Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573086
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Resistance Training Detraining and Retraining Study 2024 TraDeRe2024
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Towards Personalized Exercise Identifying the Determinants of Individual Variation in Resistance Training Detraining and Retraining TraDeRe
Status:
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:
TraDeRe
Brief Summary:
The goals of our research project are to identify factors explaining inter-individual variation in responses to resistance training RT and the baseline determinants underlying an individuals sensitivity to respond to RT Thus investigators aim to gain a deeper understanding of RT adaptation processes The main questions investigators aim to answer are
Can the physiological responses of one RT intervention be extrapolated to a subsequent RT intervention
If so what are the mechanisms underlying differing skeletal muscle growth responses in low and high responders of skeletal muscle hypertrophy
If so do the low responders of skeletal muscle growth respond more favourably when the amount of RT is increased
To examine these main research questions high n30 low n30 and moderate n30 responders of skeletal muscle growth in response to RT intervention I NCT05874986 are reallocated into a subsequent RT intervention intervention II after a detraining period
In this intervention II reallocated participants will be
Resistance training with supervision for 12 weeks
Consuming deuterium oxide for the assessment of muscle protein synthesis
Consuming D3-3-methylhistidine for the assessment of muscle protein breakdown
Consuming D3-creatine for the examination of whole-body skeletal muscle mass
Providing a spot urine sample six 6 times and urine collection for 24 hours performed twice after each drink
Providing a saliva sample two 2 times per week before and after drinking D2O for a duration of 6 weeks and additionally 24 and 48 hours after the first 3 boluses
Providing a muscle biopsy four 4 times during the study
Providing a blood sample fourteen 14 times during the study
Assessed for body composition and body volume four times 4 during the study
Participating in muscle size and strength measurements ten 10 times during the study of which four 4 include neuromuscular measurements
Asked to answer questionnaires related to eg stress physical activity sleep and diet
Participating in an acute resistance exercise RE and associated recovery assessments for the next five consecutive days following RE
Can the physiological responses of one RT intervention be extrapolated to a subsequent RT intervention
If so what are the mechanisms underlying differing skeletal muscle growth responses in low and high responders of skeletal muscle hypertrophy
If so do the low responders of skeletal muscle growth respond more favourably when the amount of RT is increased
To examine these main research questions high n30 low n30 and moderate n30 responders of skeletal muscle growth in response to RT intervention I NCT05874986 are reallocated into a subsequent RT intervention intervention II after a detraining period
In this intervention II reallocated participants will be
Resistance training with supervision for 12 weeks
Consuming deuterium oxide for the assessment of muscle protein synthesis
Consuming D3-3-methylhistidine for the assessment of muscle protein breakdown
Consuming D3-creatine for the examination of whole-body skeletal muscle mass
Providing a spot urine sample six 6 times and urine collection for 24 hours performed twice after each drink
Providing a saliva sample two 2 times per week before and after drinking D2O for a duration of 6 weeks and additionally 24 and 48 hours after the first 3 boluses
Providing a muscle biopsy four 4 times during the study
Providing a blood sample fourteen 14 times during the study
Assessed for body composition and body volume four times 4 during the study
Participating in muscle size and strength measurements ten 10 times during the study of which four 4 include neuromuscular measurements
Asked to answer questionnaires related to eg stress physical activity sleep and diet
Participating in an acute resistance exercise RE and associated recovery assessments for the next five consecutive days following RE
Detailed Description:
While the diverse health and performance benefits of resistance training RT are widely recognized some individuals demonstrate notably divergent responses to RT intervention This phenomenon is termed inter-individual response variation to RT However despite the prevalence of these research findings the precise underlying mechanisms contributing to these differential RT responses remain ambiguous
Investigators aim to investigate the cellular molecular and neuromuscular mechanisms behind the plausible RT response variability intra- and inter-individually using trial-to-trial ie resistance training detraining and retraining -design Moreover as the impact of diverse polygenic effects on RT responsiveness is yet to be determined investigators will employ a multi-OMIC genomic epigenomic transcriptomic proteomic and metabolomic approach to unravel previously unknown denominators of RT responsiveness Finally numerous environmental factors eg nutrition stress sleep and physical activity are monitored during the study to assess the effects of non-physiological mechanisms on RT response variability
In our study healthy male and female participants n 400 were initially recruited and underwent an RT period of 12 weeks in two separate periods intervention I refers to NCT05874986 Then a subset of the participants from intervention I will be reallocated into intervention II based on the magnitude increase of m vastus lateralis VL cross-sectional area CSA assessed by ultrasound using extended-field-of-view -mode Similar to intervention I intervention II will be performed in separate periods similarly to the data collection I and II of intervention I to first accumulate approximately 32 weeks of detraining for both cohorts after which 12 weeks of RT is performed
