NCT06698055

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2023

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2025

Completed
Last Updated

December 16, 2025

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

May 29, 2023

Last Update Submit

December 8, 2025

Conditions

Keywords

Skeletal MuscleResistance ExerciseMagnetic Resonance ImagingEMGMuscle HypertrophyFlywheel TrainingStrength Training in Children and AdolescentsGrowth PlateMuscle AdaptationMuscle MemoryHistologyImmunohistochemistryTranscriptomicsMethylomicsProteomicsFunctional OutcomesPhysical Activity MonitoringPhysical Self Esteem

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 COMPARATOR

FW 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.

Other: Flywheel Resistance Exercise

aWS = Weight stack resistance exercise intervention group adults

ACTIVE COMPARATOR

WS 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.

Other: Weight Stack Resistance Exercise

aCON = Control group adults

NO INTERVENTION

The 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 COMPARATOR

FW 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.

Other: Flywheel Resistance Exercise

cWS = Weight stack resistance exercise intervention group children

ACTIVE COMPARATOR

WS 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.

Other: Weight Stack Resistance Exercise

cCON = Control group children

NO INTERVENTION

The 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).

aFW = Flywheel resistance exercise intervention group adultscFW = Flywheel resistance exercise intervention group children

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)

aWS = Weight stack resistance exercise intervention group adultscWS = Weight stack resistance exercise intervention group children

Eligibility Criteria

Age9 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Department of Orthopaedic Surgery, Höglandssjukhuset District Hospital Eksjö

Eksjö, Region Jönköping County, 57581, Sweden

Location

Study Officials

  • Björn A Alkner, MD, PhD

    Department of Orthopaedic Surgery, Eksjö, Region Jönköping County and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled resistance exercise intervention study
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

All data will be shared upon reasonable request when the data set is is complete

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Upon study completion
Access Criteria
Upon reasonable request

Locations