NCT06573086

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 individual's sensitivity to respond to RT. Moreover, investigators aim to assess whether a responsiveness to RT predicts responsiveness to endurance training (ET). Thus, investigators aim to gain a deeper understanding of exercise 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?
  • Are the high, moderate, and low responders of RT also the highest, moderate, and lowest responders to ET? To examine these main research questions, high (n=30), low (n=30), and moderate (n=30) responders of skeletal muscle growth in response to RT (intervention I, NCT05874986) are reallocated into a subsequent 12-week RT intervention (intervention II) after a detraining period. A subgroup of these participants (n=10) will engage in a 6-week control period before starting the second RT period. Additionally, after intervention II, participants will participate in an ET intervention, lasting 6 weeks. 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 acute 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
  • Providing saliva samples (30-32 in total) for the assessment of body water enrichment of deuterium
  • Providing a muscle biopsy four or five (4-5) times during the study
  • Providing a blood sample fourteen (14) times during the study
  • Assessed for body composition and body volume four or five times (4-5) during the study
  • Participating in muscle size, maximal dynamic strength and TMS measurements four or five (4-5) times during the study
  • Asked to answer questionnaires related to e.g. stress, physical activity, sleep, perceived exertion, and diet
  • Participating in recovery measurements before and after the second-to-last and the last RT bout, and once in the days between these RT bouts, consisting of six (6) body volume measurements and six (6) maximal voluntary isometric contraction (kg) tests using horizontal leg press for the assessment of neuromuscular recovery
  • Participating in an acute resistance exercise (RE) after the 12-week RT intervention. Furthermore, in the ET intervention, participants will be:
  • Participating in a familiarization session and resting electrocardiograph measurements before the intervention
  • Participating in endurance testing consisting of body composition, movement economy, and incremental RAMP testing before and after ET intervention
  • Endurance training with supervision for 6 weeks, three times a week.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 29, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

July 29, 2024

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in m. vastus lateralis (VL) cross-sectional area (CSA) with ultrasound (US)

    VL CSA (cm\^2) is determined at mid-thigh using a B-mode axial plane US (Venue Fit R4, GE Medical Systems, USA) with a L4-20t-RS linear-array probe (48,43 mm width) in extended-field-of-view mode (6/12 MHz, 39 frames per second). Additionally, VL CSA (cm\^2) will also be determined at baseline with different US, at mid-thigh using a B-mode axial plane US (model SSD-α10, Aloka, Tokyo, Japan) with a 13 MHz linear-array probe (60 mm width) in extended-field-of-view mode (23 Hz sampling frequency). Aloka-US was used in the intervention I, but GE-US in intervention II due to the progressive malfunctioning of Aloka. Therefore, both machines are used in baseline measurements to calculate the plausible inter-US variability. The CSA will be measured using the polygon function in ImageJ software. Per each measurement, three images will be analysed from which the average from the two closest ones will be calculated.

    Baseline (test and retest), week 7, week 13

Secondary Outcomes (47)

  • Muscle protein synthesis (MPS) with the Combined Oral Stable Isotope Assessment of Muscle (COSIAM)

    From baseline to week 7 (6 weeks of RT in duration)

  • Muscle protein breakdown (MPB) with the Combined Oral Stable Isotope Assessment of Muscle (COSIAM)

    Baseline, Week 7

  • Change in whole-body skeletal muscle mass (SMM) with the Combined Oral Stable Isotope Assessment of Muscle (COSIAM)

    Baseline, Week 7

  • Change in muscle thickness (MT) of the elbow flexors after 6 and 12-week resistance training

    Baseline (test and retest), week 7, week 13

  • Change in lower and upper limb maximal strength after 6 and 12-week resistance training

    Baseline (test and retest), week 7, week 13,

  • +42 more secondary outcomes

Study Arms (3)

High responders (n=30)

EXPERIMENTAL

This group consists of participants with the highest increase in skeletal muscle hypertrophy of m. vastus lateralis in response to the initial 12 weeks of RT (Intervention I).

Other: Resistance Training

Moderate responders (n=30)

EXPERIMENTAL

This group consists of participants with the moderate increase in skeletal muscle hypertrophy of m. vastus lateralis in response to the initial 12 weeks of RT (Intervention I).

Other: Resistance Training

Low Responders (n=30)

EXPERIMENTAL

This group consists of participants with the lowest increase in skeletal muscle hypertrophy of m. vastus lateralis in response to the initial 12 weeks of RT (Intervention I).

Other: Resistance Training

Interventions

12-week resistance training

Also known as: Exercise Training
High responders (n=30)Low Responders (n=30)Moderate responders (n=30)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-50
  • healthy (e.g., no diagnosed type 2 diabetes, cardiovascular disease, musculoskeletal disorders, etc.)
  • prior participation in intervention I (NCT05874986)

You may not qualify if:

  • medication affecting the cardiovascular system or metabolism
  • metabolic, musculoskeletal, cardiovascular, or other diseases or disorders which may preclude the ability to perform exercise training and testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jyväskylä

Jyväskylä, Central Finland, 40014, Finland

RECRUITING

MeSH Terms

Conditions

HypertrophyMuscular Atrophy

Interventions

Resistance TrainingExercise

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophySigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Juha P Ahtiainen, Assoc.Prof.

    University of Jyväskylä, Faculty of Sport and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juha P Ahtiainen, Assoc.Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 27, 2024

Study Start

August 19, 2024

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following publication. No end date.
Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to juha.ahtiainen@jyu.fi

Locations