RELIEF - Resistance Training for Life

NCT05063279 | Completed DMC

• 1 other identifier: TR030
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Muscle size, lower extremities

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

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

Secondary Outcomes (7)

• Muscle size, upper-body extremities

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

• Appendicular lean mass, lower-body extremities

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

• Appendicular lean mass, upper-body extremities

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

• Muscle thickness, m. vastus lateralis

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

• Muscle strength, lower-body extremities

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

Other Outcomes (38)

• Muscle thickness, m. vastus lateralis (mid)

  Change from baseline to after 12 sessions

• Muscle strength, lower-body extremities (mid)

  Change from baseline to after 12 sessions

• Muscle strength, upper-body extremities (mid)

  Change from baseline to after 12 sessions

Study Arms (2)

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.

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.

Interventions

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.

Resistance training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages between 18 and 30 or \> 70

You may not qualify if:

• 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

Sponsors & Collaborators

• Stian Ellefsen: lead
• Sykehuset Innlandet HF: collaborator

Study Sites (1)

Inland Norway University of Applied Sciences

Lillehammer, 2624, Norway

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Stian Ellefsen, PhD

  Inland Norway University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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 Record Dates

• First Submitted: September 11, 2021
• First Posted: October 1, 2021
• Study Start: September 6, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

NO (1)