RELIEF - Resistance Training for Life (RELIEF)

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: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Progressive resistance training

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Muscle size, lower extremities	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

Outcome Measure	Measure Description	Time Frame
Muscle size, upper-body extremities	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	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	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	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	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	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	Muscular peak power/force measured using dynamic leg press	MeasurChange from baseline to after the training period (10-12 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle thickness, m. vastus lateralis (mid)	Musle thickness of m. vastus lateralis measured using ultrasound	Change from baseline to after 12 sessions
Muscle strength, lower-body extremities (mid)	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)	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	Muscular peak power/force measured using dynamic leg press	Change from baseline to after 12 sessions
Muscle architecture, m. vastus lateralis (mid)	Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound	Change from baseline to after 12 sessions
Muscle architecture, m. vastus lateralis	Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound	Change from baseline to the training period (10-12 weeks).
Body composition	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	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	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	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	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	rRNA/RNA abundances measured in biopsies from m. vastus lateralis.	Change from baseline to after 6 training sessions
Protein abundances in m. vastus lateralis	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	Protein abundances measured in biopsies from m. vastus lateralis.	Change from baseline to after 6 training sessions
rDNA content in m. vastus lateralis	Ribosomal DNA content measured in m. vastus lateralis	Measured at baseline
rDNA content in m. vastus lateralis	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)	Ribosomal DNA content measured in m. vastus lateralis	Change from baseline to after 12 sessions
rDNA content, whole-blood	Ribosomal DNA content measured in whole-blood	Measured at baseline
rDNA content, whole-blood	Ribosomal DNA content measured in whole-blood	Change from baseline to after the training period (10-12 weeks)
rDNA content, whole-blood (mid)	Ribosomal DNA content measured in whole-blood	Change from baseline to after 12 sessions
Epigenetic traits, muscle	Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis	Measured at baseline
Epigenetic traits, muscle	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	Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis	Change from baseline to after 12 sessions
Blood pressure	Resting blood pressure	Change from baseline to after the training period (10-12 weeks).
Hemoglobin mass	Total hemoglobin mass measured using the carbon monoxide rebreathing method	Change from baseline to after the training period (10-12 weeks).
Glucose tolerance	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	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	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	Long-term glucose levels measured as hemoglobin glycosylation	Change from baseline to after the training period (10-12 weeks)
Hormone concentrations in blood	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)	Health-related quality of life measured using the SF-36 questionnaire	Change from baseline to after the training period (10-12 weeks)
SARC-F	Sarcopenia score assessed using SARC-F (questionnaire)	Measured at baseline
SARC-F	Sarcopenia score assessed using SARC-F (questionnaire)	Change from baseline to after the training period (10-12 weeks)
Dietary registration	Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake)	Measured at baseline
Dietary registration	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	Information about intervention-specific training, including training frequency, volume and load	Throughout the intervention (continuous)
Activities of daily living (questionnaire)	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	Daily activity level registred over three to five days using an accelerometer.	Measured during the intervention

Collaborators and Investigators

• Sponsor: Stian Ellefsen
• Collaborators: Sykehuset Innlandet HF
• Investigators: Principal Investigator: Stian Ellefsen, PhD, Inland Norway University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID 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