AdultsNCT06042218
Xiaxi Program for Back Health
A study testing Xiaxi intervention program in people with Adults and No Sagittal Spine Disposition Disorder, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Progressive deformity from the optimal spinal curvatures is a degenerative disorder related to progressive ageing that affects an increasing number of adults. This is one of the main affectations on the health of adults, being its cause multifactorial. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adults, No Sagittal Spine Disposition Disorder, No Surgery on the Spine or the Hamstring
- What is being tested?
- Xiaxi intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 11 Sep 2023to 15 Dec 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults from 20 to 60 years-old
- not have a doctor-diagnosed sagittal spine disposition disorder
- not have had surgery on the spine or the hamstring musculature
- not being under a specific treatment for spinal pathology
- not involve in structured exercise programs before or during the time of the study
Who cannot join
- not being able to complete all the evaluations
- for members of the experimental group missing more than 20% of the sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Back. Analysis of the Acute and Chronic Effects of a Program of Body and Postural Work Through "Xiaxi Aligns Your Health"
Progressive deformity from the optimal spinal curvatures is a degenerative disorder related to progressive ageing that affects an increasing number of adults. This is one of the main affectations on the health of adults, being its cause multifactorial. That is why a totally effective intervention has not yet been found that allows obtaining a substantial improvement in all the adults who suffer from it. However, certain physical programs that include mind-body work have been effective, but research is limited and the results are inconclusive. For this reason, this research arises, in which a training protocol has been designed using an instrument called Xiaxi with which the body-mind work is prioritized.
The aims of this study were: 1) to evaluate the effects of a 12-weeks Xiaxi® exercise program on the sagittal spinal disposition and hamstring extensibility of adults, and 2) to determine whether the weekly training frequency influenced the changes found on sagittal spinal disposition and hamstring extensibility with Xiaxi® training program.
The present investigation is composed of two data collections that will be carried out before and after a twelve-week intervention. Two intervention groups and a control group make up the sample, with one of the intervention groups attending Xiaxi training once a week and the other intervention group twice a week. The control group will only attend the measurements, but will not participate in the intervention.
- Conditions
- Adults, No Sagittal Spine Disposition Disorder, No Surgery on the Spine or the Hamstring, No Specific Treatment for Spinal Pathology, Not Involved in Structured Exercise Programs Before or During the Time of the Study
- Being tested
- Xiaxi intervention program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaxi intervention programBehavioural
The Xiaxi sessions will follow the same structure in both intervention groups. First of all, 8-minute warm-up where the participants will work on: postural awareness; active static stretching of the pectoral, hamstring and psoas muscles; and mobility. The main part will include the following blocks of content during the 12 weeks of intervention (46 minutes will be spent on this part in each session): breathing; mobility; active and dynamic static stretching of the tonic muscles with effects on the spine dynamic; strength of the phasic muscles with effects on the spine dynamic, alternating upper limb, lower limb and core; postural awareness; and passive static stretching of the tonic muscles with effects on the spine dynamic. The cool down will be similar in each session (6 minutes) and will focus on: postural awareness and passive static stretching of the pectoral, hamstring and psoas muscles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group who trained one day a week | Experimental | This intervention group will attend a weekly sixty-minute training session with the Xiaxi machine during the twelve weeks of the intervention. The sessions will include flexibility and strength-resistance work, as well as postural awareness. Receives: Behavioral: Xiaxi intervention program |
| Experimental group who trained two days a week | Experimental | This intervention group will attend two weekly sixty-minute training sessions with the Xiaxi machine during the twelve weeks of the intervention. The sessions will include flexibility and strength-resistance work, as well as postural awareness. Receives: Behavioral: Xiaxi intervention program |
| Control Group | No intervention | They will not attend any type of intervention. They will continue to perform their daily activities without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagittal spinal curvature in relaxed standing
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a standing position, adopting the usual and daily position. The unit of measurement will be the same, using the grades achieved.
Measured: Up to 12 weeks
Sagittal spinal curvature in active alignment in standing
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a standing position, but in this case the subject will be asked to rectify the arrangement of the spine to be as straight as possible. The unit of measurement will be the same, using the grades achieved.
Measured: Up to 12 weeks
Sagittal spinal curvature in relaxed sitting
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a seated position, maintaining a habitual, everyday position. The unit of measurement will be the same, using the grades achieved.
