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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05063279
Other study ID # TR030
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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