NCT05111054

Brief Summary

Purpose: To investigate the impact of exercise load on resistance exercise-induced muscle damage in untrained males and females. Rationale: Unaccustomed resistance exercise can cause muscle damage, presenting as muscle soreness and reduced muscle function - such as loss of strength, power, and flexibility - for several days after the exercise bout. Therefore, individuals may require longer recovery periods before performing another exercise bout, and their performance may be impaired. Further, muscle soreness may reduce exercise compliance, particularly in novice individuals. Over time, this may compromise the gains in muscle mass and strength achieved through exercise training. Therefore, strategies to reduce the severity of exercise-induced muscle damage and/or to enhance post-exercise recovery processes are advantageous for exercising individuals. One such strategy is to perform resistance exercise with lighter loads, i.e. \<70% one repetition maximum (1RM). Low-load resistance training has shown to induce comparable gains in muscle mass and strength to high-load (≥70% 1RM), while being perceptively less exerting. Low-load resistance exercise may place less mechanical stress on muscle fibres and accordingly, its impact on muscle damage has been investigated. While several studies have reported less severe muscle damage, muscle soreness, and functional impairments with low-load resistance exercise compared to high-load, others have found no differences. Further, there is a lack of studies conducted solely in females or comparing between sexes. It has been suggested that males and females respond differently to muscle damage, and therefore, this research aims to provide a sex comparison in the muscle damage response to an acute bout of resistance exercise performed with low or high loads. Therefore, 40 healthy, young (18-35 years) adults (20 males, 20 females) will be recruited to participate in this randomised controlled trial. Maximal leg strength and body composition (by dual-energy X-ray absorptiometry; DXA) will be conducted at baseline. In females, all primary outcome measures will be obtained during the late follicular phase of the menstrual cycle. Participants will then be randomised to a low-load (30% 1RM) or high-load (80% 1RM) exercise condition. Three weeks later, participants will complete a resistance exercise session at their allocated intensity on leg extension and leg curl machines to induce muscle damage. Various measures of muscle damage (blood biomarkers, muscle soreness, flexibility, and swelling) will be obtained before, immediately after, and 24, 48, 72, and 168 h after the exercise protocol. The maximal strength test will be repeated 72 and 168 h after the exercise. Participants' habitual activity and dietary intake will be monitored and controlled throughout the study period. Expected outcome: It is expected that the resistance exercise protocol will induce muscle damage, which will be less severe in the low-load exercise condition. It cannot be ascertained whether males and females will have the same responses to the exercise.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

October 27, 2021

Last Update Submit

November 8, 2021

Conditions

Outcome Measures

Primary Outcomes (39)

  • Maximal Voluntary Contraction at baseline

    One-repetition maximum (1RM) test: leg extension and leg curl machines

    Baseline

  • Change from baseline Maximal Voluntary Contraction at 72-hours post-exercise

    One-repetition maximum (1RM) test: leg extension and leg curl machines

    72-hours after the exercise bout

  • Change from baseline Maximal Voluntary Contraction at 168-hours post-exercise

    One-repetition maximum (1RM) test: leg extension and leg curl machines

    168-hours after the exercise bout

  • Creatine kinase concentration at baseline

    Serum concentration of creatine kinase from venous blood sampling

    Immediately pre-exercise

  • Change from baseline in Creatine Kinase concentration immediately post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    Immediately after the exercise bout

  • Change from baseline in Creatine Kinase concentration at 24-hours post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    24-hours after the exercise bout

  • Change from baseline in Creatine Kinase concentration at 48-hours post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    48-hours after the exercise bout

  • Change from baseline in Creatine Kinase concentration at 72-hours post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    72-hours after the exercise bout

  • Change from baseline in Creatine Kinase concentration at 168-hours post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    168-hours after the exercise bout

  • Interleukin-6 concentration at baseline

    Serum concentration of Interleukin-6 from venous blood sampling

    Immediately pre-exercise

  • Change from baseline in Interleukin-6 concentration immediately post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    Immediately after the exercise bout

  • Change from baseline in Interleukin-6 concentration at 24-hours post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    24-hours after the exercise bout

  • Change from baseline in Interleukin-6 concentration at 48-hours post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    48-hours after the exercise bout

  • Change from baseline in Interleukin-6 concentration at 72-hours post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    72-hours after the exercise bout

  • Change from baseline in Interleukin-6 concentration at 168-hours post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    168-hours after the exercise bout

