SarcopeniaRELIEFNCT05063279
RELIEF - Resistance Training for Life
A study testing Progressive resistance training in people with Sarcopenia, run by Stian Ellefsen at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Progressive resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteNorway
- Study dates
- 6 Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages between 18 and 30 or > 70
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Sarcopenia
- Being tested
- Progressive resistance training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training group | Experimental | 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. Receives: Other: Progressive resistance training |
| Negative control group | No intervention | A negative control group is included in the study which will not receive any resistance training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle size, lower extremities
Muscle size of lower extremity knee extensors measured with magnetic resonance imaging (MRI).
Measured: Change from baseline to after the training period (10-12 weeks)
Secondary outcomes (7)
Muscle size, upper-body extremities
Muscle size of upper extremity elbow flexors measured with magnetic resonance imaging (MRI).
Measured: Change from baseline to after the training period (10-12 weeks)
Appendicular lean mass, lower-body extremities
Appendicular lean mass of the legs measured using Dual X-Ray Absorptiometry
Measured: Change from baseline to after the training period (10-12 weeks)
Appendicular lean mass, upper-body extremities
Appendicular lean mass of the arms measured using Dual X-Ray Absorptiometry
Measured: Change from baseline to after the training period (10-12 weeks)
Muscle thickness, m. vastus lateralis
Musle thickness of m. vastus lateralis measured using ultrasound
Measured: Change from baseline to after the training period (10-12 weeks)
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
Measured: Change from baseline to after the training period (10-12 weeks)
Muscle strength, upper-body extremities
Muscle strength of the arms measured as isometric force (elbow flexors; fixed angle)
Measured: Change from baseline to after the training period (10-12 weeks)
Muscular peak power/force, lower-body extremities
Muscular peak power/force measured using dynamic leg press
Measured: MeasurChange from baseline to after the training period (10-12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start6 Sep 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stian Ellefsen
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Responsible party
- Sponsor-investigator, Stian Ellefsen, Inland Norway University of Applied Sciences
- Investigators
- Stian Ellefsen, PhD, Principal investigator, Inland Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063279
- Sponsor's protocol ID
- TR030
- Acronym
- RELIEF
- Status last verified
- Aug 2024
- First submitted
- 11 Sep 2021
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05063279
- Acronym / sponsor ID
- RELIEF / TR030
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Stian EllefsenUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resistance training group | Experimental | Other: Progressive resistance trainingParticipants 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. |
| Negative control group | No intervention | –A negative control group is included in the study which will not receive any resistance training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages between 18 and 30 or > 70
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance trainingProgressive 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. | Other | Resistance training group |
Primary outcome
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).
7 secondary outcomes
Muscle size, upper-body extremities
Time frame: Change from baseline to after the training period (10-12 weeks)
Appendicular lean mass, lower-body extremities
Time frame: Change from baseline to after the training period (10-12 weeks)
Appendicular lean mass, upper-body extremities
Time frame: Change from baseline to after the training period (10-12 weeks)
Muscle thickness, m. vastus lateralis
Time frame: Change from baseline to after the training period (10-12 weeks)
Muscle strength, lower-body extremities
Time frame: Change from baseline to after the training period (10-12 weeks)
Muscle strength, upper-body extremities
Time frame: Change from baseline to after the training period (10-12 weeks)
Muscular peak power/force, lower-body extremities
Time frame: MeasurChange from baseline to after the training period (10-12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stian Ellefsen, PhD principal investigator
Inland Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training in people with Sarcopenia, run by Stian Ellefsen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle size, lower extremities (time frame: Change from baseline to after the training period (10-12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.