Muscle Adaptations in Children and Adults Following Twelve Weeks of Flywheel or Weight Stack Resistance Exercise
KidREx
KidREx - Muscle Adaptations in Children and Adults Following a Twelve-week of Resistance Exercise Period Using Either Flywheel or Traditional Weight Stack Devices - a Randomized Controlled Study
1 other identifier
interventional
91
1 country
1
Brief Summary
The goal of this trial is to compare resistance exercise using traditional techniques and flywheel training to controls in healthy children ages nine to 13 and adults ages 18 to 50. The main questions it aims to answer are:
- The degree of response to resistance exercise in children compared to adults regarding muscle hypertrophy and strength?
- Is there a negative impact on the physis of children due to resistance exercise? Participants will be randomized to one of three groups, control, traditional resistance exercise, or flywheel. Following a baseline battery of tests, they will enter a 12-week training period, using leg press and leg extension. Additionally, post-training tests are conducted, and an eight-week detraining period commences followed by new tests. Researchers will compare children and adults and each intervention arm to see if children can achieve muscle hypertrophy, the degree and rate of changes in strength, and the potential impact on the physis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2022
CompletedFirst Submitted
Initial submission to the registry
May 29, 2023
CompletedFirst Posted
Study publicly available on registry
November 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2025
CompletedDecember 16, 2025
April 1, 2025
2.4 years
May 29, 2023
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Muscle Volume Following 12 Weeks of Resistance Exercies
The groups of children and adults will undergo magnetic resonance imaging of the anterior thigh in a standardized fashion. Subsequently, the muscle volume is calculated by contouring cross-sectional area of muscle. Primary analysis is muscle growth of the m. quadriceps femoris in the two active comparator groups compared to the control group.
Time Frame: Before intervention start (0 weeks) and following twelve weeks of training (12 weeks)
Secondary Outcomes (22)
Changes in muscle thickness
Time Frame: Prior to intervention start, biweekly during the intervention period (i.e., after two, four, six and eight weeks). Additional scans will be performed following the end of intervention (12 weeks) and the end of detraining (20 weeks).
Change from baseline in rate of physeal closure following resistance exercise
Time Frame: Baseline (0 weeks), post training (12 weeks) and post detraining (20 weeks)
Change in muscle volume at 20 weeks
Time Frame: Before intervention start (0 weeks) and end of intervention (12 weeks) compared to volume following the detraining period (20 weeks)]
Changes in peak torque during isokinetic concentric and eccentric knee extension and flexion
Time Frame: Baseline (0 weeks), post training (12 weeks) and post detraining (20 weeks)
Changes in power during isokinetic concentric and eccentric knee extension and flexion
Time Frame: Baseline (0 weeks), post training (12 weeks) and post detraining (20 weeks)
- +17 more secondary outcomes
Other Outcomes (6)
Activity level (adults)
Time Frame: Starting one week prior to intervention start and ending one week after detraining time point, a total of 22 weeks.
Monitoring of physical activity level (children)
All monitors will be worn for one week at three-time points (baseline, 12 weeks, 20 weeks) during the intervention
Questionnaire based assessment of physical activity (children)
Baseline (0 weeks), post training (12 weeks) and post detraining (20 weeks)
- +3 more other outcomes
Study Arms (6)
aFW = Flywheel resistance exercise intervention group adults
ACTIVE COMPARATORFW undergo a twelve-week training intervention with alternating two to three sessions per week. At each training session the participant will perform four sets of leg press and a leg extension with seven repetitions per set in each machine were resistance is provided by a flywheel and a weight stack respectively.
aWS = Weight stack resistance exercise intervention group adults
ACTIVE COMPARATORWS undergo a twelve-week training intervention with alternating two to three sessions per week. At each training session the participant will perform four sets of leg press and a leg extension with seven repetitions per set in each machine were resistance is provided by a flywheel and a weight stack respectively.
aCON = Control group adults
NO INTERVENTIONThe CON group will continue living as normally with the aim of remaining at a constant activity level like that at baseline. All groups undergo a baseline test battery witch is repeated following the end of the training period. After the training period all groups enter in to a detraining period were no weight training of the lower limb will be conducted for eight weeks. Following the detraining period the test battery will once more be repeated.
cFW = Flywheel resistance exercise intervention group children
ACTIVE COMPARATORFW undergo a twelve-week training intervention with alternating two to three sessions per week. At each training session the participant will perform four sets of leg press and a leg extension with seven repetitions per set in each machine were resistance is provided by a flywheel and a weight stack respectively.
cWS = Weight stack resistance exercise intervention group children
ACTIVE COMPARATORWS undergo a twelve-week training intervention with alternating two to three sessions per week. At each training session the participant will perform four sets of leg press and a leg extension with seven repetitions per set in each machine were resistance is provided by a flywheel and a weight stack respectively.
cCON = Control group children
NO INTERVENTIONThe CON group will continue living as normally with the aim of remaining at a constant activity level like that at baseline. All groups undergo a baseline test battery witch is repeated following the end of the training period. After the training period all groups enter in to a detraining period were no weight training of the lower limb will be conducted for eight weeks. Following the detraining period the test battery will once more be repeated.
Interventions
FW is conducted in a leg extension machine (LegExx, Exxentric, Stockholm, Sweden) and leg press machine (YoYo™ Leg Press, nHANCE, Sweden).
WS is conducted in a leg extension machine (Seated leg press, Nordic Gym, Bollnäs, Sweden) and a leg press machine (Seated leg extension, Nordic Gym, Bollnäs, Sweden)
Eligibility Criteria
You may not qualify if:
- Neuromuscular disease.
- Previous or current musculoskeletal injury, primarily of the lower limb, preventing resistance exercise.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Björn Alknerlead
- Karolinska Institutetcollaborator
- Umeå Universitycollaborator
- Medical Research Council of Southeast Swedencollaborator
- Swedish Research Council for Sport Sciencecollaborator
- Linkoeping Universitycollaborator
- The Swedish Research Councilcollaborator
Study Sites (1)
Department of Orthopaedic Surgery, Höglandssjukhuset District Hospital Eksjö
Eksjö, Region Jönköping County, 57581, Sweden
Study Officials
- PRINCIPAL INVESTIGATOR
Björn A Alkner, MD, PhD
Department of Orthopaedic Surgery, Eksjö, Region Jönköping County and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, MD, PhD, Associate professor
Study Record Dates
First Submitted
May 29, 2023
First Posted
November 20, 2024
Study Start
August 28, 2022
Primary Completion
February 2, 2025
Study Completion
February 12, 2025
Last Updated
December 16, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Upon study completion
- Access Criteria
- Upon reasonable request
All data will be shared upon reasonable request when the data set is is complete