Clinical trial NCT05063279: RELIEF - Resistance Training for Life
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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Inland Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
First posted: 2021-10-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Muscle size, lower extremities
timeFrame: Change from baseline to after the training period (10-12 weeks)
Secondary outcomes:
measure: Muscle size, upper-body extremities
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Appendicular lean mass, lower-body extremities
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Appendicular lean mass, upper-body extremities
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Muscle thickness, m. vastus lateralis
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Muscle strength, lower-body extremities
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Muscle strength, upper-body extremities
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Muscular peak power/force, lower-body extremities
timeFrame: MeasurChange from baseline to after the training period (10-12 weeks)
Other outcomes:
measure: Muscle thickness, m. vastus lateralis (mid)
timeFrame: Change from baseline to after 12 sessions
measure: Muscle strength, lower-body extremities (mid)
timeFrame: Change from baseline to after 12 sessions
measure: Muscle strength, upper-body extremities (mid)
timeFrame: Change from baseline to after 12 sessions
measure: Muscular peak power/force, lower-body extremities
timeFrame: Change from baseline to after 12 sessions
measure: Muscle architecture, m. vastus lateralis (mid)
timeFrame: Change from baseline to after 12 sessions
measure: Muscle architecture, m. vastus lateralis
timeFrame: Change from baseline to the training period (10-12 weeks).
measure: Body composition
timeFrame: Change from baseline to after the training period (10-12 weeks).
measure: Muscle fibre characteristics in m. vastus lateralis
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Total-RNA abundance in m. vastus lateralis
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Total-RNA abundance in m. vastus lateralis
timeFrame: Change from baseline to after 6 training sessions
measure: rRNA/RNA abundances in m. vastus lateralis
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: rRNA/mRNA abundances in m. vastus lateralis
timeFrame: Change from baseline to after 6 training sessions
measure: Protein abundances in m. vastus lateralis
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Protein abundance in m. vastus lateralis
timeFrame: Change from baseline to after 6 training sessions
measure: rDNA content in m. vastus lateralis
timeFrame: Measured at baseline
measure: rDNA content in m. vastus lateralis
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: rDNA content in m. vastus lateralis, (mid)
timeFrame: Change from baseline to after 12 sessions
measure: rDNA content, whole-blood
timeFrame: Measured at baseline
measure: rDNA content, whole-blood
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: rDNA content, whole-blood (mid)
timeFrame: Change from baseline to after 12 sessions
measure: Epigenetic traits, muscle
timeFrame: Measured at baseline
measure: Epigenetic traits, muscle
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Epigenetic traits, muscle
timeFrame: Change from baseline to after 12 sessions
measure: Blood pressure
timeFrame: Change from baseline to after the training period (10-12 weeks).
measure: Hemoglobin mass
timeFrame: Change from baseline to after the training period (10-12 weeks).
measure: Glucose tolerance
timeFrame: Change from baseline to after the training period (10-12 weeks).
measure: Systemic inflammation
timeFrame: Change from baseline to after the training period (10-12 weeks).
measure: Lipoproteins and lipids in blood
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Hemoglobin glycosylation
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Hormone concentrations in blood
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Health-related quality of life (SF-36)
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: SARC-F
timeFrame: Measured at baseline
measure: SARC-F
timeFrame: Change from baseline to after the training period (10-12 weeks)
measure: Dietary registration
timeFrame: Measured at baseline
measure: Dietary registration
timeFrame: Measured after 12 sessions
measure: Training diary relating to the intervention protocol
timeFrame: Throughout the intervention (continuous)
measure: Activities of daily living (questionnaire)
timeFrame: Measured at baseline
measure: Daily activity level
timeFrame: Measured during the intervention
Locations:
city: Lillehammer
country: Norway
facility: Inland Norway University of Applied Sciences
Study officials:
affiliation: Inland Norway University of Applied Sciences
name: Stian Ellefsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: