RELIEF - Resistance Training for Life (RELIEF)

August 27, 2024 updated by: Stian Ellefsen

Resistance Training for Life - the Efficacy of Increasing Resistance Training Volume for Improving Muscle Mass, Function, Biology and Health in Young and Elderly

Sarcopenia is an age-related gradual loss of muscle mass and strength and is associated with physical disability and mortality risk. Currently, the most promising remedy for preventing and treating sarcopenia is physical activity, particularly progressive resistance training. Yet, the amount of resistance exercise needed to achieve optimal benefits remains largely unknown. This lack of knowledge is underpinned by the notion that aging reduces the ability to adapt to (and benefit from) resistance training, and is further complicated by a relative large degrees of between-subject heterogeneity. The primary aim of the study is to compare the effects of 10 weeks of resistance training with low- and moderate volume (one vs. three sets per exercise) on muscle mass accretion in lower and upper body extremities in young (<30 years of age) and elderly individuals (>70 years of age). Specifically, the study addresses the hypothesis that elderly individuals will benefit more from higher exercise volume (moderate vs. low) compared to their young counterparts. In addition, the study aims to compare the efficacy of the two volume conditions for altering other characteristics such as muscle strength and biology, including assessment of associations between individual changes in muscle mass, strength and biology (e.g. the relationship between muscle mass accretion and muscle content of rRNA/rDNA), and also to investigate the general health effects of the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Lillehammer, Norway, 2624
        • Inland Norway University of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages between 18 and 30 or > 70

Exclusion Criteria:

