MassageNCT04201977

Comparison of Different Forms of Recovery on the Functionality After Physical Exercise

A study testing Foam Roller Recovery, Active recovery and Immersion in cold water in people with Massage and Inflammatory Response, run by Universidade Federal de Santa Maria at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Massage, Inflammatory Response, Muscle, Skeletal
What is being tested?: Foam Roller Recovery, Active recovery and Immersion in cold water
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteBrazil
Study dates: 1 Jun 2019to 30 Apr 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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:

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Luis Ulisses Signori
Santa Maria, Rio Grande do Sul, 5596200190

Other trials in Brazil

About this study

Official title: Comparison of Different Forms of Recovery on the Functionality After Physical Exercise: Randomized Clinical Trial

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.

Read the detailed description

The volunteers included in the study will perform an evaluation to verify the eligibility criteria, physical evaluation (weight, height, systemic blood pressure) and functional capacity to determine the exercise parameters. After will be presented to the four interventions, ie the recovery techniques after the exercises favoring their adaptation. There will be four resistance exercise sessions followed by interventions with a one week interval between each session. Interventions (passive recovery = 1, active recovery = 2, recovery with IAF = 3 and recovery with myofascial self-release = 4) will be randomized. Functionality assessments will be performed before and one hour after the intervention protocol. DOMS will be evaluated 24 and 72 hours after the exercise protocol. Evaluators will be blind to interventions.

Conditions: Massage, Inflammatory Response, Muscle, Skeletal, Cryotherapy Effect, Functional Disturbance
Being tested: Foam Roller Recovery, Active recovery, Immersion in cold water, Passive recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Foam Roller RecoveryOther
Also called Self-massage, Foam Roller
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).
Active recoveryOther
Also called Exercise
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)
Immersion in cold waterOther
Also called Cryotherapy
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).
Passive recoveryOther
Also called Control
Volunteers will be seated for 20 min after the resistance exercise session (TEIXEIRA et al., 2014a, 2014b).

Study groups in NCT04201977
Study group	Role	What they receive
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). Receives: 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); Receives: 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). Receives: 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). Receives: Other: Foam Roller Recovery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 minutes after the interventions

Secondary outcomes (9)

Subjective exertion perception
Subjective exertion perception ny the Borg scale (FOSTER et al. 2001). The scale ranges from 0 (no pain) to 10 (maximum bearable pain). Data will be presented in points average.
Measured: 30 minutes after the interventions
Flexibility
The flexibility will be assessed by the Bank of Wells and Dilon (SIGNORI et al., 2008) and Lunge Test (CHISHOLM et al. 2012). Data will be presented in centimeter (cm).
Measured: 30 minutes after the interventions
Muscle power
Muscle power will be assessed by single-limb general function (Single Hop Test) (BOLGLA; KESKULA, 1997). Data will be presented in centimeter (cm).
Measured: 30 minutes after the interventions
Agility
Agility will be assessed by t-test (LATORRE ROMÁN ; VILLAR MACIAS; GARCÍA PINILLOS, 2017). Data will be presented in seconds (s)
Measured: 30 minutes after the interventions
Speed
Speed will be evaluated by 30-meter test (PEARCEY et al., 2015). Data will be presented in seconds (s).
Measured: 30 minutes after the interventions
Muscle endurance
Muscle fatigue strength will be assessed by the sit-up test (TVETER et al., 2014). Data will be presented by the number of repetitions.
Measured: 30 minutes after the interventions
Systemic blood pressure
Blood pressure (BP) monitoring (Systolic blood pressure - SBP, Diastolic Blood Pressure - DBP and Mean Blood Pressure - MBP) will be performed using a multiparametric monitor (Dixtal, model 2021, Manaus, Brazil). The cuff will be positioned on the right arm with the patient positioned in the supine position on the stretcher. Data will be presented in mmHg.
Measured: 60 minutes after the interventions
Heart rate variability
Heart rate variability (HRV) will be assessed before exercise and after interventions. The autonomic balance will be evaluated by the HRV, for the acquisition of the signal will be used a Polar frequency pulse model 810i (GAMELIN; BERTHOTOIN; BOSQUET, 2016). The acquisition of the electromyographic signal (ECG sampling rate - 1 kHz) of the RR interval time series will be acquired by continuous interval and will occur before and immediately after the interventions. For data collection the volunteer will remain lying supine at rest for 10 minutes and after standing for the same period of time, after the procedure will be repeated with breath control (16 movements per minute; I / E: 2 / 3) (NARDI et al., 2017). The analysis will be done by spectral power density (European Society of Cardiology \& The North American Society of Pacing and Electrophysiology, 1996). Data will be presented absolute units (ms2) and your normalized units (n.u.).
Measured: 60 minutes after the interventions
Delayed onset muscle soreness
Delayed onset muscle soreness (DOMS) will be evaluated by visual analog scale (EVA). The scale ranges from 0 (no pain) to 10 (maximum bearable pain).
Measured: DOMS will be evaluated 24, 48 and 72 hours after the exercise protocol.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201930 Apr 2021

First posted17 Dec 2019
Study start1 Jun 2019
Primary completion31 Dec 2020
Study completion30 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for MassageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: The four interventions will be randomized.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04201977
Sponsor's protocol ID: nº 047670
Status last verified: Apr 2021
First submitted: 10 Dec 2019
Last updated: 4 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: After publication of the results, the data will be made available to any researcher who requests via email.

Publications

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.
PubMed 27430594
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.
PubMed 28636435
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.
PubMed 24607837
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.
PubMed 27706260
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.
PubMed 12665987
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.
PubMed 12673142
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.
PubMed 24149681
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.
PubMed 19180223
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.
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.
PubMed 25415413
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.
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.
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.
PubMed 26398750
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.
PubMed 11708692
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.
PubMed 23997389

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Different Forms of Recovery on the Functionality After Physical Exercise: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04201977
Acronym / sponsor ID: nº 047670
Conditions: Massage, Inflammatory Response, Muscle, Skeletal, Cryotherapy Effect, Functional Disturbance
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Universidade Federal de Santa MariaUniversity, hospital or other
Study start: 1 Jun 2019 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 17 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: The four interventions will be randomized.

Arm	Type	Receives
Exercise session followed passive recovery	Active comparator	Other: Passive recoveryPrior 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).
Exercise session followed active recovery	Active comparator	Other: Active recoveryThe 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);
Exercise session followed immersion in cold water recovery	Active comparator	Other: Immersion in cold waterThe 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).
Exercise session followed foam roller recovery	Active comparator	Other: Foam Roller RecoveryThe 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).

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male,
Literate,
Normotensive volunteers,
Aged minimum18 to maximum 35 years old,
Physically active (IPAQ scale).

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Foam Roller RecoveryAlso: Self-massage, Foam RollerMyofascial 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).	Other	Exercise session followed foam roller recovery
Active recoveryAlso: ExerciseActive 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)	Other	Exercise session followed active recovery
Immersion in cold waterAlso: CryotherapyImmersion 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).	Other	Exercise session followed immersion in cold water recovery
Passive recoveryAlso: ControlVolunteers will be seated for 20 min after the resistance exercise session (TEIXEIRA et al., 2014a, 2014b).	Other	Exercise session followed passive recovery

Primary outcome

Isometric peak torque
Time frame: 30 minutes after the interventions
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.

9 secondary outcomes

Subjective exertion perception
Time frame: 30 minutes after the interventions
Flexibility
Time frame: 30 minutes after the interventions
Muscle power
Time frame: 30 minutes after the interventions
Agility
Time frame: 30 minutes after the interventions
Speed
Time frame: 30 minutes after the interventions
Muscle endurance
Time frame: 30 minutes after the interventions
Systemic blood pressure
Time frame: 60 minutes after the interventions
Heart rate variability
Time frame: 60 minutes after the interventions
Delayed onset muscle soreness
Time frame: DOMS will be evaluated 24, 48 and 72 hours after the exercise protocol.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
Background: PubMed 27430594Machado 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.
Background: PubMed 28636435Latorre 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.
Background: PubMed 24607837Tveter 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.
Results publication: PubMed 27706260Mika 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.
Results publication: PubMed 12665987Crisafulli 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.
Results publication: PubMed 12673142Fairchild 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.
Results publication: PubMed 24149681Vanderthommen 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.
Results publication: PubMed 19180223McDermott 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.
Results publicationMISSAU, E.; SIGNORI, L. U. Imersão na água fria na resposta inflamatória após exercícios resistidos. Revista Brasileria de Medina do Esporte, v. In submiss, 2017.
Results publication: PubMed 25415413Pearcey 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.
Results publicationTEIXEIRA, 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.
Results publicationTEIXEIRA, 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.
Individual participant dataSharing planned: No. After publication of the results, the data will be made available to any researcher who requests via email.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Foam Roller Recovery, Active recovery and Immersion in cold water in people with Massage and Inflammatory Response, run by Universidade Federal de Santa Maria at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Isometric peak torque (time frame: 30 minutes after the interventions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04201977, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.