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Healthy VolunteersNCT03057210

Effects of Massage on the Short-term Post-exercise Recovery

A study testing Stress Protocol and Massage Protocol in people with Healthy Volunteers, run by São Paulo State University 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

Objectives: To analyze the behavior of the effects of massage on clinical, metabolic and functional variables in different scenarios: i) under no stress or massage application; ii) after massage; iii) after exhaustion protocol; iv) after the immediate application of post-exercise massage; v) after application of the… Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Stress Protocol and Massage Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteBrazil
Study dates
3 Apr 2017to 18 Aug 2017
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 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy (self-report)
  • Male gender;
  • Aged between 18-30 years;

Who cannot join

  • Presence of anemia, inflammation, or diabetes;
  • History of muscle injury in the lower limbs or trunk in the previous six months;

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Malu Dos Santos Siqueira

    Presidente Prudente, São Paulo, 19015650

Other trials in Brazil

About this study

Official title: Effects of Massage on the Short-term Post-exercise Recovery on Functional, Clinical and Metabolic Outcomes

Objectives: To analyze the behavior of the effects of massage on clinical, metabolic and functional variables in different scenarios: i) under no stress or massage application; ii) after massage; iii) after exhaustion protocol; iv) after the immediate application of post-exercise massage; v) after application of the massage 1hour post-exercise.

Method: This was a randomized cross-over clinical trial in which 24 participants had their clinical, functional and metabolic outcome data analyzed under different scenarios: i) control scenario (CO): basal condition (under no stress or massage application); ii) Massage (MA): after receiving the massage; iii) Exhaustion protocol (PE): after protocol of exhaustion; iv) PE + immediate massage (EMI): after the protocol of exhaustion followed immediately by massage; iv) PE + delayed massage (EMT): after the protocol of exhaustion and massage received 1h after its end. The exhaustion protocol used consisted of 10 series of 10 jumps and one Wingate test and the manual massage protocol was composed of 12 minutes of massage, 3 minutes for the anterior region of the thigh of each lower limb and 6 minutes to the dorsal trunk. The variables studied were: muscle soreness, perceived recovery, maximal voluntary isometric contraction (MVIC), strength and power in the guided bar, vertical jump and blood lactate concentration [Lac].

Measurements. The primary outcome measures will be measured 2h after the start of each stage, and the secondary outcome measures will be measured at specific times during each stage. The primary outcome includes measures of functional performance, and the measures of secondary outcome includes clinical and metabolic variables.

Read the detailed description

Introduction: Background: Massage has been shown over the years a recuperative technique widely used in sports. Studies demonstrate divergent results of the technique in terms of recovery of functional, clinical and metabolic performance after exercise. The wide methodological variety of these studies, as in relation to the moment of massage application, may be a possible justification for such a scenario. Thus, the study investigating the effects of massage applied at different moments of post-exercise recovery deserves to be highlighted.

Objectives: To analyze the behavior of the effects of massage on clinical, metabolic and functional variables in different scenarios: i) under no stress or massage application; ii) after massage; iii) after exhaustion protocol; iv) after the immediate application of post-exercise massage; v) after application of the massage 1hour post-exercise.

Design: A cross-over randomized clinical trial.

Method: This was a randomized cross-over clinical trial in which 24 participants had their clinical, functional and metabolic outcome data analyzed under different scenarios: i) control scenario (CO): basal condition (under no stress or massage application); ii) Massage (MA): after receiving the massage; iii) Exhaustion protocol (PE): after protocol of exhaustion; iv) PE + immediate massage (EMI): after the protocol of exhaustion followed immediately by massage; iv) PE + delayed massage (EMT): after the protocol of exhaustion and massage received 1h after its end. Exhaustion protocol: consisted of 10 series of 10 jumps and one Wingate test. Manual massage protocol: was composed of 12 minutes of massage, 3 minutes for the anterior region of the thigh of each lower limb and 6 minutes to the dorsal trunk.

Measurements. The primary outcome measures will be measured 2h after the start of each stage, and the secondary outcome measures will be measured at specific times during each stage. The primary measures includes the Strength and power test, Maximal voluntary isometric contraction (MVIC) and Squat jump. The secondary measures includes the subjective pain assessment, perception of recovery, psychological questionnaire, belief questionnaire and de analysis blood lactate concentration.

The variables studied were: muscle soreness, perceived recovery, maximal voluntary isometric contraction (MVIC), strength and power in the guided bar, vertical jump and blood lactate concentration [Lac].

Analysis: The normality of the data will be evaluated through the Shapiro-Wilk test. The sphericity of the data was tested by the Mauchly's test. In case of breach of the sphericity assumption, Greenhouse-Geisser corrections were used. Effect size was calculated using partial eta-square (η²) and interpreted as small (≥0.01), moderate (≥0.06) or large (≥0.14). When identified a large effect size, was used the Friedman's test with post-hoc Bonferroni test, for soreness and perceived recovery, and Repeated Measures ANOVA with post-hoc Tukey's test for vertical jump and MVIC. The level of significance was set at 5%.