  • Resistance training, > 1 session per week
  • Endurance training, > 3 sessions per week
  • Unstable cardiovascular disease
  • Illness or serious injury contradicting resistance training
  • Serious mental illness
  • Allergy to local anaesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Resistance training group
Participants in two age groups will receive moderate (three sets of per exercise per session) and low-volume (one set of resistance per session) training allocated to either right or left upper- and lower extremities. A total of 24 sessions will be performed over 10-12 weeks.
Other: Progressive resistance training
Progressive resistance training, performed with a target number of repetitions of 10 per set. Sets are performed to exhaustion, and external load will be adjusted to meet the target number of repetitions.
No Intervention: Negative control group
A negative control group is included in the study which will not receive any resistance training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle size, lower extremities
Time Frame: Change from baseline to after the training period (10-12 weeks)
Muscle size of lower extremity knee extensors measured with magnetic resonance imaging (MRI).
Change from baseline to after the training period (10-12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle size, upper-body extremities
Time Frame: Change from baseline to after the training period (10-12 weeks)
Muscle size of upper extremity elbow flexors measured with magnetic resonance imaging (MRI).
Change from baseline to after the training period (10-12 weeks)
Appendicular lean mass, lower-body extremities
Time Frame: Change from baseline to after the training period (10-12 weeks)
Appendicular lean mass of the legs measured using Dual X-Ray Absorptiometry
Change from baseline to after the training period (10-12 weeks)
Appendicular lean mass, upper-body extremities
Time Frame: Change from baseline to after the training period (10-12 weeks)
Appendicular lean mass of the arms measured using Dual X-Ray Absorptiometry
Change from baseline to after the training period (10-12 weeks)
Muscle thickness, m. vastus lateralis
Time Frame: Change from baseline to after the training period (10-12 weeks)
Musle thickness of m. vastus lateralis measured using ultrasound
Change from baseline to after the training period (10-12 weeks)
Muscle strength, lower-body extremities
Time Frame: Change from baseline to after the training period (10-12 weeks)
Muscle strength of the legs measured as a weighted average of lower body isokinetic and isometric knee extensor maximal force
Change from baseline to after the training period (10-12 weeks)
Muscle strength, upper-body extremities
Time Frame: Change from baseline to after the training period (10-12 weeks)
Muscle strength of the arms measured as isometric force (elbow flexors; fixed angle)
Change from baseline to after the training period (10-12 weeks)
Muscular peak power/force, lower-body extremities
Time Frame: MeasurChange from baseline to after the training period (10-12 weeks)
Muscular peak power/force measured using dynamic leg press
MeasurChange from baseline to after the training period (10-12 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle thickness, m. vastus lateralis (mid)
Time Frame: Change from baseline to after 12 sessions
Musle thickness of m. vastus lateralis measured using ultrasound
Change from baseline to after 12 sessions
Muscle strength, lower-body extremities (mid)
Time Frame: Change from baseline to after 12 sessions
Muscle strength will be assessed as a weighted average of lower body isokinetic and isometric knee extensor maximal force
Change from baseline to after 12 sessions
Muscle strength, upper-body extremities (mid)
Time Frame: Change from baseline to after 12 sessions
Muscle strength of the arms measured as isometric force (elbow flexors; fixed angle)
Change from baseline to after 12 sessions
Muscular peak power/force, lower-body extremities
Time Frame: Change from baseline to after 12 sessions
Muscular peak power/force measured using dynamic leg press
Change from baseline to after 12 sessions
Muscle architecture, m. vastus lateralis (mid)
Time Frame: Change from baseline to after 12 sessions
Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound
Change from baseline to after 12 sessions
Muscle architecture, m. vastus lateralis
Time Frame: Change from baseline to the training period (10-12 weeks).
Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound
Change from baseline to the training period (10-12 weeks).
Body composition
Time Frame: Change from baseline to after the training period (10-12 weeks).
Whole Body Dual X-Ray Absorptiometry to estimate lean mass, bone mineral density and fat mass.
Change from baseline to after the training period (10-12 weeks).
Muscle fibre characteristics in m. vastus lateralis
Time Frame: Change from baseline to after the training period (10-12 weeks)
Muscle fiber characteristics such as muscle fiber proportions, cross-sectional area, myonuclei content and capillarization measured in biopsies from m. vastus lateralis
Change from baseline to after the training period (10-12 weeks)
Total-RNA abundance in m. vastus lateralis
Time Frame: Change from baseline to after the training period (10-12 weeks)
Total-RNA abundance measured in biopsies from m. vastus lateralis.
Change from baseline to after the training period (10-12 weeks)
Total-RNA abundance in m. vastus lateralis
Time Frame: Change from baseline to after 6 training sessions
Total-RNA abundance measured in biopsies from m. vastus lateralis.
Change from baseline to after 6 training sessions
rRNA/RNA abundances in m. vastus lateralis
Time Frame: Change from baseline to after the training period (10-12 weeks)
rRNA/RNA abundances measured in biopsies from m. vastus lateralis.
Change from baseline to after the training period (10-12 weeks)
rRNA/mRNA abundances in m. vastus lateralis
Time Frame: Change from baseline to after 6 training sessions
rRNA/RNA abundances measured in biopsies from m. vastus lateralis.
Change from baseline to after 6 training sessions
Protein abundances in m. vastus lateralis
Time Frame: Change from baseline to after the training period (10-12 weeks)
Protein abundances measured in biopsies from m. vastus lateralis.
Change from baseline to after the training period (10-12 weeks)
Protein abundance in m. vastus lateralis
Time Frame: Change from baseline to after 6 training sessions
Protein abundances measured in biopsies from m. vastus lateralis.
Change from baseline to after 6 training sessions
rDNA content in m. vastus lateralis
Time Frame: Measured at baseline
Ribosomal DNA content measured in m. vastus lateralis
Measured at baseline
rDNA content in m. vastus lateralis
Time Frame: Change from baseline to after the training period (10-12 weeks)
Ribosomal DNA content measured in m. vastus lateralis
Change from baseline to after the training period (10-12 weeks)
rDNA content in m. vastus lateralis, (mid)
Time Frame: Change from baseline to after 12 sessions
Ribosomal DNA content measured in m. vastus lateralis
Change from baseline to after 12 sessions
rDNA content, whole-blood
Time Frame: Measured at baseline
Ribosomal DNA content measured in whole-blood
Measured at baseline
rDNA content, whole-blood
Time Frame: Change from baseline to after the training period (10-12 weeks)
Ribosomal DNA content measured in whole-blood
Change from baseline to after the training period (10-12 weeks)
rDNA content, whole-blood (mid)
Time Frame: Change from baseline to after 12 sessions
Ribosomal DNA content measured in whole-blood
Change from baseline to after 12 sessions
Epigenetic traits, muscle
Time Frame: Measured at baseline
Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis
Measured at baseline
Epigenetic traits, muscle
Time Frame: Change from baseline to after the training period (10-12 weeks)
Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis
Change from baseline to after the training period (10-12 weeks)
Epigenetic traits, muscle
Time Frame: Change from baseline to after 12 sessions
Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis
Change from baseline to after 12 sessions
Blood pressure
Time Frame: Change from baseline to after the training period (10-12 weeks).
Resting blood pressure
Change from baseline to after the training period (10-12 weeks).
Hemoglobin mass
Time Frame: Change from baseline to after the training period (10-12 weeks).
Total hemoglobin mass measured using the carbon monoxide rebreathing method
Change from baseline to after the training period (10-12 weeks).
Glucose tolerance
Time Frame: Change from baseline to after the training period (10-12 weeks).
Blood glucose and endocrine responses to a 2h glucose tolerance test (75 g bolus of glucose).
Change from baseline to after the training period (10-12 weeks).
Systemic inflammation
Time Frame: Change from baseline to after the training period (10-12 weeks).
Systemic inflammation measured as blood markers such as C-reactive protein (CRP) in resting blood samples.
Change from baseline to after the training period (10-12 weeks).
Lipoproteins and lipids in blood
Time Frame: Change from baseline to after the training period (10-12 weeks)
Concentrations of various lipoproteins and lipids in blood measured using targeted metabolomics
Change from baseline to after the training period (10-12 weeks)
Hemoglobin glycosylation
Time Frame: Change from baseline to after the training period (10-12 weeks)
Long-term glucose levels measured as hemoglobin glycosylation
Change from baseline to after the training period (10-12 weeks)
Hormone concentrations in blood
Time Frame: Change from baseline to after the training period (10-12 weeks)
Concentrations of hormones such as testosterone, growth hormone, thyroid hormones, cortisol and insulin (c-peptide) in serum
Change from baseline to after the training period (10-12 weeks)
Health-related quality of life (SF-36)
Time Frame: Change from baseline to after the training period (10-12 weeks)
Health-related quality of life measured using the SF-36 questionnaire
Change from baseline to after the training period (10-12 weeks)
SARC-F
Time Frame: Measured at baseline
Sarcopenia score assessed using SARC-F (questionnaire)
Measured at baseline
SARC-F
Time Frame: Change from baseline to after the training period (10-12 weeks)
Sarcopenia score assessed using SARC-F (questionnaire)
Change from baseline to after the training period (10-12 weeks)
Dietary registration
Time Frame: Measured at baseline
Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake)
Measured at baseline
Dietary registration
Time Frame: Measured after 12 sessions
Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake)
Measured after 12 sessions
Training diary relating to the intervention protocol
Time Frame: Throughout the intervention (continuous)
Information about intervention-specific training, including training frequency, volume and load
Throughout the intervention (continuous)
Activities of daily living (questionnaire)
Time Frame: Measured at baseline
Activities of daily living measured using a questionnaire (i.e. time spent in activity, intensities and type of activity)
Measured at baseline
Daily activity level
Time Frame: Measured during the intervention
Daily activity level registred over three to five days using an accelerometer.
Measured during the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stian Ellefsen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sykehuset Innlandet HF

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stian Ellefsen, PhD, Inland Norway University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TR030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The full data sets used to analyze study outcomes will be made available with the publication of the study. Data sets will be included or referred to in the publication and hosted online.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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