NCT04201977

Brief Summary

Delayed onset muscle soreness (DOMS) and decrease of musculoskeletal function are due to high intensity training and / or sports activities. These occur due to micro lesions of muscle tissue resulting in nociceptor sensitization. Non-pharmacological interventions to attenuate DOMS and favor muscle recovery have been studied. These interventions aim to maintain performance levels, especially in competitions. Among these interventions, cryotherapy (cold water immersion) and active recovery already have good clinical evidence. Currently a new proposal has been gaining ground for myofascial self-release (foam roller), however its mechanisms and clinical evidence are not yet well established. The aim of the present research is to compare the effects of passive recovery, active recovery, cold water immersion recovery and recovery through myofascial self-release on DOMS and the functionality of healthy volunteers undergoing resistance exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

December 10, 2019

Last Update Submit

April 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Isometric peak torque

    Isometric peak torque will be measured by a load cell of a tensile-compression dynamometer (EMGSystem, São José dos Campos, Brazil), with a capacity of 500 Kgf and a resolution of 0.1 kg, a set of fixing cables, a A/D converter board (EMGSystem, São José dos Campos, Brazil), connected to a computer and analyzed by the software EMGSystem Lab V1.2\_ 2010. For each muscle group, a minimum of 4 and a maximum of 10 measurements of each movement will be performed. This variation in the number of measurements is so that the last measurement is not the highest value during the test and so that the three highest values differ by less than 5%. For analysis will be considered the highest value (NELLESSEN et al., 2015). During the evaluations, standardized and vigorous verbal encouragement will be performed during the maneuver, with the aim of stimulating the individual to exert maximum effort during the entire muscle contraction time.Data will be presented in kgf.

    30 minutes after the interventions

Secondary Outcomes (9)

  • Subjective exertion perception

    30 minutes after the interventions

  • Flexibility

    30 minutes after the interventions

  • Muscle power

    30 minutes after the interventions

  • Agility

    30 minutes after the interventions

  • Speed

    30 minutes after the interventions

  • +4 more secondary outcomes

Study Arms (4)

Exercise session followed passive recovery

ACTIVE COMPARATOR

Prior each to the exercises sessions (4), volunteers will undergo specific warm-up in each exercise adopted (a series of 15 repetitions with 40% of the maximum load obtained in the 10RM test). The exercise sessions will consist of four sets for 10RM, with an interval of one minute between sets and two minutes between exercises. The exercise sequence (extension chair, squat and leg press) will be randomized through a closed brown envelope draw. Prior to the 10RM test and data collection, standardized instructions regarding the experimental procedure and exercise technique will be provided. Verbal stimuli to the volunteer will be performed during the evaluations and exercises (TEIXEIRA et al., 2014a, 2014b). The interval between each exercise session will be one week. Volunteers will not perform any form of recovery for 20 min after resistance exercise session (TEIXEIRA et al., 2014a, 2014b).

Other: Passive recovery

Exercise session followed active recovery

ACTIVE COMPARATOR

The interval between each exercise session will be one week. Prior each to the exercises sessions (4), volunteers will undergo specific warm-up in each exercise adopted (a series of 15 repetitions with 40% of the maximum load obtained in the 10RM test). The exercise sessions will consist of four sets for 10RM, with an interval of one minute between sets and two minutes between exercises. The exercise sequence (extension chair, squat and leg press) will be randomized through a closed brown envelope draw. Prior to the 10RM test and data collection, standardized instructions regarding the experimental procedure and exercise technique will be provided. Verbal stimuli to the volunteer will be performed during the evaluations and exercises (TEIXEIRA et al., 2014a, 2014b). Active recovery for 20 minutes (MIKA et al., 2016; CRISAFULLI et al., 2003; FAIRCHILD et al., 2003; VANDERTHOMMED; MAKROF; DEMOULIN, 2010);

Other: Active recovery

Exercise session followed immersion in cold water recovery

ACTIVE COMPARATOR

The interval between each exercise session will be one week. Prior each to the exercises sessions (4), volunteers will undergo specific warm-up in each exercise adopted (a series of 15 repetitions with 40% of the maximum load obtained in the 10RM test). The exercise sessions will consist of four sets for 10RM, with an interval of one minute between sets and two minutes between exercises. The exercise sequence (extension chair, squat and leg press) will be randomized through a closed brown envelope draw. Prior to the 10RM test and data collection, standardized instructions regarding the experimental procedure and exercise technique will be provided. Verbal stimuli to the volunteer will be performed during the evaluations and exercises (TEIXEIRA et al., 2014a, 2014b). Volunteers will be immersed in cold water immediately after exercise protocol (MACHADO et al., 2016b; MCDERMOTT et al., 2009).

Other: Immersion in cold water

Exercise session followed foam roller recovery

ACTIVE COMPARATOR

The interval between each exercise session will be one week. Prior each to the exercises sessions (4), volunteers will undergo specific warm-up in each exercise adopted (a series of 15 repetitions with 40% of the maximum load obtained in the 10RM test). The exercise sessions will consist of four sets for 10RM, with an interval of one minute between sets and two minutes between exercises. The exercise sequence (extension chair, squat and leg press) will be randomized through a closed brown envelope draw. Prior to the 10RM test and data collection, standardized instructions regarding the experimental procedure and exercise technique will be provided. Verbal stimuli to the volunteer will be performed during the evaluations and exercises (TEIXEIRA et al., 2014a, 2014b). Volunteers will undergo an FR session immediately after resistance exercise session (PEARCEY et al., 2015).

Other: Foam Roller Recovery

Interventions

Myofascial self-release will be developed through the foam roller (FR), where participants will use a custom-made foam roller constructed from a hollow polyvinyl chloride tube that will have an outside diameter of 10cm and a thickness of 0.5cm and will be surrounded by neoprene foam with a thickness of 1cm. Each volunteer will be shown the technique for the 5 muscle groups involved and the technique used for each muscle group. FR will consist of 45s of rolling for each muscle in the left lower extremity, 15s of rest, 45s in the lower right extremity. They will be instructed to begin with the practice on the most distal portion of the muscle. They will be instructed to place as much tolerable body mass on the FR at all times and to roll their body mass back and forth along the roller as smoothly as possible at a rate of 50 beats per minute (ie , 1 rolling motion for 1 to 2s). The total technique time is estimated at 10 to 15min (PEARCEY et al., 2015).

Also known as: Self-massage, Foam Roller
Exercise session followed foam roller recovery

Active recovery for 20 minutes (MIKA et al., 2016) will consist of pedaling on a stationary bike at a speed of 50 to 60 rpm. The load (49 ± 9 W) will be adjusted individually so that the heart rate is close to 100 bpm (about 50% of the theoretical maximum heart rate). This effort intensity is similar to that used in the literature (CRISAFULLI et al., 2003; FAIRCHILD et al., 2003; VANDERTHOMMED; MAKROF; DEMOULIN, 2010)

Also known as: Exercise
Exercise session followed active recovery

Immersion in cold water will consist of the individual sitting in a plastic pool with water at the water level of the umbilical scar. Water temperature is between 11 and 15ºC, for a period between 10 and 15 minutes immediately after the exercise protocol (MACHADO et al., 2016b; MCDERMOTT et al., 2009). Water temperature will be controlled by adding or removing ice. This method has been applied by studies conducted by our research group (MISSAU; SIGNORI, 2017).

Also known as: Cryotherapy
Exercise session followed immersion in cold water recovery

Volunteers will be seated for 20 min after the resistance exercise session (TEIXEIRA et al., 2014a, 2014b).

Also known as: Control
Exercise session followed passive recovery

Eligibility Criteria

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

You may qualify if:

  • Male,
  • Literate,
  • Normotensive volunteers,
  • Aged minimum18 to maximum 35 years old,
  • Physically active (IPAQ scale).
  • Body mass index (BMI: kg / m2) greater than 30

You may not qualify if:

  • Use of food supplements and medication
  • Consume alcoholic beverages (+ once a week)
  • Present of musculoskeletal disorders,
  • Previous diagnosis of diseases (rheumatologic, cardiovascular diseases, as well as neurological, oncological, immunological and hematological diseases)
  • Psychiatric and / or cognitive problems.
  • On the day of the exams will be excluded:
  • Volunteers who present symptoms of musculoskeletal disorders,
  • Consume ergogenic substances (24h),
  • Consume alcoholic beverages and foods containing alcohol or caffeine (24h)
  • Have performedintense physical activities 72 hours before the exam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luis Ulisses Signori

Santa Maria, Rio Grande do Sul, 5596200190, Brazil

Location

Related Publications (21)

  • Machado AF, Almeida AC, Micheletti JK, Vanderlei FM, Tribst MF, Netto Junior J, Pastre CM. Dosages of cold-water immersion post exercise on functional and clinical responses: a randomized controlled trial. Scand J Med Sci Sports. 2017 Nov;27(11):1356-1363. doi: 10.1111/sms.12734. Epub 2016 Jul 19.

    PMID: 27430594BACKGROUND
  • Latorre Roman PA, Villar Macias FJ, Garcia Pinillos F. Effects of a contrast training programme on jumping, sprinting and agility performance of prepubertal basketball players. J Sports Sci. 2018 Apr;36(7):802-808. doi: 10.1080/02640414.2017.1340662. Epub 2017 Jun 21.

    PMID: 28636435BACKGROUND
  • Tveter AT, Dagfinrud H, Moseng T, Holm I. Health-related physical fitness measures: reference values and reference equations for use in clinical practice. Arch Phys Med Rehabil. 2014 Jul;95(7):1366-73. doi: 10.1016/j.apmr.2014.02.016. Epub 2014 Mar 5.

    PMID: 24607837BACKGROUND
  • Mika A, Oleksy L, Kielnar R, Wodka-Natkaniec E, Twardowska M, Kaminski K, Malek Z. Comparison of Two Different Modes of Active Recovery on Muscles Performance after Fatiguing Exercise in Mountain Canoeist and Football Players. PLoS One. 2016 Oct 5;11(10):e0164216. doi: 10.1371/journal.pone.0164216. eCollection 2016.