Being tested
Stress Protocol, Massage Protocol
Keywords
Exercise, Massage, Post-exercise recovery, Athletic performance
Medical subject headings
Motor Activity

What participants receive

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

  • Stress ProtocolOther

    Participants will be submitted to an exercise protocol consisting of a jumping program and a maximum short cycle test (ALMEIDAetal). The jumping program consists of 10 sets of 10 jumps with one minute interval between sets. The participants will then perform the Wingate Anaerobic Test protocol, which will be performed on a Biotec 2100 cycle ergometer (Cefise, Nova Odessa, Brazil). A 5-minute warm-up will be carried out where the participant will pedal at a speed of 60 to 90 rpm with a fixed load of 1.0 kg and perform sprints in the 2nd and 4th minute and the test itself, which consists of a maximum of pedals In 30 seconds with a stipulated load of 0.075 kP · kg-1 of the participant's body mass.

  • Massage ProtocolOther

    the present protocol will have a total of 12 minutes duration, being six minutes in the anterior region of the thigh (three minutes for each limb) and six minutes in the posterior region of the trunk.

    Surface and deep sliding techniques will be used, the latter being presented in two intensities, moderate or intense, gradually increased. The massage will be performed towards the muscle fibers, from distal to proximal and following the lymphatic flow. In addition to the standardization of the intensity of the massage performed by the physiotherapist, in order to avoid causing discomfort and possible variations in the application of the technique, participants should report their level of comfort from a scale that considers the technique "light", "moderate" or "Intense", corresponding respectively to surface slip, Deep Slip 1 and Deep Slip 2.

Study groups in NCT03057210
Study groupRoleWhat they receive
S1 (Basal)No interventionThe behavior of the variables of functional and clinical outcome will be analyzed under no stress or recovery technique. In this stage, only the functional tests and the collection of clinical data will be performed.
S2 (Massage)ExperimentalThe behavior of the variables of functional and clinical outcome will be analyzed under stress or recovery technique. In this stage, only the functional tests and the collection of clinical data will be performed.
Receives: Other: Massage Protocol
S3 (Exercise)ExperimentalThe behavior of the variables of functional, clinical and metabolic outcome will be analyzed before the exercise protocol is performed. In this stage the volunteers will first perform the protocol for exhaustion, and in specific moments the blood lactate and clinical data will be collected, and 2h after the beginning of the exercise protocol, the functional tests will be performed.
Receives: Other: Stress Protocol
S4 (Exercise + Immediate Massage)ExperimentalIn this stage, the behavior of the variables of functional, clinical and metabolic outcome will be analyzed from the exercise protocol, followed by massage. Firstly the volunteers will carry out the protocol for exhaustion and the massage application will be done immediately after the end of the exercise. Blood lactate and clinical data will be collected at specific times during this stage. After 2h of the beginning of the stress protocol, the functional tests will be performed.
Receives: Other: Stress Protocol; Other: Massage Protocol
• S5 (Exercise + Active Recovery + Delayed Massage)ExperimentalIn this stage, the behavior of the variables of functional, clinical and metabolic outcome will be analyzed before the exhaustion protocol and the application of the massage after 1h of passive recovery. Firstly the volunteers will perform the protocol for exercise, followed by a passive recovery of 1h and then the massage application. The functional tests will be performed 2 hours after the stress protocol begins. Again, blood lactate collection and clinical data will occur at specific times.
Receives: Other: Stress Protocol; Other: Massage Protocol

What is being measured

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

  1. Squat jump

    For the initial positioning of the test, the participant was instructed to remain with the soles of the feet in contact with the jump platform (Multisprint, Hidrofit, Brazil), lower limbs flexed at 90º, hands at waist, trunk erect and without previous movements. Participants were familiarized with the test procedures, and were instructed to perform a maximum jump keeping the knees extended (180º of angulation)(27). Each participant performed three jumps with rest interval of 30 seconds between them and the best measure was adopted.

    Measured: In Stage 1 (Baseline), 2 hours after the intervention in Stage 2, and 2 hours after the stress protocol in Stages 3, 4 and 5.

  2. Maximal voluntary isometric contraction (MVIC)

    Prior to the MVIC assessment, the participants performed a warm-up consisting of 10 repetitions of knee flexion-extension at 180°.s-1 (3.14rad.s-1) throughout all the range of motion(28). Muscle function was determined by the highest torque normalized by participants' body weight (MVIC/weight), obtained through MVIC of the knee extensors of the dominant limb positioned at 60º of knee flexion (with 0º corresponding to the maximum extension) in the isokinetic dynamometer (Biodex System 4 Pro, New York, USA). Participants were instructed and verbally encouraged to perform maximal contractions during the test. There were 2 minutes of rest between the repetitions.

    Measured: In Stage 1 (Baseline), 2 hours after the intervention in Stage 2, and 2 hours after the stress protocol in Stages 3, 4 and 5.

