CClinicalTrials.gg
SuspendedNCT05111054EIMD-LOADUpdated Nov 16, 2021

Sex Differences in Muscle Damage Following Resistance Exercise at Low or High Intensity

An interventional study of Resistance Exercise in Muscle Damage, sponsored by Durham University. Suspended at 1 site in United Kingdom. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-16.

Sponsored by Durham University · Not applicable, Interventional, and Basic science

Why this study was suspended
Time availability within PhD studentship
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Muscle Damage
03

In context

Lead sponsor

Durham University is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Low-Load

    Acute resistance exercise performed at 30% 1RM

    Other: Resistance Exercise

  • Active comparator
    High-Load

    Acute resistance exercise performed at 80% 1RM

    Other: Resistance Exercise

Interventions

  • OtherResistance Exercise

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

06

What researchers measure

Primary outcomes

  1. Maximal Voluntary Contraction at baseline

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

    Time frame: Baseline

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

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

    Time frame: 72-hours after the exercise bout

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

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

    Time frame: 168-hours after the exercise bout

  4. Creatine kinase concentration at baseline

    Serum concentration of creatine kinase from venous blood sampling

    Time frame: Immediately pre-exercise

  5. Change from baseline in Creatine Kinase concentration immediately post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    Time frame: Immediately after the exercise bout

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

    Serum concentration of creatine kinase from venous blood sampling

    Time frame: 24-hours after the exercise bout

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

    Serum concentration of creatine kinase from venous blood sampling

    Time frame: 48-hours after the exercise bout

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

    Serum concentration of creatine kinase from venous blood sampling

    Time frame: 72-hours after the exercise bout

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

    Serum concentration of creatine kinase from venous blood sampling

    Time frame: 168-hours after the exercise bout

  10. Interleukin-6 concentration at baseline

    Serum concentration of Interleukin-6 from venous blood sampling

    Time frame: Immediately pre-exercise

  11. Change from baseline in Interleukin-6 concentration immediately post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    Time frame: Immediately after the exercise bout

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

    Serum concentration of Interleukin-6 from venous blood sampling

    Time frame: 24-hours after the exercise bout

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

    Serum concentration of Interleukin-6 from venous blood sampling

    Time frame: 48-hours after the exercise bout

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

    Serum concentration of Interleukin-6 from venous blood sampling

    Time frame: 72-hours after the exercise bout

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

    Serum concentration of Interleukin-6 from venous blood sampling

    Time frame: 168-hours after the exercise bout

  16. Muscle soreness (pressure algometry) at baseline

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

    Time frame: Immediately pre-exercise

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

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

    Time frame: Immediately after the exercise bout

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

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

    Time frame: 24-hours after the exercise bout

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

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

    Time frame: 48-hours after the exercise bout

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

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

    Time frame: 72-hours after the exercise bout

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

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

    Time frame: 168-hours after the exercise bout

  22. 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)

    Time frame: Immediately pre-exercise

  23. 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)

    Time frame: Immediately after the exercise bout

  24. 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)

    Time frame: 24-hours after the exercise bout

  25. 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)

    Time frame: 48-hours after the exercise bout

  26. 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)

    Time frame: 72-hours after the exercise bout

  27. 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)

    Time frame: 168-hours after the exercise bout

  28. Range of motion at baseline

    Flexibility of the exercised limb as determined by goniometry

    Time frame: Immediately pre-exercise

  29. Change in range of motion immediately post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Time frame: Immediately after the exercise bout

  30. Change in range of motion at 24-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Time frame: 24-hours after the exercise bout

  31. Change in range of motion at 48-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Time frame: 48-hours after the exercise bout

  32. Change in range of motion at 72-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Time frame: 72-hours after the exercise bout

  33. Change in range of motion at 168-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Time frame: 168-hours after the exercise bout

  34. Limb circumference at baseline

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

    Time frame: Immediately pre-exercise

  35. Change in limb circumference immediately post-exercise

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

    Time frame: Immediately after the exercise bout

  36. Change in limb circumference at 24-hours post-exercise

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

    Time frame: 24-hours after the exercise bout

  37. Change in limb circumference at 48-hours post-exercise

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

    Time frame: 48-hours after the exercise bout

  38. Change in limb circumference at 72-hours post-exercise

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

    Time frame: 72-hours after the exercise bout

  39. Change in limb circumference at 168-hours post-exercise

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

    Time frame: 168-hours after the exercise bout

07

Study locations

1 site
  • Durham University, The Graham Sports Centre
    Durham, County Durham DH1 3HN, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05111054
Lead sponsor
Durham University
Responsible party
Alice Pearson (Principal Investigator, Durham University) — Principal investigator
First posted
Nov 8, 2021
Start date
Jan 2023 (estimated)
Primary completion
Jan 2024 (estimated)
Completion
Jan 2024 (estimated)
Last update
Nov 16, 2021

Study contacts

Alice G Pearson
principal investigator · Durham University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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