  • Crisafulli A, Orru V, Melis F, Tocco F, Concu A. Hemodynamics during active and passive recovery from a single bout of supramaximal exercise. Eur J Appl Physiol. 2003 Apr;89(2):209-16. doi: 10.1007/s00421-003-0796-4. Epub 2003 Mar 4.

  • Fairchild TJ, Armstrong AA, Rao A, Liu H, Lawrence S, Fournier PA. Glycogen synthesis in muscle fibers during active recovery from intense exercise. Med Sci Sports Exerc. 2003 Apr;35(4):595-602. doi: 10.1249/01.MSS.0000058436.46584.8E.

  • Vanderthommen M, Makrof S, Demoulin C. Comparison of active and electrostimulated recovery strategies after fatiguing exercise. J Sports Sci Med. 2010 Jun 1;9(2):164-9. eCollection 2010.

  • McDermott BP, Casa DJ, Ganio MS, Lopez RM, Yeargin SW, Armstrong LE, Maresh CM. Acute whole-body cooling for exercise-induced hyperthermia: a systematic review. J Athl Train. 2009 Jan-Feb;44(1):84-93. doi: 10.4085/1062-6050-44.1.84.

  • MISSAU, E.; SIGNORI, L. U. Imersão na água fria na resposta inflamatória após exercícios resistidos. Revista Brasileria de Medina do Esporte, v. In submiss, 2017.

    RESULT
  • Pearcey GE, Bradbury-Squires DJ, Kawamoto JE, Drinkwater EJ, Behm DG, Button DC. Foam rolling for delayed-onset muscle soreness and recovery of dynamic performance measures. J Athl Train. 2015 Jan;50(1):5-13. doi: 10.4085/1062-6050-50.1.01. Epub 2014 Nov 21.

  • TEIXEIRA, A. D. O. et al. Inflammatory response after session of resistance exercises in untrained volunteers. Acta Scientiarum. Health Sciences, v. 37, n. 1, p. 31-39, 2014a.

    RESULT
  • TEIXEIRA, A. D. O. et al. The importance of adjustments for changes in plasma volume in the interpretation of hematological and inflmmatory responses after resistance exercise. Journal of Exercise Physiology, v. 17, n. 4, p. 72-83, 2014b.

    RESULT
  • Nellessen AG, Donaria L, Hernandes NA, Pitta F. Analysis of three different equations for predicting quadriceps femoris muscle strength in patients with COPD. J Bras Pneumol. 2015 Jul-Aug;41(4):305-12. doi: 10.1590/S1806-37132015000004515.

  • Foster C, Florhaug JA, Franklin J, Gottschall L, Hrovatin LA, Parker S, Doleshal P, Dodge C. A new approach to monitoring exercise training. J Strength Cond Res. 2001 Feb;15(1):109-15.

  • Chisholm MD, Birmingham TB, Brown J, Macdermid J, Chesworth BM. Reliability and validity of a weight-bearing measure of ankle dorsiflexion range of motion. Physiother Can. 2012 Fall;64(4):347-55. doi: 10.3138/ptc.2011-41.

  • Bolgla LA, Keskula DR. Reliability of lower extremity functional performance tests. J Orthop Sports Phys Ther. 1997 Sep;26(3):138-42. doi: 10.2519/jospt.1997.26.3.138.

  • SIGNORI, L. U. et al. Efeito de agentes térmicos aplicados previamente a um programa de alongamentos na flexibilidade dos músculos isquiotibiais encurtados. Revista Brasileira de Medicina do Esporte, v. 14, n. 4, p. 328-331, 2008.

    RESULT
  • Giles D, Draper N, Neil W. Validity of the Polar V800 heart rate monitor to measure RR intervals at rest. Eur J Appl Physiol. 2016 Mar;116(3):563-71. doi: 10.1007/s00421-015-3303-9. Epub 2015 Dec 26.

  • NARDI, A. T. DE et al. Different frequencies of transcutaneous electrical nerve stimulation on sympatho-vagal balance. Acta Scientiarum. Health Sciences, v. 39, n. 1, p. 9, 2017.

    RESULT
  • Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

  • Arbiza BCC, da Silva AMV, de Lima KS, Rubin Neto LJ, Nunes GS, Jaenisch RB, Puntel GO, Signori LU. Effect of foam rolling recovery on pain and physical capacity after resistance exercises: A randomized crossover trial. J Bodyw Mov Ther. 2024 Jan;37:226-232. doi: 10.1016/j.jbmt.2023.11.022. Epub 2023 Nov 19.

MeSH Terms

Interventions

ExerciseImmersionCryotherapy

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaInvestigative TechniquesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluators will be blind to interventions.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The four interventions will be randomized.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of the Postgraduate Program in Functional Rehabilitation

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 17, 2019

Study Start

June 1, 2019

Primary Completion

December 31, 2020

Study Completion

April 30, 2021

Last Updated

May 4, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

After publication of the results, the data will be made available to any researcher who requests via email.

Locations