NCT05874986

Brief Summary

It is well known that regular resistance training (RT) can have health benefits. However, considerable heterogeneity in RT responses has been observed. The mechanisms underlying an individual's ability to respond to RT are mainly unknown but involve a complex network of genomic and non-genomic factors. The investigators aim to examine heterogeneity in physiological responses to RT while closely monitoring other environmental factors (e.g., physical activity levels, nutrition, sleep, and stress). Participants are healthy sedentary males and females aged 18-50 (n=400). A controlled 12-week RT intervention will be conducted in two separate data collection periods due to our sample size to characterize RT response. Data will be collected before, during, and after the study period by using measurements of muscle size, physical fitness characteristics, and body composition, as well as by collecting blood samples and questionnaires. The investigators will identify the underlying factors contributing to why people differ in their physiological responses to RT. For this, comprehensive background data will be collected to identify common denominators underlying individual differences in response to RT. The investigators will use sophisticated analytical methods to reveal new predictors of training response for different traits. This research project aims to gain insight into the sources of individual variation in physiological responses to RT. On this basis, exercise training can be personalized to optimize the benefits of RT for all individuals. Ultimately, the investigators will also be able to justify better using RT as part of individualized healthcare strategies in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
393

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2024

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

February 23, 2023

Last Update Submit

April 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in m. vastus lateralis (VL) cross-sectional area (CSA) after 6 and 12-week resistance training

    VL CSA (cm\^2) is determined at mid-thigh using a B-mode axial plane ultrasound (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). However, since Aloka US began to show signs of malfunctioning before the onset of data collection II (approximately four months after the end of data collection I), another US device (Venue Fit R4, GE Medical Systems, USA) was used in data collection II. Due to this US-device change, test-retest measurements at baseline were performed with both devices in data collection II to enable statistical comparison of these devices later. GE-US was used 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).

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

Secondary Outcomes (16)

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

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

  • Change in whole-body volume (cm^3) after 6 and 12-weeks of resistance training

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

  • Change in whole body fat-free mass after 6 and 12-week resistance training

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

  • Change in whole body fat mass after 6 and 12-week resistance training

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

  • Change in waist circumference after 6 and 12-week resistance training

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

  • +11 more secondary outcomes

Other Outcomes (1)

  • Background information of the participants

    Baseline

Study Arms (2)

Training group (n=362)

OTHER

All the participants from data collection I and data collection II.

Other: Resistance training

Control group (n=75)

OTHER

The control group consists of the participants from the training group who undergo a control period before the intervention.

Other: Resistance training

Interventions

12-week resistance training intervention

Also known as: Exercise training
Control group (n=75)Training group (n=362)

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.)
  • limited experience in resistance training

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

Location

MeSH Terms

Interventions

Resistance TrainingExercise

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 23, 2023

First Posted

May 25, 2023

Study Start

February 22, 2023

Primary Completion

August 21, 2024

Study Completion

August 21, 2024

Last Updated

April 16, 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