- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04849923
Validation of a Digital Twin Performing Strength Training
Validation of a Digital Twin to Predict the Adaptation of Muscle Strength and Muscle Size Due to Strength Training
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 (i.e. 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 strength training 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 1.3 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.
Study Overview
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 by means of the advanced computational modelling, biomechanical analysis and mobile monitoring technology. Of particular interest is the prediction of 1RM, sprint time, CMJ and SJ. 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.
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 function.
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 (n=36, with 18F and 18M). 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. Strength- and training-specific parameters include repetition count, mean concentric velocity, 1RM, 5m and 20 sprint time, counter movement and squat jump and 1 RM.
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 (i.e. primary outcome parameters: 1RM and H:Q ratio) following different training volumes of key muscle groups associated with knee joint stability. A power analysis was conducted using statistikguru.de to assess the required sample size for the primary outcome parameter, 1RM.
All participants have to confirm their voluntary participation with a written informed consent before being submitted to any study procedure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Canton of Zurich
-
Winterthur, Canton of Zurich, Switzerland, 8400
- Silvio Lorenzetti
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy participants; and
- Age 20-40 years old; and
- No acute or chronic musculoskeletal symptoms or pain; and
- Experience with strength training (at least 1-year strength training experience with one training session per week or more); and
- Familiar with strength exercises of key muscles associated with knee joint stability.
Exclusion Criteria:
- Acute or chronic musculoskeletal pain; and/or
- Musculoskeletal surgery within the last 12 months; and/or
- Ongoing rehabilitation or treatment of musculoskeletal complaints or injury; and/or
- Neuromusculoskeletal disease (e.g. cerebral palsy); and/or
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2 trainings per week
This group performs two strength training sessions per week
|
Conduct of an 6-week strength training intervention of key muscle-tendon groups associated with knee joint stability in the training-specific setting of each participant.
Participants are asked to record exercise load and volume as well as monitor training-related variables and 1RM using the iOS Strength Control app.
Participants perform the strength training self-directedly in their chosen fitness/training facilities as it fits into their weekly routine.
Contact to the study investigator is ensured at all times in case of questions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stop-and-go (SAG) Ability
Time Frame: 8 weeks
|
Change of the time for the stop and go task.
Calculation: Post time minus pre time.
|
8 weeks
|
|
20 m Sprint Performance
Time Frame: 8 weeks
|
Change of the Sprint time, s
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Jump Performance CMJ
Time Frame: 8 weeks
|
Change of Countermovement jump (CMJ) height
|
8 weeks
|
|
Changes in Jump Performance SJ
Time Frame: 8 weeks
|
Change of the jump hight squat jump (SJ)
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Silvio Lorenzetti, Prof. Dr., ZHAW School of Engineering
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Digital Twin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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