RunningNCT03578666
Massage Versus Cold Water Immersion for Fatigue-induced Biomechanical Alterations
A study testing Massage and Cold water immersion in people with Running and Fatigue, run by Iraia Bidaurrazaga-Letona.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- What is being tested?
- Massage and Cold water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Jul 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally active (current participation in races and a 10-km race time<34.5-min)
Who cannot join
- Suffered from any injury within the preceding 4 months.
About this study
Official title: 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.
Read the 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).
- Being tested
- Massage, Cold water immersion
- Keywords
- recovery intervention, fatigue, running, cryotherapy, running economy
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
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.
Cold water immersionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Massage Group | Experimental | Recreational active runners recruited from local running clubs (n= 16) will receive 40 minutes of massage therapy. Receives: Other: Massage |
| Cold water immersion group | Experimental | Recreational active runners recruited from local running clubs(n= 16) will immerse for 10 minutes in a cold water bath Receives: Other: Cold water immersion |
| Control group | No intervention | Recreational active runners recruited from local running clubs will rest passively in a sitting position for 30-min period |
What is being measured
The primary outcome is the main question the study is designed to answer.
- CHANGE FROM BASELINE OXYGEN UPTAKE 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).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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."
Measured: Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
Secondary outcomes (3)
Body height (cm)
- 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.
Measured: Participants will be assessed at baseline (24 hours after an exhaustive training session).
Body mass (kg)
- 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.
Measured: Participants will be assessed at baseline (24 hours after an exhaustive training session).
- Skinfolds (mm)
- 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.
Measured: Participants will be assessed at baseline (24 hours after an exhaustive training session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Mar 2016
- Primary completion30 Jun 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RunningStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iraia Bidaurrazaga-Letona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iraia Bidaurrazaga-Letona, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578666
- Sponsor's protocol ID
- IT811-13
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunabeitia I, Arrieta H, Rodriguez-Larrad A, Gil J, Esain I, Gil SM, Irazusta J, Bidaurrazaga-Letona I. Effects of Massage and Cold Water Immersion After an Exhaustive Run on Running Economy and Biomechanics: A Randomized Controlled Trial. J Strength Cond Res. 2022 Jan 1;36(1):149-155. doi: 10.1519/JSC.0000000000003395.
PubMed 31800477
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage and Cold Water Immersion After Exhausting Exercise on Biomechanical Parameters and Running Economy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03578666
- Acronym / sponsor ID
- IT811-13
- Keywords
- recovery intervention, fatigue, running, cryotherapy, running economy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Iraia Bidaurrazaga-LetonaUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 6 Jul 2018 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage Group | Experimental | Other: MassageRecreational active runners recruited from local running clubs (n= 16) will receive 40 minutes of massage therapy. |
| Cold water immersion group | Experimental | Other: Cold water immersionRecreational active runners recruited from local running clubs(n= 16) will immerse for 10 minutes in a cold water bath |
| Control group | No intervention | –Recreational active runners recruited from local running clubs will rest passively in a sitting position for 30-min period |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recreationally active (current participation in races and a 10-km race time<34.5-min)
Key exclusion criteria (1 listed)
- Suffered from any injury within the preceding 4 months.
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 |
|---|---|---|
| MassageThe 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. | Other | Massage Group |
| Cold water immersionThe 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. | Other | Cold water immersion group |
Primary outcome
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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."
3 secondary outcomes
Body height (cm)
Time frame: 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).
- Skinfolds (mm)
Time frame: Participants will be assessed at baseline (24 hours after an exhaustive training session).
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 9 Jul 2018.
- Derived from this study: PubMed 31800477Dunabeitia I, Arrieta H, Rodriguez-Larrad A, Gil J, Esain I, Gil SM, Irazusta J, Bidaurrazaga-Letona I. Effects of Massage and Cold Water Immersion After an Exhaustive Run on Running Economy and Biomechanics: A Randomized Controlled Trial. J Strength Cond Res. 2022 Jan 1;36(1):149-155. doi: 10.1519/JSC.0000000000003395.
- Individual participant dataSharing planned: No
Related trials for Running
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Active, not recruitingPhase 3
Study to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS Symptoms
Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation
Enrolling by invitation
An Exercise-based Rehabilitation Program for a Recreational Long-distance Runner With Long-standing Groin Pain
Groin Pain
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
Not yet recruitingPhase 2
The METAMAX Study: MT027 Allogeneic CAR-T for Brain Metastases From Advanced Solid Tumors
Brain Metastases From Solid Tumors
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.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and Cold water immersion in people with Running and Fatigue, run by Iraia Bidaurrazaga-Letona.
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 1 inclusion and 1 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 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
- 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.). The study lists 8 primary outcomes in all. 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 NCT03578666, which also lists 1 linked publication.
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 9 Jul 2018.