  3. Strength test

    In a vertical squat with a guided bar, the participants performed squats with continuous movement until the thighs reached the horizontal plane, with the trunk as aligned as possible, and immediately performed the opposite movement, returning to the initial position. For the strength test, the heating was composed of 10 repetitions at 40% of the body mass of the participants. The last trunk extension performed without compensations with the highest possible load was determined as 1RM (one-repetition maximum). There were 2 minutes of rest between sets.

    Measured: In Stage 1 (Baseline), 2 hours after the intervention in Stage 2, and 2 hours after the stress protocol in Stages 3, 4 and 5.

  4. Power test

    In a vertical squat with a guided bar, the participants performed squats with continuous movement until the thighs reached the horizontal plane, with the trunk as aligned as possible, and immediately performed the opposite movement, returning to the initial position. The distance performed eccentrically and the concentric velocity of each repetition were recorded by a linear velocity transducer. The eccentric phase was performed at a controlled mean velocity of 0.5 m/s and the concentric phase at maximum velocity (explosively). The warm up was composed of five repetitions with the bar (14 kg) and the test was performed progressively and with increments of 10 kg in each series, with two attempts performed with each load until the participant reached the load closest to his 1RM. There was a 2-minute interval between repetitions. The best attempt with each load was recorded.

    Measured: In Stage 1 (Baseline), 2 hours after the intervention in Stage 2, and 2 hours after the stress protocol in Stages 3, 4 and 5.

Secondary outcomes (5)
  1. Psychological questionnaire

    Participants were invited to fill out a psychological questionnaire that aims to subjectively document physical and mental readiness scores for exercise, fatigue, vigor, drowsiness, and muscle pain. It is important to inform that the intention of the application of this instrument was to provide control data on the general condition of the volunteer at the beginning of each session and not the verification of effects related to the interventions proposed in this trial.

    Thus, participants were instructed to mark a dash on a 10-centimeter visual analog scale between two extremes, zero being "least possible" and 10 indicating "most possible" for each rating.

    Measured: In stages 1 to 5 at the beginning of the session before the interventions

  2. Belief Questionnaire

    Participants were invited to respond to a questionnaire designed to measure beliefs about the effectiveness of the technique they were exposed to. It is an adaptation of the questionnaire used in the study by Moraska et al. (20). In this questionnaire participants were instructed to respond with "Yes", "No" or "I do not know" the following question: "Do you think massage will be beneficial to your recovery after intense exercise?"

    Measured: In stages 1 to 5 at the beginning of the session before the interventions

  3. Blood lactate concentration - [Lac]

    For analysis of blood lactate concentration [Lac], 25 μl of the ear lobe arterialized blood were collected from heparinized capillaries and scrounged in eppendorf-type polyethylene tubes (1.5 mL) containing 50 μl of sodium fluoride (NaF - 1%), for later lactacidemic analysis, performed in a laximeter (YSI, Yellow Springs - 1500, OH, USA). The lactate values were expressed in mmol / L. The lactate curve was analyzed from the absolute plasma lactate values. Blood lactate samples were collected prior to the initiation of the exhaust protocol, and at minutes 2, 5, 8, 11, 14, 30, 60, 90 and 120 after the protocol of physical exhaustion, and therefore comprising at some moments the period of performing the massage.

    Measured: Baseline and at minutes 2, 5, 8, 11, 14, 30, 60, 90 and 120 after the stress protocol in stages 3, 4 and 5.

  4. Subjective pain assessment

    The subjective evaluation of pain was obtained through the Visual Analogue Scale (VAS), graded from 0 to 10, with zero being the total absence of pain and 10 the maximum level of pain supported by the individual. The participants were asked to perform an isometric contraction of the dominant quadriceps muscle, and the subjects were asked about the presence of pain in this limb, identifying by means of the scale the number corresponding to the intensity of pain at the present moment.

    Measured: In Stages 3, 4 and 5: in the minutes 13, 60, 73 and 120 after the stress protocol.

  5. Perceived recovery

    Perceived recovery of lower limbs submitted to PEF was assessed by a 10-point Likert Scale, where 1 indicates "not recovered" and 10 "fully recovered".

    The scale was presented to the participants and so that they were not influenced by the researcher, they answered the following question: "From 1 to 10 points, how do you rate your perception of recovery felt in your lower limbs if you had to do the same exercise protocol at this time? "

    Measured: In Stages 3, 4 and 5: in the minutes 13, 60, 73 and 120 after the stress protocol.

Timeline

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

  1. First posted20 Feb 2017
  2. Study start3 Apr 2017
  3. Primary completion18 Aug 2017
  4. Study completion18 Aug 2017

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03057210
Sponsor's protocol ID
SaoPSU3
Status last verified
Jun 2018
First submitted
30 Jan 2017
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stress Protocol and Massage Protocol in people with Healthy Volunteers, run by São Paulo State University 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 3 inclusion and 2 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 6 Jun 2018. 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?

Squat jump (time frame: In Stage 1 (Baseline), 2 hours after the intervention in Stage 2, and 2 hours after the stress protocol in Stages 3, 4 and 5.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Jun 2018.

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