- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03386019
The Efficacy of Lymphatic Massage on Lower Extremity Edema and Performance After Treadmill Exercise in Sprinter Compare to Static Stretching and Cold Water Immersion
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei, Taiwan
- School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 20-30 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.
Exclusion criteria:
- Lymphedema
- Peripheral arterial disease
- Chronic venous disease
- Musculoskeletal injuries of the testing leg in recent 3 months (that would influence practice schedule)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Sprinters
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.
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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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lower leg volume
Time Frame: change from baseline to 10 minutes after treatment
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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.
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change from baseline to 10 minutes after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pressure pain threshold
Time Frame: change from baseline to 10 minutes after treatment
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Pressure pain threshold was defined as the minimal amount of pressure that induced pain or discomfort.
Participant was asked to lie in prone position with ankle sticking out of the edge of table to let the ankle slightly plantar flexed without resistance.
The algometer was then placed at the muscle tendon junction of gastrocnemius on the testing leg.
The assessor compressed the site with the algometer and gradually increasing pressure until the participant said "stop" whenever he or she started to feel pain or discomfort.
At the same time, the second assessor read and recorded the value displayed on the algometer.
Measurements were measured two times and the intervals between each measurement were around 5 seconds apart.
These two readings were averaged and recorded for further data processing.
The algometer showed good intra-rater reliability with an ICC of 0.96.
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change from baseline to 10 minutes after treatment
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Perception of discomfort
Time Frame: change from baseline to 10 minutes after treatment
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Perception of discomfort such as tightness was assessed with visual analog scale (VAS), a grading scale range from 0 to 100 mm.
0 mm represented no pain or discomfort at all and 100 mm represented the greatest amount of pain or discomfort imaginable.
Participant drew a line that intersects the grading scale to show the amount of pain or discomfort that he or she experienced at that moment.
The assessor then used a ruler to measure the length from 0 mm to the intersecting line and recorded the value.
Perception of discomfort was assessed at each time point.
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change from baseline to 10 minutes after treatment
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Horizontal jump distance
Time Frame: change from baseline to 10 minutes after treatment
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Horizontal jump or standing long jump was a common performance test to examine the athlete's power and aerobic capacity.
The athlete started from a standing position and were then asked to jump forward as far as they could by bending their knees and swinging both arms.
A starting line was drawn and the expected landing region was placed with mat to prevent any possible injuries occurred.
After the jump, the distance from starting line to where the participant's heel landed was measured.
If the participant's heels were landed unleveled, the heel that was closer to the starting line was measured.
The participant jumped twice in each time point.
The jump distances in the same time point was then averaged.
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change from baseline to 10 minutes after treatment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201709058RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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