Moreover a subset n30 of the participants aged 40-50 from intervention I not selected for intervention II have a chance to take part in a 10-week home training sub-study These participants will be randomized to a non-training control group n15 and a home training group n15 The home training group will carry out a 10-week RT period utilizing muscle-strengthening activities in their home This sub-study investigates how minimally supervised RT executed at home after supervised gym RT can maintain muscle strength and size compared to non-training Home training is flexible time-saving and inexpensive It is also done twice weekly using safe and effective training protocols and movements Home-based training includes pistol squat reverse nordic push up and bent-over row and bicep curl exercises To achieve progression the total load will be increased by increasing the number of repetitions per set andor increasing the load by using a progression from easier to more difficult techniques andor by adding resistance bands which will be provided to participants free of charge for the duration of the study Participants will be contacted regularly to ensure motivation and adherence to home exercise All the participants in this sub-study as well as the other participants not selected for intervention II are offered a self-directed non-supervised 7-week RT period with a similar design as in intervention I with access to our gym located in our Facultys building VL CSA horizontal leg press 1 repetition maximum and body composition will be assessed before and after home training and self-directed RT for each participant
In intervention II participants will be performing RT similarly as in intervention I However for the last 5-weeks of the intervention RT volume will be increased by 40 for the lower body exercises to assess the impact of RT volume increment on RT responses After 12 weeks of RT an experimental RT session will be conducted to assess the acute physiological responses to resistance exercise The experimental session will consist of five heavy sets of both horizontal leg press and leg extension exercises After the experimental session recovery will be monitored for the next five days
In this study investigators aim to identify several previously unknown molecular determinants that underlie the observed heterogeneity in RT responses This could significantly increase the understanding of exercise physiology which can be applied eg in sports medicine rehabilitation and sports coaching Moreover this study can promote the development of personalized RT prescriptions as part of health care Finally the findings of the study can operate as a foundational work for future research on the topic of RT response heterogeneity
Investigators aim to investigate the cellular molecular and neuromuscular mechanisms behind the plausible RT response variability intra- and inter-individually using trial-to-trial ie resistance training detraining and retraining -design Moreover as the impact of diverse polygenic effects on RT responsiveness is yet to be determined investigators will employ a multi-OMIC genomic epigenomic transcriptomic proteomic and metabolomic approach to unravel previously unknown denominators of RT responsiveness Finally numerous environmental factors eg nutrition stress sleep and physical activity are monitored during the study to assess the effects of non-physiological mechanisms on RT response variability
In our study healthy male and female participants n 400 were initially recruited and underwent an RT period of 12 weeks in two separate periods intervention I refers to NCT05874986 Then a subset of the participants from intervention I will be reallocated into intervention II based on the magnitude increase of m vastus lateralis VL cross-sectional area CSA assessed by ultrasound using extended-field-of-view -mode Similar to intervention I intervention II will be performed in separate periods similarly to the data collection I and II of intervention I to first accumulate approximately 32 weeks of detraining for both cohorts after which 12 weeks of RT is performed
Moreover a subset n30 of the participants aged 40-50 from intervention I not selected for intervention II have a chance to take part in a 10-week home training sub-study These participants will be randomized to a non-training control group n15 and a home training group n15 The home training group will carry out a 10-week RT period utilizing muscle-strengthening activities in their home This sub-study investigates how minimally supervised RT executed at home after supervised gym RT can maintain muscle strength and size compared to non-training Home training is flexible time-saving and inexpensive It is also done twice weekly using safe and effective training protocols and movements Home-based training includes pistol squat reverse nordic push up and bent-over row and bicep curl exercises To achieve progression the total load will be increased by increasing the number of repetitions per set andor increasing the load by using a progression from easier to more difficult techniques andor by adding resistance bands which will be provided to participants free of charge for the duration of the study Participants will be contacted regularly to ensure motivation and adherence to home exercise All the participants in this sub-study as well as the other participants not selected for intervention II are offered a self-directed non-supervised 7-week RT period with a similar design as in intervention I with access to our gym located in our Facultys building VL CSA horizontal leg press 1 repetition maximum and body composition will be assessed before and after home training and self-directed RT for each participant
In intervention II participants will be performing RT similarly as in intervention I However for the last 5-weeks of the intervention RT volume will be increased by 40 for the lower body exercises to assess the impact of RT volume increment on RT responses After 12 weeks of RT an experimental RT session will be conducted to assess the acute physiological responses to resistance exercise The experimental session will consist of five heavy sets of both horizontal leg press and leg extension exercises After the experimental session recovery will be monitored for the next five days
In this study investigators aim to identify several previously unknown molecular determinants that underlie the observed heterogeneity in RT responses This could significantly increase the understanding of exercise physiology which can be applied eg in sports medicine rehabilitation and sports coaching Moreover this study can promote the development of personalized RT prescriptions as part of health care Finally the findings of the study can operate as a foundational work for future research on the topic of RT response heterogeneity
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