Massage Versus Cold Water Immersion for Fatigue-induced Biomechanical Alterations

July 6, 2018 updated by: Iraia Bidaurrazaga-Letona

Effects of Massage and Cold Water Immersion After Exhausting Exercise on Biomechanical Parameters and Running Economy: A Randomized Controlled Trial

The optimization of recovery to alleviate the effects of fatigue in athletes can provide valuable performance advantage. However, despite the growing body of literature regarding effects of different interventions in fatigue, there is still lack of clarity regarding the efficacy of interventions on running economy and, particularly, fatigue-induced biomechanical alterations. Therefore, the aim of this study was to compare the effects of massage and cold water immersion for enhancing recovery and alleviating fatigue after an exhausting training session. We hypothesized that both massage and cold water immersion would enhance biomechanical parameters compared with a control condition and hence would improve subsequent running economy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this randomized controlled all the subjects (n=48) will performed the same protocol. The protocol will begin with a exhausting training session (20-min warm-up consisted of 15-min of continuous self-paced running followed by 5-min of fast-finish progression runs increasing speeds (from approximately 60% to 80% of maximal heart rate, participant controlled), 10 x 500 m sprints at 90% of maximal heart rate with a 2-min rest period between bouts and a recovery phase consisting of 10-min of slow jogging). Twenty-four hours after this exhausting training, subjects will perform an incremental running test on a treadmill (Pre-intervention test) where subjects will start at 12 km/h for 6 min after which speed will be increased by 2 km/h every 6 min until a 16 km/h trial is completed. At the end of each stage, participants will rate their perceived exertion using the 10-point Modified Borg rating of perceived exertion scale (RPE scale). One hour after this test, in one protocol subjects will receive the massage intervention, (Massage group); other group will receive a cold water immersion intervention (Cold water immersion group); in the other group (Control group) participants will rest passively in a sitting position for 30-min period. To evaluate the relevance of the changes induced by the interventions (massage, cold water immersion, passive rest) subjects will repeat the treadmill test 48 hours after the first test (72 hours after the exhaustive training).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Recreationally active (current participation in races and a 10-km race time<34.5-min)

Exclusion Criteria:

  • Suffered from any injury within the preceding 4 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Massage Group
Recreational active runners recruited from local running clubs (n= 16) will receive 40 minutes of massage therapy.
Other: Massage
The intervention will be applied to both legs to a constant distal to proximal stroking rhythm. Firstly, participants will be lying in a prone position for 22 min: 1 min on the sole of the foot, 1 min on the Achilles tendon, 1 min on the soleus muscle, 3 min on the triceps muscle, 4 min on the hamstring muscles, 30 s tapotement from the sole of the foot to the hamstrings and 30 s superficial effleurage from the sole of the foot to the hamstrings. Then they will assume a supine position for 18 min: 1 min on the sole of the foot, 3 min on the tibialis anterior and peroneus lateralis muscles and 4 min in the quadriceps, adductors and lata muscles, 30 s tapotement from the sole of the foot to the hamstrings and 30 s superficial effleurage from the sole of the foot to the hamstrings.
Experimental: Cold water immersion group
Recreational active runners recruited from local running clubs(n= 16) will immerse for 10 minutes in a cold water bath
Other: Cold water immersion
The cold water immersion group immersed their lower limbs (ensuring that the iliac crests were fully immersed) in an ice bath filled with cooled water for 10 min. The water was maintained at a mean temperature of 10 degrees (±0.5°) by the addition of ice.
No Intervention: Control group
Recreational active runners recruited from local running clubs will rest passively in a sitting position for 30-min period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
- CHANGE FROM BASELINE OXYGEN UPTAKE AT 48 HOURS AFTER THE TREATMENT
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
Oxygen uptake (mL kg-1 min-1) will be assessed in an incremental running test on a treadmill (HP Cosmos pulsar, Nussdorf-Traunstein, Germany). Oxygen uptake will be recorded using a gas analyzer system (Esgostik Geratherm, Geschwenda, Germany).
Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
- CHANGE FROM BASELINE STRIDE LENGTH AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
Stride length (cm) defined as the length the treadmill belt moves from toe-off to initial ground contact in successive steps, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.
Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
- CHANGE FROM BASELINE STRIDE FREQUENCY AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
Stride frequency, defined as the number of ground contact events per minute, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
- CHANGE FROM BASELINE STRIDE ANGLE AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
Stride angle (º), defined as the angle of the parable tangent derived from the theoretical arc traced by a foot during a stride and the ground, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
- CHANGE FROM BASELINE GROUND CONTACT TIME AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
Ground contact time (s), defined as the time from when the foot contacts the ground to when the toes left the ground and was determined by the disruption of the infrared gates, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
- CHANGE FROM BASELINE SWING TIME AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
The swing time (ms) corresponds to the time from foot flat to initial take-off. Swing time will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.
Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
- CHANGE FROM BASELINE CONTACT PHASE AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
Contact time (ms), defined as the percentage of the ground contact time at which the different sub-phases of stance phase occur, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.
Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
- CHANGE FROM BASELINE RATING OF PERCEIVED EXERTION AT 48 HOURS AFTER THE TREATMENT
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
Modified Borg rating of perceived exertion scale (RPE scale) defined as a way of measuring physical activity intensity level, how hard you feel like your body is working. The Borg RPE scale is a numerical scale that ranges from 1 to 10, where 0 means "no exertion at all" and 10 means "maximal exertion."
Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body height (cm)
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session).
- Body height (cm) will be measured using a stadiometer (Año Sayol, Barcelona, Spain) following the guidelines outlined by the International Society for the Advancement of Kinanthropometry.
Participants will be assessed at baseline (24 hours after an exhaustive training session).
Body mass (kg)
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session).
- Body mass (kg) will be measured using a balance (Año Sayol, Barcelona, Spain) following the guidelines outlined by the International Society for the Advancement of Kinanthropometry.
Participants will be assessed at baseline (24 hours after an exhaustive training session).
- Skinfolds (mm)
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session).
- Skinfolds (mm) will be measured at four sites (triceps, subscapular, abdominal, suprailiac) using a Harpenden Skinfold Caliper (Baty, West Sussex, UK) following the guidelines outlined by the International Society for the Advancement of Kinanthropometry.
Participants will be assessed at baseline (24 hours after an exhaustive training session).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iraia Bidaurrazaga-Letona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IT811-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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