  • Muscle soreness (pressure algometry) at baseline

    Self-perceived rating of muscle soreness with use of pressure algometry

    Immediately pre-exercise

  • Change in muscle soreness (pressure algometry) immediately post-exercise

    Self-perceived rating of muscle soreness with use of pressure algometry

    Immediately after the exercise bout

  • Change in muscle soreness (pressure algometry) at 24-hours post-exercise

    Self-perceived rating of muscle soreness with use of pressure algometry

    24-hours after the exercise bout

  • Change in muscle soreness (pressure algometry) at 48-hours post-exercise

    Self-perceived rating of muscle soreness with use of pressure algometry

    48-hours after the exercise bout

  • Change in muscle soreness (pressure algometry) at 72-hours post-exercise

    Self-perceived rating of muscle soreness with use of pressure algometry

    72-hours after the exercise bout

  • Change in muscle soreness (pressure algometry) at 168-hours post-exercise

    Self-perceived rating of muscle soreness with use of pressure algometry

    168-hours after the exercise bout

  • Muscle soreness (visual analogue scale, VAS) at baseline

    Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale (0 - not sore at all, 10 - extremely sore)

    Immediately pre-exercise

  • Change in muscle soreness (visual analogue scale, VAS) immediately post-exercise

    Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale (0 - not sore at all, 10 - extremely sore)

    Immediately after the exercise bout

  • Change in muscle soreness (visual analogue scale, VAS) at 24-hours post-exercise

    Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale (0 - not sore at all, 10 - extremely sore)

    24-hours after the exercise bout

  • Change in muscle soreness (visual analogue scale, VAS) at 48-hours post-exercise

    Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale (0 - not sore at all, 10 - extremely sore)

    48-hours after the exercise bout

  • Change in muscle soreness (visual analogue scale, VAS) at 72-hours post-exercise

    Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale (0 - not sore at all, 10 - extremely sore)

    72-hours after the exercise bout

  • Change in muscle soreness (visual analogue scale, VAS) at 168-hours post-exercise

    Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale (0 - not sore at all, 10 - extremely sore)

    168-hours after the exercise bout

  • Range of motion at baseline

    Flexibility of the exercised limb as determined by goniometry

    Immediately pre-exercise

  • Change in range of motion immediately post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Immediately after the exercise bout

  • Change in range of motion at 24-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    24-hours after the exercise bout

  • Change in range of motion at 48-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    48-hours after the exercise bout

  • Change in range of motion at 72-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    72-hours after the exercise bout

  • Change in range of motion at 168-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    168-hours after the exercise bout

  • Limb circumference at baseline

    Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling

    Immediately pre-exercise

  • Change in limb circumference immediately post-exercise

    Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling

    Immediately after the exercise bout

  • Change in limb circumference at 24-hours post-exercise

    Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling

    24-hours after the exercise bout

  • Change in limb circumference at 48-hours post-exercise

    Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling

    48-hours after the exercise bout

  • Change in limb circumference at 72-hours post-exercise

    Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling

    72-hours after the exercise bout

  • Change in limb circumference at 168-hours post-exercise

    Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling

    168-hours after the exercise bout

Study Arms (2)

Low-Load

EXPERIMENTAL

Acute resistance exercise performed at 30% 1RM

Other: Resistance Exercise

High-Load

ACTIVE COMPARATOR

Acute resistance exercise performed at 80% 1RM

Other: Resistance Exercise

Interventions

Acute leg-based resistance exercise bout (3 sets performed to volitional failure on leg extension and leg curl machines)

High-LoadLow-Load

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18.5 - 25.0 kg/m2
  • Untrained in resistance exercise
  • No known chronic disease or current acute illness
  • No current or recent (past 3 months) musculoskeletal injury
  • No frequent use (2x per week for past month) of non-steroidal anti-inflammatory drugs, anti-oxidant supplements, polyunsaturated omega-3 fatty acids (and other substances that may alleviate muscle damage) and compliant to abstain from use during experimental period
  • No recent or current engagement in massage or cryotherapy and compliant to abstain from use during experimental period
  • Females will be eumenorrheic (regular menstrual cycle) \>12 months
  • Absence of pregnancy and breast-feeding

You may not qualify if:

  • Underweight
  • Overweight/obese
  • Resistance trained
  • Current or recent injury
  • Pregnancy or breast-feeding
  • Unwilling to provide blood samples, perform resistance exercise, or abstain from use of NSAID's and other substances (stated above)
  • Unwilling to abstain from other forms of exercise during the experimental period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham University, The Graham Sports Centre

Durham, County Durham, DH1 3HN, United Kingdom

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alice G Pearson

    Durham University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 8, 2021

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations