortium The content will be standardized between the test centers UZA and Jessa
Phase 1 intervention at the hospital facility 24 sessions week 1-12 T0-T1 The three groups will follow a 12-week training program in which a time contingent approach is used as proposed by recent clinical practice guidelines To limit performance bias each group will train separately and will not be able to evaluate differences between the therapies
Group 1 TechnoHIT and group 2 HIT - These groups will perform 15h exercise therapy sessions twice a week comprising of a combination of cardiorespiratory interval general resistance and core muscle strength training all at high intensity according to a previously published protocol by our research group Briefly cardiorespiratory training consists of an interval protocol on a cycle ergo-meter consisting of five one-minute 100 VO2max workload bouts separated by one minute of active rest at 50 VO2max workload 100 VO2max bouts increase every two sessions by 10 Active rest remains stable This protocol is repeated from session 13 to 24 with an updated workload 5 WMax General resistance training consists of three upper body and three lower body exercises executed on fitness equipment performed at 80 of the one repetition maximum Core muscle strength training consists of six static core exercises and related progressions Exercises were chosen in function of their ability to load the core muscles at an intensity of 60 of the maximum voluntary contraction
Group 3 MIT control group - This group will perform 15h exercise therapy sessions twice a week of cardiorespiratory continuous load general resistance and core muscle training all at moderate intensity according to a previously published protocol by our research team Briefly cardiorespiratory training consists of a continuous training protocol on a cycle ergometer Participants start with 14 minutes of cycling 90 repetitions per minute at 60VO2max workload Duration will be increased every two sessions with 140 up to 2240 This protocol is repeated from session 13 to 24 with an updated workload 5 WMax General resistance training is identical to the protocol described in HIT with the exception of the exercise intensity exercises are performed here at 60 of 1RM Core muscle strength training is identical to the protocol described in HIT with the exception of the exercise intensity Participants perform one set of ten repetitions of a ten second static hold Exercises are made more difficult when they were executed with a stable core posture for the indicated time by increasing the time of the static hold each six sessions
Phase 2 intervention at home 24 sessions week 13-24 T1-T2 The three groups will follow a comparable 12-week training program as phase 1 but in their home setting The participants of group 1 will be supported by a mobile application on their phone The participants of group 1 2 will be provided with a fitness bike a smartwatch Polar M200 and training mat during the execution of this phase Sessions missed by the participants because of adverse events eg acute increase of low back pain acute musculoskeletal issues due to exercises will be registered
Group 1 TECHNO-HIT - Participants in this group receive an exercise schedule via the TechnoHIT mobile application a home trainer E50 Tunturi Fitness a heartrate sensor H10 Polara and smartwatch Ignite Polar and a training mat for the duration of this phase They are asked to perform a 60 min home program twice a week containing cardiorespiratory and core muscle strength training both at high intensity HIT protocol methods are equal to those in Phase 1 The training sessions of these patients are guided by the mobile application The user reports performes exercises in the mobile application that keeps track of their progress calculates compliance with the program and gives motivational feedback based on the patients performance and adherence
Group 2 HIT - Participants in this group receive an exercise schedule on paper a home trainer ie fitness bike and a training mat for the duration of this phase They are asked to perform a one-hour home program twice a week containing cardiorespiratory and core muscle strength training both at high intensity They also receive a diary to log their training sessions
Group 3 MIT control group - Participants in this group receive an exercise schedule on paper They are asked to perform a one-hour home program twice a week containing cardiorespiratory and core muscle training both at moderate intensity They also receive a diary to log their training sessions As we decided not to provide a bicycle and exercise mat in order to match the therapy as usual setting cardiorespiratory training in this phase will be based on a brisk walking modality performed at the same moderate exercise intensity and matched for training volume
The Techno-HIT home-training system consists of the following components and main functionalities
a mobile application for the patients at home to receive the HIT training program to schedule the training in sessions over the week to receive reminders and notifications to see the overall HIT training program or get more details on exercises and performed sessions to have access to exercise instructions to get guidance by the app while performing the exercises to get motivational feedback after performing the exercise and reporting the status to get feedback about progress and adherence to select a strategy to improve the adherence to report a variety of activities beyond the HIT program etc
a dashboard application for the physiotherapists researchers to see an overview of notifications about the patients training status to search through patient files and notifications to manage patient groups to provide the info on the HIT training to update exercise parameters to follow-up on the patients progress and view aggregated visual representations of progress to send hints to the patients to follow system suggestions for a progression or regression to give feedback to patients Some functionalities are admin functionalities and require an authorized account eg to create new patient files to manage caregiver accounts etc
Participants perform two assessments at baseline T-1 PRE before psychosocial education T0 PRE after psychosocial education and 4 longitudinal assessment T1 MID after a 12-week program in-hospital T2 POST after a 12-week program at home T3 POST 6 month follow-up T4 POST 18 month follow-up consisting of both physical testings and filling in health and disease related questionnaires At T-1 the assessments have a duration of approximately 2 hours 90min questionnaires 30min QST measurements During this assessment sociodemographic data of the participant will also be collected At T0 physical assessments will be added aswell as additional questionnaires T0 will have a duration of approximately 3 hours At T1 T2 T3 and T4 additional questionnaires will be added increasing the duration to 3 hours and 40 minutes
A rater cross-over assessment protocol will be used to ensure blinding of assessors All assessments are carried out by trained PhD-students and postdoctoral researchers that are part of the FWO Techno-HIT Trial project in the specialized movement and pain assessment labs of REVAL UHasselt and MOVANT UAntwerpen see section outcomes for detailed information on the depicted outcome measures
All data is treated confidentially and encrypted during the execution of the tests HIT-TECH followed by a timing letternumber T-1 A T00 T11 T22 T33 T44 and a sequence number 01 to 15 To associate the data with the subjects during data analysis a subject identification list 0-15 randomized is used The identification and key of the code is monitored by an independent researcher who is not involved in the research All data collected is stored in the Google Drive UHasseltMicrosoft Teams UAntwerp file stream and only members of the research team with a university account and password can access the source data Source data is kept for 25 years in accordance with GCP standards for reuse or for results validation
Patients with CLBP who present themselves at UZAJessa for consultation and start-up of a rehabilitation program ie within the Belgian reimbursement system for medical treatments defined as a K60 programma Ambulante multidisciplinaire revalidatiezitting met een minimumduur van 120 minuten voor een wervelzuilaandoening who ought to be eligible for the study by the physician who meet the inclusion criteria will be informed about this study by the physician If they are interested a study flyer and an approval form for further contact will be issued by the physician The form is signed by the patient and returned The researchers will contact the potential participant within a period of two to seven days answer initial questions review the inclusion criteria and provide the informed consent onlinehard copy according to the preference of the potential participant Patients who sign and return the informed consent within two weeks will be contacted for possible enrolment
This study will start recruitment in January 2024 and have an active intervention phase of three years The end of the recruitment phase is therefore planned around January 2027 After the recruitment phase a period of six months is reserved for final data analysis and scientific publication writing The total duration of this study is therefore 35 years the end of the study is expected around August 2027
Pre-phase biopsychosocial education program 4 sessions T-1-T0
Four sessions with educational content 60 minsession 2xweek will be organized at the hospitals at the start of the intervention for all groups This educational content relates to a pain educationdealing with pain b ergonomics c activity management and optimizing the working and social environment and d neurophysiology of pain These sessions will be provided by the PhD students The content of this education program is based on scientific research and publications on patient education from renowned organizations such as retrainpainorg and pain in motion and on extensive work previously done by members of the consortium The content will be standardized between the test centers UZA and Jessa
Phase 1 intervention at the hospital facility 24 sessions week 1-12 T0-T1 The three groups will follow a 12-week training program in which a time contingent approach is used as proposed by recent clinical practice guidelines To limit performance bias each group will train separately and will not be able to evaluate differences between the therapies
Group 1 TechnoHIT and group 2 HIT - These groups will perform 15h exercise therapy sessions twice a week comprising of a combination of cardiorespiratory interval general resistance and core muscle strength training all at high intensity according to a previously published protocol by our research group Briefly cardiorespiratory training consists of an interval protocol on a cycle ergo-meter consisting of five one-minute 100 VO2max workload bouts separated by one minute of active rest at 50 VO2max workload 100 VO2max bouts increase every two sessions by 10 Active rest remains stable This protocol is repeated from session 13 to 24 with an updated workload 5 WMax General resistance training consists of three upper body and three lower body exercises executed on fitness equipment performed at 80 of the one repetition maximum Core muscle strength training consists of six static core exercises and related progressions Exercises were chosen in function of their ability to load the core muscles at an intensity of 60 of the maximum voluntary contraction
Group 3 MIT control group - This group will perform 15h exercise therapy sessions twice a week of cardiorespiratory continuous load general resistance and core muscle training all at moderate intensity according to a previously published protocol by our research team Briefly cardiorespiratory training consists of a continuous training protocol on a cycle ergometer Participants start with 14 minutes of cycling 90 repetitions per minute at 60VO2max workload Duration will be increased every two sessions with 140 up to 2240 This protocol is repeated from session 13 to 24 with an updated workload 5 WMax General resistance training is identical to the protocol described in HIT with the exception of the exercise intensity exercises are performed here at 60 of 1RM Core muscle strength training is identical to the protocol described in HIT with the exception of the exercise intensity Participants perform one set of ten repetitions of a ten second static hold Exercises are made more difficult when they were executed with a stable core posture for the indicated time by increasing the time of the static hold each six sessions
Phase 2 intervention at home 24 sessions week 13-24 T1-T2 The three groups will follow a comparable 12-week training program as phase 1 but in their home setting The participants of group 1 will be supported by a mobile application on their phone The participants of group 1 2 will be provided with a fitness bike a smartwatch Polar M200 and training mat during the execution of this phase Sessions missed by the participants because of adverse events eg acute increase of low back pain acute musculoskeletal issues due to exercises will be registered
Group 1 TECHNO-HIT - Participants in this group receive an exercise schedule via the TechnoHIT mobile application a home trainer E50 Tunturi Fitness a heartrate sensor H10 Polara and smartwatch Ignite Polar and a training mat for the duration of this phase They are asked to perform a 60 min home program twice a week containing cardiorespiratory and core muscle strength training both at high intensity HIT protocol methods are equal to those in Phase 1 The training sessions of these patients are guided by the mobile application The user reports performes exercises in the mobile application that keeps track of their progress calculates compliance with the program and gives motivational feedback based on the patients performance and adherence
Group 2 HIT - Participants in this group receive an exercise schedule on paper a home trainer ie fitness bike and a training mat for the duration of this phase They are asked to perform a one-hour home program twice a week containing cardiorespiratory and core muscle strength training both at high intensity They also receive a diary to log their training sessions
Group 3 MIT control group - Participants in this group receive an exercise schedule on paper They are asked to perform a one-hour home program twice a week containing cardiorespiratory and core muscle training both at moderate intensity They also receive a diary to log their training sessions As we decided not to provide a bicycle and exercise mat in order to match the therapy as usual setting cardiorespiratory training in this phase will be based on a brisk walking modality performed at the same moderate exercise intensity and matched for training volume
The Techno-HIT home-training system consists of the following components and main functionalities
a mobile application for the patients at home to receive the HIT training program to schedule the training in sessions over the week to receive reminders and notifications to see the overall HIT training program or get more details on exercises and performed sessions to have access to exercise instructions to get guidance by the app while performing the exercises to get motivational feedback after performing the exercise and reporting the status to get feedback about progress and adherence to select a strategy to improve the adherence to report a variety of activities beyond the HIT program etc
a dashboard application for the physiotherapists researchers to see an overview of notifications about the patients training status to search through patient files and notifications to manage patient groups to provide the info on the HIT training to update exercise parameters to follow-up on the patients progress and view aggregated visual representations of progress to send hints to the patients to follow system suggestions for a progression or regression to give feedback to patients Some functionalities are admin functionalities and require an authorized account eg to create new patient files to manage caregiver accounts etc
Participants perform two assessments at baseline T-1 PRE before psychosocial education T0 PRE after psychosocial education and 4 longitudinal assessment T1 MID after a 12-week program in-hospital T2 POST after a 12-week program at home T3 POST 6 month follow-up T4 POST 18 month follow-up consisting of both physical testings and filling in health and disease related questionnaires At T-1 the assessments have a duration of approximately 2 hours 90min questionnaires 30min QST measurements During this assessment sociodemographic data of the participant will also be collected At T0 physical assessments will be added aswell as additional questionnaires T0 will have a duration of approximately 3 hours At T1 T2 T3 and T4 additional questionnaires will be added increasing the duration to 3 hours and 40 minutes
A rater cross-over assessment protocol will be used to ensure blinding of assessors All assessments are carried out by trained PhD-students and postdoctoral researchers that are part of the FWO Techno-HIT Trial project in the specialized movement and pain assessment labs of REVAL UHasselt and MOVANT UAntwerpen see section outcomes for detailed information on the depicted outcome measures
All data is treated confidentially and encrypted during the execution of the tests HIT-TECH followed by a timing letternumber T-1 A T00 T11 T22 T33 T44 and a sequence number 01 to 15 To associate the data with the subjects during data analysis a subject identification list 0-15 randomized is used The identification and key of the code is monitored by an independent researcher who is not involved in the research All data collected is stored in the Google Drive UHasseltMicrosoft Teams UAntwerp file stream and only members of the research team with a university account and password can access the source data Source data is kept for 25 years in accordance with GCP standards for reuse or for results validation
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