RELIEF - Resistance Training for Life

Sponsor
Stian Ellefsen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05063279
Collaborator
Sykehuset Innlandet HF (Other)
60
1
2
15.8
3.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Progressive resistance training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Study conditions (exercise volume) are randomized to either leg/arm for within-participant comparisons. The effect of age is assessed from two parallel age groups.Study conditions (exercise volume) are randomized to either leg/arm for within-participant comparisons. The effect of age is assessed from two parallel age groups.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Study conditions (exercise volume) and age groups identifiers are omitted from outcome assessments whenever possible. Assessment of the primary (and selected secondary) outcome(s) will be performed in a blinded fashion by assessors/investigators.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Sep 6, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Muscle size, lower extremities [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 Outcome Measures

  1. Muscle size, upper-body extremities [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 [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 [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 [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 [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 [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 [MeasurChange from baseline to after the training period (10-12 weeks)]

    Muscular peak power/force measured using dynamic leg press

Other Outcome Measures

  1. Muscle thickness, m. vastus lateralis (mid) [Change from baseline to after 12 sessions]

    Musle thickness of m. vastus lateralis measured using ultrasound

  2. Muscle strength, lower-body extremities (mid) [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) [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 [Change from baseline to after 12 sessions]

    Muscular peak power/force measured using dynamic leg press

  5. Muscle architecture, m. vastus lateralis (mid) [Change from baseline to after 12 sessions]

    Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound

  6. Muscle architecture, m. vastus lateralis [Change from baseline to the training period (10-12 weeks).]

    Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound

  7. Body composition [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 [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 [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 [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 [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 [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 [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 [Change from baseline to after 6 training sessions]

    Protein abundances measured in biopsies from m. vastus lateralis.

  15. rDNA content in m. vastus lateralis [Measured at baseline]

    Ribosomal DNA content measured in m. vastus lateralis

  16. rDNA content in m. vastus lateralis [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) [Change from baseline to after 12 sessions]

    Ribosomal DNA content measured in m. vastus lateralis

  18. rDNA content, whole-blood [Measured at baseline]

    Ribosomal DNA content measured in whole-blood

  19. rDNA content, whole-blood [Change from baseline to after the training period (10-12 weeks)]

    Ribosomal DNA content measured in whole-blood

  20. rDNA content, whole-blood (mid) [Change from baseline to after 12 sessions]

    Ribosomal DNA content measured in whole-blood

  21. Epigenetic traits, muscle [Measured at baseline]

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

  22. Epigenetic traits, muscle [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 [Change from baseline to after 12 sessions]

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

  24. Blood pressure [Change from baseline to after the training period (10-12 weeks).]

    Resting blood pressure

  25. Hemoglobin mass [Change from baseline to after the training period (10-12 weeks).]

    Total hemoglobin mass measured using the carbon monoxide rebreathing method

  26. Glucose tolerance [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 [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 [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 [Change from baseline to after the training period (10-12 weeks)]

    Long-term glucose levels measured as hemoglobin glycosylation

  30. Hormone concentrations in blood [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) [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 [Measured at baseline]

    Sarcopenia score assessed using SARC-F (questionnaire)

  33. SARC-F [Change from baseline to after the training period (10-12 weeks)]

    Sarcopenia score assessed using SARC-F (questionnaire)

  34. Dietary registration [Measured at baseline]

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

  35. Dietary registration [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 [Throughout the intervention (continuous)]

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

  37. Activities of daily living (questionnaire) [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 [Measured during the intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inland Norway University of Applied Sciences Lillehammer Norway 2624

Sponsors and Collaborators

  • Stian Ellefsen
  • Sykehuset Innlandet HF

Investigators

  • Principal Investigator: Stian Ellefsen, PhD, Inland Norway University of Applied Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stian Ellefsen, Professor, Inland Norway University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT05063279
Other Study ID Numbers:
  • TR030
First Posted:
Oct 1, 2021
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022