SpondylarthropathySASPARNCT03319264
Sarcopenia in Axial and Peripheral Spondyloarthropathies
A study testing Dynamometry exam, Walking test and DXA measurement in people with Spondylarthropathy and Sarcopenia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in France. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spondylarthropathy, Sarcopenia
- What is being tested?
- Dynamometry exam, Walking test and DXA measurement
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2017to 4 Jul 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 18 to 80 years old
- Hospitalized or attending the rheumatology department for spondyloarthopathy.
Who cannot join
- no signed consent
- Immobilization for a period of more than 15 days during the last 3 months
- pregnant or breastfeeding woman
- Not affiliated to the national healthcare insurance
- difficulty in understanding French
- psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in France. In addition, sarcopenia is associated with decreased physical activity and increased risk of falls and fractures. A better characterization of the determinants of this muscular loss will allow to better detect and take care of it.
The aim is to conduct the first French study on the prevalence and severity of sarcopenia in patients with spondyloarthropathies and to study the variables that may be associated with it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).
This is a prospective interventional and monocentric study with minimal risks and constraints: patients will be included for one day for an evaluation of their sarcopenia by measuring their muscle strength, physical performance and body composition and recording of their socio-demographic and disease characteristics.
- Conditions
- Spondylarthropathy, Sarcopenia
- Being tested
- Dynamometry exam, Walking test, DXA measurement, SARQOL questionnaire, Life habits Questionnaire
- Keywords
- Spondylarthropathy, Sarcopenia, lean mass, fat mass
- Medical subject headings
- Spondylarthropathies, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamometry examOther
Prehension strength of the main hand will be assessed thanks to dynamometry, in order to evaluate patient's muscular strength
Walking testOther
A 4 metres walking test will be performed to assess patient's walking speed
DXA measurementRadiation
DXA measurement will be performed to assess patient's body composition
SARQOL questionnaireOther
Patient's quality of life will be assessed thanks to the SARQOL questionnaire
Life habits QuestionnaireBehavioural
Life habits Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients with SpA | Experimental | Patients included in this single group study will have 3 interventions to assess the severity of muscle loss :
* dynamometry exam
* walking test
* Dual-energy X-ray Absorptiometry (DXA) measurement Quality of life will be assessed with Sarcopenia \& Quality of Life (SARQOL) questionnaire. Patients will also fill a Life habits Questionnaire. Receives: Other: Dynamometry exam; Other: Walking test; Radiation: DXA measurement; Other: SARQOL questionnaire; Behavioral: Life habits Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
Muscular strength is the first outcome to evaluate sarcopenia
Measured: At day 1
Walking speed
Walking speed is a physical performance outcome, that is the second outcome to evaluate sarcopenia
Measured: At day 1
Muscular mass
Muscular mass is the third outcome to evaluate sarcopenia and will be assessed using DXA
Measured: Up to 4 month after inclusion
Secondary outcomes (6)
Alcohol consumption
Measured: At day 1
Tobacco consumption
Measured: At day 1
Time of sport practice per month
Number of hours of sport practice per month is the first outcome to evaluate patient's global physical activity.
Measured: At day 1
Physical activity rate in work
Physical activity rate in work can be light, medium, high or not applicable if the patient does not work ; it is the second outcome to evaluate patient's physical global activity.
Measured: At day 1
Average walking time in a week
Average walking time in a week is the third outcome to evaluate patient's physical global activity.
Measured: At day 1
Score at the SARQOL questionnaire
Quality of life will be assessed thanks to the SARQOL questionnaire (score between 0 and 100)
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start2 Nov 2017
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
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 SpondylarthropathyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319264
- Sponsor's protocol ID
- 69HCL17_0145
- Other IDs
- 2017-A02391-52
- Acronym
- SASPAR
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merle B, Cottard M, Sornay-Rendu E, Szulc P, Chapurlat R. Spondyloarthritis and Sarcopenia: Prevalence of Probable Sarcopenia and its Impact on Disease Burden: The Saspar Study. Calcif Tissue Int. 2023 Jun;112(6):647-655. doi: 10.1007/s00223-023-01074-3. Epub 2023 Mar 21.
PubMed 36944706
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia in Axial and Peripheral Spondyloarthropathies
- ClinicalTrials.gov ID
- NCT03319264
- Acronym / sponsor ID
- SASPAR / 69HCL17_0145
- Conditions
- Spondylarthropathy, Sarcopenia
- Keywords
- Spondylarthropathy, Sarcopenia, lean mass, fat mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 24 Oct 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.
Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in France. In addition, sarcopenia is associated with decreased physical activity and increased risk of falls and fractures. A better characterization of the determinants of this muscular loss will allow to better detect and take care of it.
The aim is to conduct the first French study on the prevalence and severity of sarcopenia in patients with spondyloarthropathies and to study the variables that may be associated with it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).
This is a prospective interventional and monocentric study with minimal risks and constraints: patients will be included for one day for an evaluation of their sarcopenia by measuring their muscle strength, physical performance and body composition and recording of their socio-demographic and disease characteristics.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with SpA | Experimental | Other: Dynamometry exam, Other: Walking test, Radiation: DXA measurement, Other: SARQOL questionnaire, Behavioral: Life habits QuestionnairePatients included in this single group study will have 3 interventions to assess the severity of muscle loss : * dynamometry exam * walking test * Dual-energy X-ray Absorptiometry (DXA) measurement Quality of life will be assessed with Sarcopenia \& Quality of Life (SARQOL) questionnaire. Patients will also fill a Life habits Questionnaire. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women, 18 to 80 years old
- Hospitalized or attending the rheumatology department for spondyloarthopathy.
Key exclusion criteria (6 listed)
- no signed consent
- Immobilization for a period of more than 15 days during the last 3 months
- pregnant or breastfeeding woman
- Not affiliated to the national healthcare insurance
- difficulty in understanding French
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 |
|---|---|---|
| Dynamometry examPrehension strength of the main hand will be assessed thanks to dynamometry, in order to evaluate patient's muscular strength | Other | Patients with SpA |
| Walking testA 4 metres walking test will be performed to assess patient's walking speed | Other | Patients with SpA |
| DXA measurementDXA measurement will be performed to assess patient's body composition | Radiation | Patients with SpA |
| SARQOL questionnairePatient's quality of life will be assessed thanks to the SARQOL questionnaire | Other | Patients with SpA |
| Life habits QuestionnaireLife habits Questionnaire | Behavioural | Patients with SpA |
Primary outcome
Muscular strength
Time frame: At day 1
Muscular strength is the first outcome to evaluate sarcopenia
Walking speed
Time frame: At day 1
Walking speed is a physical performance outcome, that is the second outcome to evaluate sarcopenia
Muscular mass
Time frame: Up to 4 month after inclusion
Muscular mass is the third outcome to evaluate sarcopenia and will be assessed using DXA
6 secondary outcomes
Alcohol consumption
Time frame: At day 1
Tobacco consumption
Time frame: At day 1
Time of sport practice per month
Time frame: At day 1
Physical activity rate in work
Time frame: At day 1
Average walking time in a week
Time frame: At day 1
Score at the SARQOL questionnaire
Time frame: At day 1
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 19 Dec 2025.
- Results publication: PubMed 36944706Merle B, Cottard M, Sornay-Rendu E, Szulc P, Chapurlat R. Spondyloarthritis and Sarcopenia: Prevalence of Probable Sarcopenia and its Impact on Disease Burden: The Saspar Study. Calcif Tissue Int. 2023 Jun;112(6):647-655. doi: 10.1007/s00223-023-01074-3. Epub 2023 Mar 21.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamometry exam, Walking test and DXA measurement in people with Spondylarthropathy and Sarcopenia, run by Hospices Civils de Lyon at 1 site in France.
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 6 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 19 Dec 2025. 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 France. 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?
Muscular strength (time frame: At day 1). The study lists 3 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 NCT03319264, 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 19 Dec 2025.