NCT03057210

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

January 30, 2017

Last Update Submit

June 3, 2018

Conditions

Keywords

ExerciseMassagePost-exercise recoveryAthletic performance

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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)

  • Psychological questionnaire

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

  • Belief Questionnaire

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

  • Blood lactate concentration - [Lac]

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

  • Subjective pain assessment

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

  • Perceived recovery

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

Study Arms (5)

S1 (Basal)

NO INTERVENTION

The 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)

EXPERIMENTAL

The 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.

Other: Massage Protocol

S3 (Exercise)

EXPERIMENTAL

The 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.

Other: Stress Protocol

S4 (Exercise + Immediate Massage)

EXPERIMENTAL

In 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.

Other: Stress ProtocolOther: Massage Protocol

• S5 (Exercise + Active Recovery + Delayed Massage)

EXPERIMENTAL

In 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.

Other: Stress ProtocolOther: Massage Protocol

Interventions

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.

S3 (Exercise)S4 (Exercise + Immediate Massage)• S5 (Exercise + Active Recovery + Delayed Massage)

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.

S2 (Massage)S4 (Exercise + Immediate Massage)• S5 (Exercise + Active Recovery + Delayed Massage)

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malu Dos Santos Siqueira

Presidente Prudente, São Paulo, 19015650, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 20, 2017

Study Start

April 3, 2017

Primary Completion

August 18, 2017

Study Completion

August 18, 2017

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations