MassageNCT03821805
Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform
A study testing Foot reflexology massage in people with Massage and Anaerobic Exercise, run by University of Taipei.
Trial summary
Foot reflexology treatment provides acute and chronic effects on cardiovascular and hemodynamic functions. However, no information is available to us in regarding the treatment effect of foot reflexology after exercise. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Massage, Anaerobic Exercise, Aerobic Exercise
- What is being tested?
- Foot reflexology massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2016to 13 Jun 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undertake football/futsal training at least 3 times a week
- Age between 18 and 30 years old
Who cannot join
- History of severe neuromuscular injury
- Current lower extremity injury
- Current neurological diseases
About this study
Official title: Effects of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform After Yo Yo Intermittent Recovery Test and Repeated Sprint Test
Foot reflexology treatment provides acute and chronic effects on cardiovascular and hemodynamic functions. However, no information is available to us in regarding the treatment effect of foot reflexology after exercise. This study investigated the acute effect of foot reflexology treatment on heart rate variability after anaerobic-based and aerobic-based intermittent exercises.
Read the detailed description
The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be immediately modulated by foot reflexology massage. The acute benefits of foot reflexology intervention on cardiac sympathovagal balance can be considered as exercise recovery strategies in sports.
- Conditions
- Massage, Anaerobic Exercise, Aerobic Exercise
- Being tested
- Foot reflexology massage
- Keywords
- Heart rate variability, Arterial pulse waveform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot reflexology massageOther
Foot reflexology technique of Father Josef was used as massage intervention
| Study group | Role | What they receive |
|---|---|---|
| Foot reflexology massage group | Experimental | The duration of intervention was 30 min (15 min massage duration for each leg) Receives: Other: Foot reflexology massage |
| Control group | No intervention | Rest for 30 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
15 minutes resting electrocardiographic record at baseline and post-intervention phase
Measured: immediately following intervention phase
Secondary outcomes (1)
Arterial pulse waveform
15 minutes resting arterial plethysmographic waveform at baseline and post-intervention phase
Measured: immediately following intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start22 Dec 2016
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Taipei
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUNG-SHENG CHEN, University of Taipei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821805
- Sponsor's protocol ID
- UT-IRB-2016-017
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is protected by IRB application with a minimum of 3 years data storage.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform After Yo Yo Intermittent Recovery Test and Repeated Sprint Test
- ClinicalTrials.gov ID
- NCT03821805
- Acronym / sponsor ID
- UT-IRB-2016-017
- Conditions
- Massage, Anaerobic Exercise, Aerobic Exercise
- Keywords
- Heart rate variability, Arterial pulse waveform
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of TaipeiUniversity, hospital or other
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 30 Jan 2019 (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.
Foot reflexology treatment provides acute and chronic effects on cardiovascular and hemodynamic functions. However, no information is available to us in regarding the treatment effect of foot reflexology after exercise. This study investigated the acute effect of foot reflexology treatment on heart rate variability after anaerobic-based and aerobic-based intermittent exercises.
Detailed description
The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be immediately modulated by foot reflexology massage. The acute benefits of foot reflexology intervention on cardiac sympathovagal balance can be considered as exercise recovery strategies in sports.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot reflexology massage group | Experimental | Other: Foot reflexology massageThe duration of intervention was 30 min (15 min massage duration for each leg) |
| Control group | No intervention | –Rest for 30 min |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Undertake football/futsal training at least 3 times a week
- Age between 18 and 30 years old
Key exclusion criteria (3 listed)
- History of severe neuromuscular injury
- Current lower extremity injury
- Current neurological diseases
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 |
|---|---|---|
| Foot reflexology massageFoot reflexology technique of Father Josef was used as massage intervention | Other | Foot reflexology massage group |
Primary outcome
Heart rate variability
Time frame: immediately following intervention phase
15 minutes resting electrocardiographic record at baseline and post-intervention phase
1 secondary outcome
Arterial pulse waveform
Time frame: immediately following intervention phase
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 30 Jan 2019.
- Individual participant dataSharing planned: No. Individual participant data is protected by IRB application with a minimum of 3 years data storage.
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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 Foot reflexology massage in people with Massage and Anaerobic Exercise, run by University of Taipei.
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 2 inclusion and 3 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 30 Jan 2019. 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?
Heart rate variability (time frame: immediately following intervention phase). 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 30 Jan 2019.