Post-exercise Lower Extremity Edema Clinical Trial
Official title:
The Efficacy of Lymphatic Massage on Lower Extremity Edema and Performance After Treadmill Exercise in Sprinter Compare to Static Stretching and Cold Water Immersion
| Verified date | October 2017 |
| Source | National Taiwan University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | December 1, 2017 |
| Est. primary completion date | November 28, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 30 Years |
| Eligibility |
Inclusion criteria: 1. 20-30 years-old of age. 2. Sprinters participate in 100-meter, 200-meter or 400-meter sprint events. 3. Trainings at least 5 days per week and at least 2 hours per day. Exclusion criteria: 1. Lymphedema 2. Peripheral arterial disease 3. Chronic venous disease 4. Musculoskeletal injuries of the testing leg in recent 3 months (that would influence practice schedule) |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Pressure pain threshold | 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. | change from baseline to 10 minutes after treatment | |
| Secondary | Perception of discomfort | 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. | change from baseline to 10 minutes after treatment | |
| Secondary | Horizontal jump distance | 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. | change from baseline to 10 minutes after treatment |