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RELIEF - Resistance Training for Life (RELIEF)

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Progressive resistance training
Sponsored by
Stian Ellefsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Inland Norway University of Applied SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance training group

Negative control group

Arm Description

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.

A negative control group is included in the study which will not receive any resistance training.

Outcomes

Primary Outcome Measures

Muscle size, lower extremities
Muscle size of lower extremity knee extensors measured with magnetic resonance imaging (MRI).

Secondary Outcome Measures

Muscle size, upper-body extremities
Muscle size of upper extremity elbow flexors measured with magnetic resonance imaging (MRI).
Appendicular lean mass, lower-body extremities
Appendicular lean mass of the legs measured using Dual X-Ray Absorptiometry
Appendicular lean mass, upper-body extremities
Appendicular lean mass of the arms measured using Dual X-Ray Absorptiometry
Muscle thickness, m. vastus lateralis
Musle thickness of m. vastus lateralis measured using ultrasound
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
Muscle strength, upper-body extremities
Muscle strength of the arms measured as isometric force (elbow flexors; fixed angle)
Muscular peak power/force, lower-body extremities
Muscular peak power/force measured using dynamic leg press

Full Information

First Posted
September 11, 2021
Last Updated
August 5, 2022
Sponsor
Stian Ellefsen
Collaborators
Sykehuset Innlandet HF
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1. Study Identification