Measured: Up to 12 weeks
Sagittal spinal curvature during Macrae & Wright test
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the Macrae \& Wright test, in which the subject will be asked to perform maximum trunk flexion from a seated position. The unit of measurement will be the same, using the grades achieved.
Measured: Up to 12 weeks
Sagittal spinal curvature during sit and reach test.
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the sit and reach test, in which the subject will be asked to perform a maximum trunk flexion from a seated position and with the soles of the feet resting on a box, keeping the knees fully extended during the same, to push a ribbon the maximum distance through the box. The unit of measurement will be the degrees of the curvatures of the back, as well as the distance reached in the test.
Measured: Up to 12 weeks
Sagittal spinal curvature during toe touch test
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the toe touch test. In this test, the subject will be asked to perform a maximum trunk flexion in which he/she will try to reach the maximum possible distance from a standing position on a box. The knees will be kept fully extended during the test and an attempt will be made to reach the feet, and this distance may be exceeded if necessary. The unit of measurement will be the degrees of the curvatures of the back, as well as the distance reached in the test.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start11 Sep 2023
- Primary completion8 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Almeria
- Responsible party
- Principal investigator, Raquel Vaquero-Cristóbal, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042218
- Sponsor's protocol ID
- UALBIO2023/005
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez-Rosales E, Casimiro-Andujar AJ, Artes-Rodriguez EM. Sex-specific acute effects of postural hammock exercise on autonomic regulation and plantar pressure in individuals with low back pain. J Bodyw Mov Ther. 2026 Jun;46:295-301. doi: 10.1016/j.jbmt.2025.11.026. Epub 2025 Nov 21.
PubMed 41927188Vaquero-Cristobal R, Marcos-Pardo PJ, Mateo-Orcajada A, Cejudo A, de Baranda PS, Casimiro-Andujar AJ. Effects of a 12-week Xiaxi(R) exercise program on hamstring extensibility, sagittal spine posture and pelvic disposition of university employees: A randomized controlled trial. J Bodyw Mov Ther. 2025 Sep;43:58-81. doi: 10.1016/j.jbmt.2025.04.008. Epub 2025 Apr 15.
PubMed 40483164
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Back. Analysis of the Acute and Chronic Effects of a Program of Body and Postural Work Through "Xiaxi Aligns Your Health"
- ClinicalTrials.gov ID
- NCT06042218
- Acronym / sponsor ID
- UALBIO2023/005
- Conditions
- Adults, No Sagittal Spine Disposition Disorder, No Surgery on the Spine or the Hamstring, No Specific Treatment for Spinal Pathology, Not Involved in Structured Exercise Programs Before or During the Time of the Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Collaborators
- Universidad de Almeria
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 8 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 18 Sep 2023 (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.
Progressive deformity from the optimal spinal curvatures is a degenerative disorder related to progressive ageing that affects an increasing number of adults. This is one of the main affectations on the health of adults, being its cause multifactorial. That is why a totally effective intervention has not yet been found that allows obtaining a substantial improvement in all the adults who suffer from it. However, certain physical programs that include mind-body work have been effective, but research is limited and the results are inconclusive. For this reason, this research arises, in which a training protocol has been designed using an instrument called Xiaxi with which the body-mind work is prioritized.
The aims of this study were: 1) to evaluate the effects of a 12-weeks Xiaxi® exercise program on the sagittal spinal disposition and hamstring extensibility of adults, and 2) to determine whether the weekly training frequency influenced the changes found on sagittal spinal disposition and hamstring extensibility with Xiaxi® training program.
