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Completed

NCT Number: NCT05063279

RELIEF - Resistance Training for Life

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inland Norway University of Applied Sciences

Lillehammer, 2624, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive resistance training

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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

Other outcomes

  1. Muscle thickness, m. vastus lateralis (mid)

    Time frame: Change from baseline to after 12 sessions

    Musle thickness of m. vastus lateralis measured using ultrasound

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. rDNA content in m. vastus lateralis

    Time frame: Measured at baseline

    Ribosomal DNA content measured in m. vastus lateralis

  16. 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

  17. rDNA content in m. vastus lateralis, (mid)

    Time frame: Change from baseline to after 12 sessions

    Ribosomal DNA content measured in m. vastus lateralis

  18. rDNA content, whole-blood

    Time frame: Measured at baseline

    Ribosomal DNA content measured in whole-blood

  19. rDNA content, whole-blood

    Time frame: Change from baseline to after the training period (10-12 weeks)

    Ribosomal DNA content measured in whole-blood

  20. rDNA content, whole-blood (mid)

    Time frame: Change from baseline to after 12 sessions

    Ribosomal DNA content measured in whole-blood

  21. Epigenetic traits, muscle

    Time frame: Measured at baseline

    Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis

  22. 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

  23. Epigenetic traits, muscle

    Time frame: Change from baseline to after 12 sessions

    Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis

  24. Blood pressure

    Time frame: Change from baseline to after the training period (10-12 weeks).

    Resting blood pressure

  25. 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

  26. 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).

  27. 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.

  28. 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

  29. Hemoglobin glycosylation

    Time frame: Change from baseline to after the training period (10-12 weeks)

    Long-term glucose levels measured as hemoglobin glycosylation

  30. 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

  31. 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

  32. SARC-F

    Time frame: Measured at baseline

    Sarcopenia score assessed using SARC-F (questionnaire)

  33. SARC-F

    Time frame: Change from baseline to after the training period (10-12 weeks)

    Sarcopenia score assessed using SARC-F (questionnaire)

  34. Dietary registration

    Time frame: Measured at baseline

    Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake)

  35. 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)

  36. Training diary relating to the intervention protocol

    Time frame: Throughout the intervention (continuous)

    Information about intervention-specific training, including training frequency, volume and load

  37. 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)

  38. Daily activity level

    Time frame: Measured during the intervention

    Daily activity level registred over three to five days using an accelerometer.

Sponsors and collaborators

Lead sponsor

Stian Ellefsen

Other

Collaborators

  • Sykehuset Innlandet HF

Registry information

Official study title

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

Acronym: RELIEF

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2021
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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