Unique Protocol Identification Number
NCT05063279
Brief Title
RELIEF - Resistance Training for Life
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stian Ellefsen
Collaborators
Sykehuset Innlandet HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Negative control group
Arm Type
No Intervention
Arm Description
A negative control group is included in the study which will not receive any resistance training.
Intervention Type
Other
Intervention Name(s)
Progressive resistance training
Intervention Description
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 Outcome Measure Information:
Title
Muscle size, lower extremities
Description
Muscle size of lower extremity knee extensors measured with magnetic resonance imaging (MRI).
Time Frame
Change from baseline to after the training period (10-12 weeks)
Secondary Outcome Measure Information:
Title
Muscle size, upper-body extremities
Description
Muscle size of upper extremity elbow flexors measured with magnetic resonance imaging (MRI).
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Appendicular lean mass, lower-body extremities
Description
Appendicular lean mass of the legs measured using Dual X-Ray Absorptiometry
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Appendicular lean mass, upper-body extremities
Description
Appendicular lean mass of the arms measured using Dual X-Ray Absorptiometry
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Muscle thickness, m. vastus lateralis
Description
Musle thickness of m. vastus lateralis measured using ultrasound
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Muscle strength, lower-body extremities
Description
Muscle strength of the legs measured as a weighted average of lower body isokinetic and isometric knee extensor maximal force
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Muscle strength, upper-body extremities
Description
Muscle strength of the arms measured as isometric force (elbow flexors; fixed angle)
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Muscular peak power/force, lower-body extremities
Description
Muscular peak power/force measured using dynamic leg press
Time Frame
MeasurChange from baseline to after the training period (10-12 weeks)
Other Pre-specified Outcome Measures:
Title
Muscle thickness, m. vastus lateralis (mid)
Description
Musle thickness of m. vastus lateralis measured using ultrasound
Time Frame
Change from baseline to after 12 sessions
Title
Muscle strength, lower-body extremities (mid)
Description
Muscle strength will be assessed as a weighted average of lower body isokinetic and isometric knee extensor maximal force
Time Frame
Change from baseline to after 12 sessions
Title
Muscle strength, upper-body extremities (mid)
Description
Muscle strength of the arms measured as isometric force (elbow flexors; fixed angle)
Time Frame
Change from baseline to after 12 sessions
Title
Muscular peak power/force, lower-body extremities
Description
Muscular peak power/force measured using dynamic leg press
Time Frame
Change from baseline to after 12 sessions
Title
Muscle architecture, m. vastus lateralis (mid)
Description
Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound
Time Frame
Change from baseline to after 12 sessions
Title
Muscle architecture, m. vastus lateralis
Description
Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound
Time Frame
Change from baseline to the training period (10-12 weeks).
Title
Body composition
Description
Whole Body Dual X-Ray Absorptiometry to estimate lean mass, bone mineral density and fat mass.
Time Frame
Change from baseline to after the training period (10-12 weeks).
Title
Muscle fibre characteristics in m. vastus lateralis
Description
Muscle fiber characteristics such as muscle fiber proportions, cross-sectional area, myonuclei content and capillarization measured in biopsies from m. vastus lateralis
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Total-RNA abundance in m. vastus lateralis
Description
Total-RNA abundance measured in biopsies from m. vastus lateralis.
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Total-RNA abundance in m. vastus lateralis
Description
Total-RNA abundance measured in biopsies from m. vastus lateralis.
Time Frame
Change from baseline to after 6 training sessions
Title
rRNA/RNA abundances in m. vastus lateralis
Description
rRNA/RNA abundances measured in biopsies from m. vastus lateralis.
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
rRNA/mRNA abundances in m. vastus lateralis
Description
rRNA/RNA abundances measured in biopsies from m. vastus lateralis.
Time Frame
Change from baseline to after 6 training sessions
Title
Protein abundances in m. vastus lateralis
Description
Protein abundances measured in biopsies from m. vastus lateralis.
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Protein abundance in m. vastus lateralis
Description
Protein abundances measured in biopsies from m. vastus lateralis.
Time Frame
Change from baseline to after 6 training sessions
Title
rDNA content in m. vastus lateralis
Description
Ribosomal DNA content measured in m. vastus lateralis
Time Frame
Measured at baseline
Title
rDNA content in m. vastus lateralis
Description
Ribosomal DNA content measured in m. vastus lateralis
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
rDNA content in m. vastus lateralis, (mid)
Description
Ribosomal DNA content measured in m. vastus lateralis
Time Frame
Change from baseline to after 12 sessions
Title
rDNA content, whole-blood
Description
Ribosomal DNA content measured in whole-blood
Time Frame
Measured at baseline
Title
rDNA content, whole-blood
Description
Ribosomal DNA content measured in whole-blood
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
rDNA content, whole-blood (mid)
Description
Ribosomal DNA content measured in whole-blood
Time Frame
Change from baseline to after 12 sessions
Title
Epigenetic traits, muscle
Description
Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis
Time Frame
Measured at baseline
Title
Epigenetic traits, muscle
Description
Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Epigenetic traits, muscle
Description
Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis
Time Frame
Change from baseline to after 12 sessions
Title
Blood pressure
Description
Resting blood pressure
Time Frame
Change from baseline to after the training period (10-12 weeks).
Title
Hemoglobin mass
Description
Total hemoglobin mass measured using the carbon monoxide rebreathing method
Time Frame
Change from baseline to after the training period (10-12 weeks).
Title
Glucose tolerance
Description
Blood glucose and endocrine responses to a 2h glucose tolerance test (75 g bolus of glucose).
Time Frame
Change from baseline to after the training period (10-12 weeks).
Title
Systemic inflammation
Description
Systemic inflammation measured as blood markers such as C-reactive protein (CRP) in resting blood samples.
Time Frame
Change from baseline to after the training period (10-12 weeks).
Title
Lipoproteins and lipids in blood
Description
Concentrations of various lipoproteins and lipids in blood measured using targeted metabolomics
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Hemoglobin glycosylation
Description
Long-term glucose levels measured as hemoglobin glycosylation
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Hormone concentrations in blood
Description
Concentrations of hormones such as testosterone, growth hormone, thyroid hormones, cortisol and insulin (c-peptide) in serum
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Health-related quality of life (SF-36)
Description
Health-related quality of life measured using the SF-36 questionnaire
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
SARC-F
Description
Sarcopenia score assessed using SARC-F (questionnaire)
Time Frame
Measured at baseline
Title
SARC-F
Description
Sarcopenia score assessed using SARC-F (questionnaire)
Time Frame
Change from baseline to after the training period (10-12 weeks)
Title
Dietary registration
Description
Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake)
Time Frame
Measured at baseline
Title
Dietary registration
Description
Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake)
Time Frame
Measured after 12 sessions
Title
Training diary relating to the intervention protocol
Description
Information about intervention-specific training, including training frequency, volume and load
Time Frame
Throughout the intervention (continuous)
Title
Activities of daily living (questionnaire)
Description
Activities of daily living measured using a questionnaire (i.e. time spent in activity, intensities and type of activity)
Time Frame
Measured at baseline
Title
Daily activity level
Description
Daily activity level registred over three to five days using an accelerometer.
Time Frame
Measured during the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Hammarström, PhD
Phone
+4740555928
Email
daniel.hammarstrom@inn.no
First Name & Middle Initial & Last Name or Official Title & Degree
Stian Ellefsen, PhD
Email
stian.ellefsen@inn.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stian Ellefsen, PhD
Organizational Affiliation
Inland Norway University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inland Norway University of Applied Sciences
City
Lillehammer
ZIP/Postal Code
2624
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Hammarström, PhD
Phone
+4740555928
Email
daniel.hammarstrom@inn.no

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

RELIEF - Resistance Training for Life

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