RELIEF - Resistance Training for Life

Sarcopenia Clinical Trial

— RELIEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063279
• Other study ID #: TR030
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Inland Norway University of Applied Sciences
• Contact: Daniel Hammarström, PhD
• Phone: +4740555928
• Email: daniel.hammarstrom[@]inn.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Norway	Inland Norway University of Applied Sciences	Lillehammer

Sponsors (2)

Lead Sponsor	Collaborator
Stian Ellefsen	Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle thickness, m. vastus lateralis (mid)	Musle thickness of m. vastus lateralis measured using ultrasound	Change from baseline to after 12 sessions
Other	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
Other	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
Other	Muscular peak power/force, lower-body extremities	Muscular peak power/force measured using dynamic leg press	Change from baseline to after 12 sessions
Other	Muscle architecture, m. vastus lateralis (mid)	Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound	Change from baseline to after 12 sessions
Other	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).
Other	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).
Other	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)
Other	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)
Other	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
Other	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)
Other	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
Other	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)
Other	Protein abundance in m. vastus lateralis	Protein abundances measured in biopsies from m. vastus lateralis.	Change from baseline to after 6 training sessions
Other	rDNA content in m. vastus lateralis	Ribosomal DNA content measured in m. vastus lateralis	Measured at baseline
Other	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)
Other	rDNA content in m. vastus lateralis, (mid)	Ribosomal DNA content measured in m. vastus lateralis	Change from baseline to after 12 sessions
Other	rDNA content, whole-blood	Ribosomal DNA content measured in whole-blood	Measured at baseline
Other	rDNA content, whole-blood	Ribosomal DNA content measured in whole-blood	Change from baseline to after the training period (10-12 weeks)
Other	rDNA content, whole-blood (mid)	Ribosomal DNA content measured in whole-blood	Change from baseline to after 12 sessions
Other	Epigenetic traits, muscle	Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis	Measured at baseline
Other	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)
Other	Epigenetic traits, muscle	Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis	Change from baseline to after 12 sessions
Other	Blood pressure	Resting blood pressure	Change from baseline to after the training period (10-12 weeks).
Other	Hemoglobin mass	Total hemoglobin mass measured using the carbon monoxide rebreathing method	Change from baseline to after the training period (10-12 weeks).
Other	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).
Other	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).
Other	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)
Other	Hemoglobin glycosylation	Long-term glucose levels measured as hemoglobin glycosylation	Change from baseline to after the training period (10-12 weeks)
Other	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)
Other	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)
Other	SARC-F	Sarcopenia score assessed using SARC-F (questionnaire)	Measured at baseline
Other	SARC-F	Sarcopenia score assessed using SARC-F (questionnaire)	Change from baseline to after the training period (10-12 weeks)
Other	Dietary registration	Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake)	Measured at baseline
Other	Dietary registration	Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake)	Measured after 12 sessions
Other	Training diary relating to the intervention protocol	Information about intervention-specific training, including training frequency, volume and load	Throughout the intervention (continuous)
Other	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
Other	Daily activity level	Daily activity level registred over three to five days using an accelerometer.	Measured during the intervention
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)