Post-exercise Lower Extremity EdemaNCT03386019
The Efficacy of Lymphatic Massage on Lower Extremity Edema and Performance After Treadmill Exercise in Sprinter Compare to Static Stretching and Cold Water Immersion
A study testing Lymphatic massage, Static stretching and Cold water immersion in people with Post-exercise Lower Extremity Edema, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-exercise Lower Extremity Edema
- What is being tested?
- Lymphatic massage, Static stretching and Cold water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Nov 2017to 1 Dec 2017
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Lymphedema
- Peripheral arterial disease
- Chronic venous disease
- Musculoskeletal injuries of the testing leg in recent 3 months (that would influence practice schedule)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei
About this study
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.
- Conditions
- Post-exercise Lower Extremity Edema
- Being tested
- Lymphatic massage, Static stretching, Cold water immersion
- Keywords
- lymphatic massage, static stretching, cold water immersion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic massageOther
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.
Static stretchingOther
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.
Cold water immersionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lymphatic massage; Other: Static stretching; Other: Cold water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to 10 minutes after treatment
Secondary outcomes (3)
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.
Measured: change from baseline to 10 minutes after treatment
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.
Measured: change from baseline to 10 minutes after treatment
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.
Measured: change from baseline to 10 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start6 Nov 2017
- Primary completion28 Nov 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-exercise Lower Extremity EdemaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386019
- Sponsor's protocol ID
- 201709058RINA
- Status last verified
- Oct 2017
- First submitted
- 15 Dec 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03386019
- Acronym / sponsor ID
- 201709058RINA
- Conditions
- Post-exercise Lower Extremity Edema
- Keywords
- lymphatic massage, static stretching, cold water immersion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 29 Dec 2017 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sprinters | Experimental | Other: Lymphatic massage, Other: Static stretching, Other: Cold water immersionSprinters 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. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Lymphedema
- Peripheral arterial disease
- Chronic venous disease
- Musculoskeletal injuries of the testing leg in recent 3 months (that would influence practice schedule)
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 |
|---|---|---|
| Lymphatic massageOne 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. | Other | Sprinters |
| Static stretchingFor 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. | Other | Sprinters |
| Cold water immersionIn 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. | Other | Sprinters |
Primary outcome
Lower leg volume
Time frame: change from baseline to 10 minutes after treatment
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.
3 secondary outcomes
Pressure pain threshold
Time frame: change from baseline to 10 minutes after treatment
Perception of discomfort
Time frame: change from baseline to 10 minutes after treatment
Horizontal jump distance
Time frame: change from baseline to 10 minutes after treatment
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 29 Dec 2017.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphatic massage, Static stretching and Cold water immersion in people with Post-exercise Lower Extremity Edema, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Lower leg volume (time frame: change from baseline to 10 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2017.