Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04849923
Status:
UNKNOWN
Last Update Posted:
2022-07-12
First Post:
2021-04-13
Brief Title:
Validation of a Digital Twin Performing Strength Training
Sponsor:
Swiss Federal Institute of Sport Magglingen
Organization:
Swiss Federal Institute of Sport Magglingen
Study Overview
Official Title:
Validation of a Digital Twin to Predict the Adaptation of Muscle Strength and Muscle Size Due to Strength Training
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Background Muscular strength training interventions have long been a cornerstone in the prevention non-surgical management and rehabilitation of the entire spectrum of musculoskeletal injuries and diseases The key goal of strength training especially during rehabilitation is to regain healthy musculoskeletal function Yet there remains a fundamental lack of understanding with regards to the relationship between subject-specific musculoskeletal biomechanics ie multi-body dynamics function and different types of strength training interventions because of limitations in assessing these parameters outside the research setting Thus clinicians physiotherapists and coaches continue making training recommendations based on subjective and generalised guidelines with ineffective or possibly harmful consequences for individual patients and athletes
Goal This project aims to advance strength training guidelines and monitoring of training safety and efficiency by means of subject-specific anatomically-based modelling biomechanical analysis of musculoskeletal function and mobile monitoring of training volume and muscular fatigue in the athletic and recreational setting
Method For validation purposes the investigators will conduct an 8-week intervention study in healthy volunteers with three levels of strength training volume of the key muscle-tendon groups associated with knee joint stability and relate the changes in musculoskeletal and biomechanical parameters to the training-specific parameters and muscular fatigue from mobile monitoring through correlation analysis
Relevance In Switzerland more than 13 Mio people are members of a fitness center Strength training is not only a cornerstone in the maintenance of fitness and rehabilitation from musculoskeletal injuries and diseases as the most frequently reported health issues
Goal This project aims to advance strength training guidelines and monitoring of training safety and efficiency by means of subject-specific anatomically-based modelling biomechanical analysis of musculoskeletal function and mobile monitoring of training volume and muscular fatigue in the athletic and recreational setting
Method For validation purposes the investigators will conduct an 8-week intervention study in healthy volunteers with three levels of strength training volume of the key muscle-tendon groups associated with knee joint stability and relate the changes in musculoskeletal and biomechanical parameters to the training-specific parameters and muscular fatigue from mobile monitoring through correlation analysis
Relevance In Switzerland more than 13 Mio people are members of a fitness center Strength training is not only a cornerstone in the maintenance of fitness and rehabilitation from musculoskeletal injuries and diseases as the most frequently reported health issues
Detailed Description:
Hypothesis It is hypothesized that advanced subject-specific musculoskeletal modelling in combination with mobile monitoring technology as embedded in the iPhone and Apple Watch allow for accurate prediction of changes in muscle strength and muscle size in the lower limbs following an 8-week strength training intervention of key muscle-tendon groups associated with knee joint stability
Primary Objective Prediction of changes in muscle strength in the lower limbs due to different strength training volumes by means of the advanced computational modelling biomechanical analysis and mobile monitoring technology Of particular interest is the prediction of 1RM and the prediction of the ratio between hamstrings and quadriceps strength HQ ratio compared against isokinetic strength tests as gold standard Research has clearly shown that the quantification of 1RM is fundamentally important when it comes to the design of safe and efficient resistance training programs
Secondary Objective Assessment of changes in muscle size in the lower limbs due to different strength training volumes using the HMF technique Of particular interest is the prediction of muscle volume using the HMF technique compared against data from MRI as gold standard as well as the prediction of adaptation in hamstrings and quadriceps CSA due to the strength training intervention using HMF versus data from ultrasound respectively
Key baseline factors that will likely influence the primary and secondary endpoints are strength training experience and gender The sample size and population group are specified to allow the analysis of gender-specific differences on study results Thereby the inclusionexclusion criteria and study protocol including a training-related questionnaire are defined to minimize the bias of training experience
Project design This project in sports science is designed as a confirmatory qualitative study in applied research involving healthy participants The rationale of this project is to predict changes in muscle strength and muscle size due to strength training using computational modelling and mobile monitoring technology In particular the investigators will advance novel approaches in subject-specific anatomically-based modelling and mobile monitoring which have previously tested in the research setting and are now being applied to an intervention study in healthy volunteers to predict adaptations in muscle strength and muscle size in relation to strength training volume
Study design The specifics of the strength training intervention are carefully designed based on the current state of research in the field and in line with strength training recommendations in musculoskeletal health fitness and rehabilitation In particular the investigators will conduct an 8-week strength training intervention program of the key muscle-tendon groups associated with knee joint stability hamstrings quadriceps and triceps surae with the study group n36 with 18F and 18M being randomly allocated to different levels of training volume Group1 no training Group2 1 training per week Group3 3 trainings per week with the same number of subjects and gender distribution in each group Each participant will perform the strength training self-directedly in their chosen training-specific setting Clear guidelines for warm-up type and conduct of exercises will be given to all participants The strength exercises are standard exercises for strengthening knee extension and flexion squats leg press back extensions heel raises and single joint exercises
Study parameters Anthropometric parameters include body height body weight segmental circumferences somatotype body shape muscle CSA and muscle volume of the lower limbs Anthropometric parameters will be assessed by means of HMF fitting in combination with data from 3D body scanning and anthropometric measurements according to ISAK standards Changes in CSA of the hamstrings and quadriceps will be compared between HMF and data from ultrasound before and after strength training intervention Strength- and training-specific parameters include joint motion joint acceleration total joint moments repetition count 1RM and HQ ratio Strength- and training-specific parameters will be assessed by means of biomechanical analysis using data from optical motion capture and the iOS Strength Control app and compared against data from isokinetic strength tests as gold standard Additionally data from MRI of the lower limbs will be acquired in a sub-group of 12 participants 6F 6M
PROJECT POPULATION AND STUDY PROCEDURES
Project population The project population are healthy adult subjects who are all participating in their own strength training program on a regular weekly basis The primary objective is to predict changes in muscle strength ie primary outcome parameters 1RM and HQ ratio following different training volumes of key muscle groups associated with knee joint stability A power analysis was conducted using statistikgurude to assess the required sample size for the primary outcome parameter 1RM Based on the power analysis the investigators aim for a total of n36 complete data sets n12 per study group of the strength training intervention with a sub-group of n12 participants additionally scheduled for MRI of the lower limbs at baseline
The MRI-based assessment of muscle volume for validation of the HMF technique is analyzed independently from the strength training intervention Thereby the accuracy of the HMF technique is dependent on the initial generic musculoskeletal model that is used for model fitting as well as the available subject-specific skin surface and anthropometric data
All participants have to confirm their voluntary participation with a written informed consent before being submitted to any study procedure
Primary Objective Prediction of changes in muscle strength in the lower limbs due to different strength training volumes by means of the advanced computational modelling biomechanical analysis and mobile monitoring technology Of particular interest is the prediction of 1RM and the prediction of the ratio between hamstrings and quadriceps strength HQ ratio compared against isokinetic strength tests as gold standard Research has clearly shown that the quantification of 1RM is fundamentally important when it comes to the design of safe and efficient resistance training programs
Secondary Objective Assessment of changes in muscle size in the lower limbs due to different strength training volumes using the HMF technique Of particular interest is the prediction of muscle volume using the HMF technique compared against data from MRI as gold standard as well as the prediction of adaptation in hamstrings and quadriceps CSA due to the strength training intervention using HMF versus data from ultrasound respectively
Key baseline factors that will likely influence the primary and secondary endpoints are strength training experience and gender The sample size and population group are specified to allow the analysis of gender-specific differences on study results Thereby the inclusionexclusion criteria and study protocol including a training-related questionnaire are defined to minimize the bias of training experience
Project design This project in sports science is designed as a confirmatory qualitative study in applied research involving healthy participants The rationale of this project is to predict changes in muscle strength and muscle size due to strength training using computational modelling and mobile monitoring technology In particular the investigators will advance novel approaches in subject-specific anatomically-based modelling and mobile monitoring which have previously tested in the research setting and are now being applied to an intervention study in healthy volunteers to predict adaptations in muscle strength and muscle size in relation to strength training volume
Study design The specifics of the strength training intervention are carefully designed based on the current state of research in the field and in line with strength training recommendations in musculoskeletal health fitness and rehabilitation In particular the investigators will conduct an 8-week strength training intervention program of the key muscle-tendon groups associated with knee joint stability hamstrings quadriceps and triceps surae with the study group n36 with 18F and 18M being randomly allocated to different levels of training volume Group1 no training Group2 1 training per week Group3 3 trainings per week with the same number of subjects and gender distribution in each group Each participant will perform the strength training self-directedly in their chosen training-specific setting Clear guidelines for warm-up type and conduct of exercises will be given to all participants The strength exercises are standard exercises for strengthening knee extension and flexion squats leg press back extensions heel raises and single joint exercises
Study parameters Anthropometric parameters include body height body weight segmental circumferences somatotype body shape muscle CSA and muscle volume of the lower limbs Anthropometric parameters will be assessed by means of HMF fitting in combination with data from 3D body scanning and anthropometric measurements according to ISAK standards Changes in CSA of the hamstrings and quadriceps will be compared between HMF and data from ultrasound before and after strength training intervention Strength- and training-specific parameters include joint motion joint acceleration total joint moments repetition count 1RM and HQ ratio Strength- and training-specific parameters will be assessed by means of biomechanical analysis using data from optical motion capture and the iOS Strength Control app and compared against data from isokinetic strength tests as gold standard Additionally data from MRI of the lower limbs will be acquired in a sub-group of 12 participants 6F 6M
PROJECT POPULATION AND STUDY PROCEDURES
Project population The project population are healthy adult subjects who are all participating in their own strength training program on a regular weekly basis The primary objective is to predict changes in muscle strength ie primary outcome parameters 1RM and HQ ratio following different training volumes of key muscle groups associated with knee joint stability A power analysis was conducted using statistikgurude to assess the required sample size for the primary outcome parameter 1RM Based on the power analysis the investigators aim for a total of n36 complete data sets n12 per study group of the strength training intervention with a sub-group of n12 participants additionally scheduled for MRI of the lower limbs at baseline
The MRI-based assessment of muscle volume for validation of the HMF technique is analyzed independently from the strength training intervention Thereby the accuracy of the HMF technique is dependent on the initial generic musculoskeletal model that is used for model fitting as well as the available subject-specific skin surface and anthropometric data
All participants have to confirm their voluntary participation with a written informed consent before being submitted to any study procedure
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