NCT03386019

Brief Summary

Background: Lower extremity edema is often seen after exercise in healthy individuals, especially sprinters, in sports physical therapy practice. Edema is defined as the excessive fluid accumulation in the interstitial space. Recent studies showed that there could be an increase in fluid up to 31.2 ml after a 15-minute running bout in healthy individuals. Fluid accumulation may be resulted from (1) high intensity training, (2) compression of blood and lymph vessels due to increased soft tissue tension and (3) the effect of gravity. Lower extremity edema not only causes great impact on athlete's recovery and performance, it could also lead to fibrosis, dysfunction and contracture. The pilot study showed that lower extremity edema not only existed post-exercise, and decreased ankle circumference was found after a 5-minute massage session, not only when compared to the status after exercise, but also when compared to the baseline (resting). The result also showed lower extremity edema may exist both during resting and after exercise. However, no studies to date investigated the solutions to decrease lower extremity edema during resting and after exercise in sprinters. Massage has been proven beneficial to athletes by increasing range of motion, promote recovery and increase skin blood flow, however, no study investigated the effect of massage on lower extremity edema and compared that to different common recovery modalities such as cold water immersion and static-stretching. Purposes: To explore the effects of massage on sprinter's gastrocnemius after running on edema and strength with immediate and short-term follow ups. Methods: This study will recruit both male and female sprinters age between 20-30 years old who participate in the event of 100, 200 and 400 meter sprints. After individuals' enrollments and baseline data collections, all subjects will receive all three different treatments (massage, cold water immersion and static stretching) in randomized orders a week apart, respectively. Outcome measures are: visual analogue scale (VAS) score, lower leg volume, pressure pain threshold and horizontal jump distance. All measurements will be recorded at baseline, immediately after exercise, immediately after treatment, and 10 minutes after treatment as the follow up. Descriptive statistics will be used for participants' characteristics. Three-way ANOVA (3 treatments x 4 times x 2 legs) with repeated measures design will be used to detect differences, and post-hoc analysis will be used when interactions are identified. p value of \< .05 will be used in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 6, 2017

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
Last Updated

December 29, 2017

Status Verified

October 1, 2017

Enrollment Period

22 days

First QC Date

December 15, 2017

Last Update Submit

December 20, 2017

Conditions

Keywords

lymphatic massagestatic stretchingcold water immersion

Outcome Measures

Primary Outcomes (1)

  • Lower leg volume

    Lower leg volume was measured with water displacement method using volumeter. First, the volumeter was filled with water until it overflowed into the pitcher under the spout. Before each measurement, the pitcher was emptied, dried and placed back under the spout. The height of the chair was adjusted to ensure that the lower leg was completed immersed into water (the level of the water reached the mark). The pitcher filled with water collected from the volumeter was then weighed so that the volume of the lower leg could be quantified. Since the density of water was close to 1, the weight of the outflowed water was equal to the volume of the lower leg. To ensure that the assessor could measure the same site at all time periods, the same mark was used in each testing session.

    change from baseline to 10 minutes after treatment

Secondary Outcomes (3)

  • Pressure pain threshold

    change from baseline to 10 minutes after treatment

  • Perception of discomfort

    change from baseline to 10 minutes after treatment

  • Horizontal jump distance

    change from baseline to 10 minutes after treatment

Study Arms (1)

Sprinters

EXPERIMENTAL

Sprinters will be recruited from the track and field team of National Taiwan Normal University (NTNU) in this study. After individuals' enrollments and baseline data collections, all subjects will receive all three different treatments (massage, cold water immersion and static stretching) in randomized orders a week apart, respectively. Outcome measures are: visual analogue scale (VAS) score, lower leg volume, pressure pain threshold and horizontal jump distance. All measurements will be recorded at baseline, immediately after exercise, immediately after treatment, and 10 minutes after treatment as the follow up.

Other: Lymphatic massageOther: Static stretchingOther: Cold water immersion

Interventions

One certified physical therapist will perform the massage regimens and techniques adapting from Swedish massage such as effleurage and petrissage that will be used in the massage group. Participants will first lay down in prone position, and the massage leg will be supported on the therapist's leg or on pillows with legs being positioned at approximately 30 degrees of knee flexion. This can promote venous return of the lower legs and also keep the ankle plantar flexors in a relative low muscle tension position. After positioning, long strokes will be applied from the distal to proximal part of gastrocnemius with approximately 20 repetitions and then 20 repetitions of circular strokes would be applied at the popliteal fossa. Finally, therapist will knead around participant's Achilles tendon for 10 repetitions.6 The combination of the techniques mentioned above will repeat 3 times in each subject, and the total duration of massage will be approximately 5 minutes.

Sprinters

For the static stretching group, participants will perform the standing gastrocnemius stretches. First, participant stands facing a wall and put the stretched leg behind the body. Physical therapist will ask the participant to slightly flex the front leg, and keep back leg extended with heel on the ground. Both toes will be positioned pointing forward. Participant will then be asked to lunge forward slowly until the calf muscles on the back leg feeling stretched. Participant will hold in this position for 60 seconds and repeat 3 times.

Sprinters

In the cold-water immersion group, participant's lower leg will be put in a bucket filled with cold water for 10 minute. The temperature of the water will be kept in 11-15 degrees Celsius.52 The water level should reach participant's fibular head to ensure complete immersion of the lower leg.

Sprinters

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years-old of age.
  • Sprinters participate in 100-meter, 200-meter or 400-meter sprint events.
  • Trainings at least 5 days per week and at least 2 hours per day.

You may not qualify if:

  • Lymphedema
  • Peripheral arterial disease
  • Chronic venous disease
  • Musculoskeletal injuries of the testing leg in recent 3 months (that would influence practice schedule)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, Taiwan

Location

MeSH Terms

Interventions

Manual Lymphatic DrainageMuscle Stretching Exercises

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: There will be a total of 4 different time points where outcome measures will be assessed including: baseline, immediately after pre-conditioning, immediately after treatment and 10 minutes after treatment. Once the participant completed the assessment of one treatment, another assessment session from one of the two remaining treatments will be scheduled in the following week, and the data collections for all three treatments will be finished in three consecutive weeks. This could ensure that all participants receive similar training schedules with similar training intensity within a fixed time period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2017

First Posted

December 29, 2017

Study Start

November 6, 2017

Primary Completion

November 28, 2017

Study Completion

December 1, 2017

Last Updated

December 29, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations