Health BehaviorNCT01765387
Spa Effects After Exercise
A study testing Spa session in people with Health Behavior, run by University of Malaga at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled repeated measures, single-blind, trial is conducted. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Spa session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Jun 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 5-10 hours/wk of physical activity, no pharmaceutical drug intake in the past 3 months,
- No use of tobacco or other addictive substances,
- No pain symptoms from at least one year,
- No contradiction for high-intensity exercise following previous study about recovery after exercise
Who cannot join
- Signs or symptoms of medical disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SPA THERAPY AS RECOVERY PROCEDURE AFTER EXERCISE: A PRAGMATIC CONTROLLED TRIAL
The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled repeated measures, single-blind, trial is conducted. Thirty-four recreational sportspeople are required to visit a Sport-Centre and are assigned to a Spa-therapy or rest in a bed (control group) after complete a spinning session.
Read the detailed description
Subjects perform the recovery session after completing the exercise protocol. Participants are allocated to the control or intervention group following an order of arrival to the study.
The spinning session is performed using the same protocol for all participants after 24h physical rest. They were asked to perform this session as a regular spinning class. The session is carried out in the afternoon (room temperature 22±3.5°C) on a modified spinning bike (Keiser®, M3). They are allowed to drink water during the session and performed the test, while they listen a compilation of music that lasted 50min composed of 9 tracks.
Each track corresponds to a specific phase of the spinning session. The phases being labeled as warm-up, sitting, seated climbing, jumping, and running, based on the official spinning program manual. Some phases are repeated during the session, the compilation being purposely designed for beginner practitioners of a spinning class. In addition to the music protocol, the participants are asked to maintain a pedal stroke cadence that had previously been established for each track. For the resistance applied to the flywheel, the participants are free to adjust it according to their sensation and interpretation of the spinning session.
Recovery Procedures
A cycle of 3 Vichy shower and whirlpool baths are applied during 30-minutes period. Vichy sedative shower are applied for 90-120 sec to the sides of the trunk and the abdomen, avoiding as much as possible the gall bladder area, at a temperature of 36-38ºC. A short, partial jet spray followed the shower. A whirlpool bath is administered where subjects immersed the body until their clavicle level for a 10min period with a water temperature ranging 33.5-35.5 ºC. Aromatherapy application using lavender and chamomile oils is used in all Spa therapy sessions.
The control group performed a rest session in supine position in a room with neutral temperature condition with a same duration to Spa session. Participants of both groups are encouraged to drink water "ad libitum" to prevent dehydration.
- Conditions
- Health Behavior
- Being tested
- Spa session
- Keywords
- Spatherpy, Aerobic exercise
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa sessionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Spa therapy | Experimental | A cycle of 3 Vichy shower and whirlpool baths are applied during 30-minutes period. Vichy sedative shower is applied for 90-120 sec to the sides of the trunk and the abdomen, avoiding as much as possible the gall bladder area, at a temperature of 36-38ºC. A short, partial jet spray followed the shower. A whirlpool bath is administered where subjects immersed the body until their clavicle level for a 10min period with a water temperature ranging 33.5-35.5 ºC. Aromatherapy application using lavender and chamomile oils is used in all Spa therapy sessions. Receives: Behavioral: Spa session |
| Control group | No intervention | The control group perform a rest session in supine position in a room with neutral temperature condition with a same duration to Spa session. Participants of both groups are encouraged to drink water "ad libitum" to prevent dehydration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: baseline, 5 minutes after spinning session, 5 minutes after recovery session
Secondary outcomes (2)
heart rate
Measured: baseline, 5 minutes after spinning session, 5 minutes after recovery session
vertical jump test
Measured: baseline, 5 minutes after spinning session, 5 minutes after recovery session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Manuel Arroyo Morales, PhD, Principal investigator, University of Granada, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765387
- Sponsor's protocol ID
- FGEUGR01
- Status last verified
- Jan 2013
- First submitted
- 7 Jan 2013
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cuesta-Vargas AI, Trave-Mesa A, Vera-Cabrera A, Cruz-Terron D, Castro-Sanchez AM, Fernandez-de-las-Penas C, Arroyo-Morales M. Hydrotherapy as a recovery strategy after exercise: a pragmatic controlled trial. BMC Complement Altern Med. 2013 Jul 18;13:180. doi: 10.1186/1472-6882-13-180.
PubMed 23866725
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPA THERAPY AS RECOVERY PROCEDURE AFTER EXERCISE: A PRAGMATIC CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT01765387
- Acronym / sponsor ID
- FGEUGR01
- Conditions
- Health Behavior
- Keywords
- Spatherpy, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Jan 2013 (estimated)
- 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.
The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled repeated measures, single-blind, trial is conducted. Thirty-four recreational sportspeople are required to visit a Sport-Centre and are assigned to a Spa-therapy or rest in a bed (control group) after complete a spinning session.
Detailed description
Subjects perform the recovery session after completing the exercise protocol. Participants are allocated to the control or intervention group following an order of arrival to the study.
The spinning session is performed using the same protocol for all participants after 24h physical rest. They were asked to perform this session as a regular spinning class. The session is carried out in the afternoon (room temperature 22±3.5°C) on a modified spinning bike (Keiser®, M3). They are allowed to drink water during the session and performed the test, while they listen a compilation of music that lasted 50min composed of 9 tracks.
Each track corresponds to a specific phase of the spinning session. The phases being labeled as warm-up, sitting, seated climbing, jumping, and running, based on the official spinning program manual. Some phases are repeated during the session, the compilation being purposely designed for beginner practitioners of a spinning class. In addition to the music protocol, the participants are asked to maintain a pedal stroke cadence that had previously been established for each track. For the resistance applied to the flywheel, the participants are free to adjust it according to their sensation and interpretation of the spinning session.
Recovery Procedures
A cycle of 3 Vichy shower and whirlpool baths are applied during 30-minutes period. Vichy sedative shower are applied for 90-120 sec to the sides of the trunk and the abdomen, avoiding as much as possible the gall bladder area, at a temperature of 36-38ºC. A short, partial jet spray followed the shower. A whirlpool bath is administered where subjects immersed the body until their clavicle level for a 10min period with a water temperature ranging 33.5-35.5 ºC. Aromatherapy application using lavender and chamomile oils is used in all Spa therapy sessions.
The control group performed a rest session in supine position in a room with neutral temperature condition with a same duration to Spa session. Participants of both groups are encouraged to drink water "ad libitum" to prevent dehydration.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spa therapy | Experimental | Behavioral: Spa sessionA cycle of 3 Vichy shower and whirlpool baths are applied during 30-minutes period. Vichy sedative shower is applied for 90-120 sec to the sides of the trunk and the abdomen, avoiding as much as possible the gall bladder area, at a temperature of 36-38ºC. A short, partial jet spray followed the shower. A whirlpool bath is administered where subjects immersed the body until their clavicle level for a 10min period with a water temperature ranging 33.5-35.5 ºC. Aromatherapy application using lavender and chamomile oils is used in all Spa therapy sessions. |
| Control group | No intervention | –The control group perform a rest session in supine position in a room with neutral temperature condition with a same duration to Spa session. Participants of both groups are encouraged to drink water "ad libitum" to prevent dehydration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 5-10 hours/wk of physical activity, no pharmaceutical drug intake in the past 3 months,
- No use of tobacco or other addictive substances,
- No pain symptoms from at least one year,
- No contradiction for high-intensity exercise following previous study about recovery after exercise
Key exclusion criteria (1 listed)
- Signs or symptoms of medical disease
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 |
|---|---|---|
| Spa session | Behavioural | Spa therapy |
Primary outcome
blood pressure
Time frame: baseline, 5 minutes after spinning session, 5 minutes after recovery session
2 secondary outcomes
heart rate
Time frame: baseline, 5 minutes after spinning session, 5 minutes after recovery session
vertical jump test
Time frame: baseline, 5 minutes after spinning session, 5 minutes after recovery session
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 25 Mar 2015.
- Derived from this study: PubMed 23866725Cuesta-Vargas AI, Trave-Mesa A, Vera-Cabrera A, Cruz-Terron D, Castro-Sanchez AM, Fernandez-de-las-Penas C, Arroyo-Morales M. Hydrotherapy as a recovery strategy after exercise: a pragmatic controlled trial. BMC Complement Altern Med. 2013 Jul 18;13:180. doi: 10.1186/1472-6882-13-180.
Related trials for Health Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
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.
Manuel Arroyo Morales, PhD principal investigator
University of Granada, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa session in people with Health Behavior, run by University of Malaga at 1 site in Spain.
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 4 inclusion and 1 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 25 Mar 2015. 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 Spain. 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?
blood pressure (time frame: baseline, 5 minutes after spinning session, 5 minutes after recovery session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01765387, which also lists 1 linked publication.
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 25 Mar 2015.