The present investigation is composed of two data collections that will be carried out before and after a twelve-week intervention. Two intervention groups and a control group make up the sample, with one of the intervention groups attending Xiaxi training once a week and the other intervention group twice a week. The control group will only attend the measurements, but will not participate in the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group who trained one day a week | Experimental | Behavioral: Xiaxi intervention programThis intervention group will attend a weekly sixty-minute training session with the Xiaxi machine during the twelve weeks of the intervention. The sessions will include flexibility and strength-resistance work, as well as postural awareness. |
| Experimental group who trained two days a week | Experimental | Behavioral: Xiaxi intervention programThis intervention group will attend two weekly sixty-minute training sessions with the Xiaxi machine during the twelve weeks of the intervention. The sessions will include flexibility and strength-resistance work, as well as postural awareness. |
| Control Group | No intervention | –They will not attend any type of intervention. They will continue to perform their daily activities without intervention. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- adults from 20 to 60 years-old
- not have a doctor-diagnosed sagittal spine disposition disorder
- not have had surgery on the spine or the hamstring musculature
- not being under a specific treatment for spinal pathology
- not involve in structured exercise programs before or during the time of the study
Key exclusion criteria (2 listed)
- not being able to complete all the evaluations
- for members of the experimental group missing more than 20% of the sessions
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 |
|---|---|---|
| Xiaxi intervention programThe Xiaxi sessions will follow the same structure in both intervention groups. First of all, 8-minute warm-up where the participants will work on: postural awareness; active static stretching of the pectoral, hamstring and psoas muscles; and mobility. The main part will include the following blocks of content during the 12 weeks of intervention (46 minutes will be spent on this part in each session): breathing; mobility; active and dynamic static stretching of the tonic muscles with effects on the spine dynamic; strength of the phasic muscles with effects on the spine dynamic, alternating upper limb, lower limb and core; postural awareness; and passive static stretching of the tonic muscles with effects on the spine dynamic. The cool down will be similar in each session (6 minutes) and will focus on: postural awareness and passive static stretching of the pectoral, hamstring and psoas muscles. | Behavioural | Experimental group who trained one day a week, Experimental group who trained two days a week |
Primary outcome
Sagittal spinal curvature in relaxed standing
Time frame: Up to 12 weeks
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a standing position, adopting the usual and daily position. The unit of measurement will be the same, using the grades achieved.
Sagittal spinal curvature in active alignment in standing
Time frame: Up to 12 weeks
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a standing position, but in this case the subject will be asked to rectify the arrangement of the spine to be as straight as possible. The unit of measurement will be the same, using the grades achieved.
Sagittal spinal curvature in relaxed sitting
Time frame: Up to 12 weeks
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject in a seated position, maintaining a habitual, everyday position. The unit of measurement will be the same, using the grades achieved.
Sagittal spinal curvature during Macrae & Wright test
Time frame: Up to 12 weeks
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the Macrae \& Wright test, in which the subject will be asked to perform maximum trunk flexion from a seated position. The unit of measurement will be the same, using the grades achieved.
Sagittal spinal curvature during sit and reach test.
Time frame: Up to 12 weeks
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the sit and reach test, in which the subject will be asked to perform a maximum trunk flexion from a seated position and with the soles of the feet resting on a box, keeping the knees fully extended during the same, to push a ribbon the maximum distance through the box. The unit of measurement will be the degrees of the curvatures of the back, as well as the distance reached in the test.
Sagittal spinal curvature during toe touch test
Time frame: Up to 12 weeks
The thoracic angle, lumbar angle and pelvic tilt will be measured with the subject performing the toe touch test. In this test, the subject will be asked to perform a maximum trunk flexion in which he/she will try to reach the maximum possible distance from a standing position on a box. The knees will be kept fully extended during the test and an attempt will be made to reach the feet, and this distance may be exceeded if necessary. The unit of measurement will be the degrees of the curvatures of the back, as well as the distance reached in the test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 41927188Martinez-Rosales E, Casimiro-Andujar AJ, Artes-Rodriguez EM. Sex-specific acute effects of postural hammock exercise on autonomic regulation and plantar pressure in individuals with low back pain. J Bodyw Mov Ther. 2026 Jun;46:295-301. doi: 10.1016/j.jbmt.2025.11.026. Epub 2025 Nov 21.
- Derived from this study: PubMed 40483164Vaquero-Cristobal R, Marcos-Pardo PJ, Mateo-Orcajada A, Cejudo A, de Baranda PS, Casimiro-Andujar AJ. Effects of a 12-week Xiaxi(R) exercise program on hamstring extensibility, sagittal spine posture and pelvic disposition of university employees: A randomized controlled trial. J Bodyw Mov Ther. 2025 Sep;43:58-81. doi: 10.1016/j.jbmt.2025.04.008. Epub 2025 Apr 15.
- Individual participant dataSharing planned: No
Related trials for Adults
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B-All
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
Microscopic Colitis
Not yet recruitingObservational study
A Study to Describe Patient REal-world FitusiRan ExpeRience
Hemophilia A or B
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 Xiaxi intervention program in people with Adults and No Sagittal Spine Disposition Disorder, run by Universidad Católica San Antonio de Murcia 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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?
Results are not available in the source record.
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?
Sagittal spinal curvature in relaxed standing (time frame: Up to 12 weeks). The study lists 6 primary outcomes in all. 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 NCT06042218, which also lists 2 linked publications.
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 18 Sep 2023.