Ankylosing SpondylitisSPIKENCT04089774
Benefit of Adapted Physical Activity for Patients Suffering From Ankylosing Spondylitis
A study testing Adapted Physical Activity (APA) in people with Ankylosing Spondylitis, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
The current management of Spondylarthritis Ankylosant (SA), according to the recommendations of the HAS (High Authority of Health), must be a multidisciplinary global approach coordinated by the rheumatologist combining a pharmacological aspect (NSAID, analgesics, biotherapy ...) and not pharmacological (physical… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Adapted Physical Activity (APA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2019to 14 Jun 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between 18 and 60 years old
- Present Axial Spondylitis meeting the criteria of ASAS 2009
- Be on treatment with biotherapy, stable dose for at least 6 months
- Complete the ALD criteria
- Have a BASFI score at inclusion ≤ 5
- Have signed the consent form
Show all 10Show fewer
- Being able to be compliant to the study schedule (mobile and available)
- To be clinically stable for at least 6 months
- Affiliation to a social security scheme or beneficiary of such a scheme
- Does not present a contraindication to the practice of a physical activity
Who cannot join
- Regularly practice a sports activity (≥ 1hour / week)
- Have a severe handicap limiting the gestures of daily life (dressing, walking, etc ...)
- Have another significant osteo-articular pathology (Rheumatoid arthritis osteoarthritis, hip prosthesis ...)
- Have a bamboo column
- Being pregnant or planning to be pregnant in the coming year
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Saint Joseph
Marseille, Bouches DU Rhone, 13008
ASSELATE BELKACEM, 00491807016, basselate@hopital-saint-joseph.fr
About this study
Official title: Comparison of the Benefit Experienced by Patients With Ankylosing Spondylitis, Under Biotherapy, During Management by an Adapted Physical Activity Compared to a Standard Treatment by Kinesitherapy.
The current management of Spondylarthritis Ankylosant (SA), according to the recommendations of the HAS (High Authority of Health), must be a multidisciplinary global approach coordinated by the rheumatologist combining a pharmacological aspect (NSAID, analgesics, biotherapy ...) and not pharmacological (physical treatments, educational approaches, social measures ...). The therapeutic aim of this management is to achieve a low level of activity of the disease and a decrease of the repercussion of this one in the daily life of the patient.
The standard physical treatment currently provided is physiotherapy. This can be prescribed throughout the disease by the rheumatologist, adapted to the stage of AS and the clinical condition of the patient. The medical teams note in their daily practice that there may be a lack of attendance of patients at prescribed physiotherapy sessions. This has been confirmed in research on certain chronic rheumatic diseases, including AS, for which patients became less adherent to physical treatments and thus lost the expected benefits, particularly in terms of the functional impact of AS in the patient's daily life. (BASFI). Various studies have also shown that combining several physical activities (including aerobic and muscle building) or / and performing them in groups at a regular frequency (three times a week) could significantly improve several AS parameters, including BASFI.
From these different findings, we hypothesized that a multidisciplinary treatment combining a "cardio training" with muscle strengthening, supervised by qualified sports coaches, for a year, could reduce the impact of SA in the daily life of patients balanced by a biotherapy, compared to standard physiotherapy. This original care is part of the Adapted Physical Activity (APA), whose application decree came into force on March 1, 2017 and allows doctors to prescribe a physical therapy tailored to the needs of the patient. At present, the APA remains at the expense of the patients in ALD and in some cases, it can be supported, partially or totally, by the complementary health. APA could therefore be an alternative and / or complementary to physiotherapy as a physical therapy in the management of AS, in addition to pharmacological treatments.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Adapted Physical Activity (APA)
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity (APA)Behavioural
Supported by an Adapted Physical Activity (APA), at the rate of 3 sessions per week supervised by the association SCO STE MARGUERITE, spread over 12 months
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity (APA) | Experimental | Supported by an Adapted Physical Activity (APA), at the rate of 3 sessions per week supervised by the association SCO STE MARGUERITE, spread over 12 months Receives: Behavioral: Adapted Physical Activity (APA) |
| Kiné | No intervention | Standard physiotherapy treatment, at least 20 sessions, renewed at least once, spread over 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean variation of the BASFI score (Bath Ankylosing Spondylitis Functional Index) over a period of 18 months
The primary endpoint is the mean change in BASFI score (functional index of ankylosing spondylitis) between 12 months of management (or M12), and baseline (or M0), compared between the 2 groups. It will be noted BASFI (M12-M0). Patients follow-up will be done during 18 months.
BASFI is a self-administered questionnaire that assesses the functional impact of the disease on the patient's life. This tool consists of 10 questions to answer a visual evaluation of 10 cm (0 for "easy" and 10 for "impossible").
Measured: 18 MONTHS
Secondary outcomes (9)
The mean variation of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
This tool assesses disease activity based on the patient's response to 6 questions related to fatigue, joint and spinal joint pain, localized spot sensitivity, and morning stiffness (duration). and degree). Each answer can range from 0 (absent) to 10 cm (extreme) on a visual analogue scale or Likert scale. First, calculate the average for answers 5 and 6 and then calculate the average of the 5 values (the average value of answers 5 and 6 and the value of answers to the first 4 questions). It is a fast tool (with a filling time per patient from 30 seconds to 2 minutes), reliable and valid, also used for "routine" follow-up, at the request of the practitioner. This questionnaire is completed by the patient referring to his feelings during the last forty-eight hours.
Measured: 18 MONTHS
The mean variation of C-reactive protein (CRP) and sedimentation rate (VS) over a period of 18 months
These 2 biomarkers of inflammation are regularly dosed as part of a "classical" follow-up by the rheumatologist, in addition to a more complete biological assessment. This assessment can be performed in the laboratory of biological analyzes of the choice of the patient. Patients follow-up will be done during 18 months.
These values are retrieved at visits M0, M6, M12 and M18.
Measured: 18 MONTHS
The mean variation of ASDAS (Ankylosing Spondylitis Disease Activity Score).
It is a new composite index to evaluate disease activity that combines 5 variables: 3 questions from BASDAI (2nd, 3rd and 6th), the value of CRP (or VS, if CRP not available ) and the EVA of the Global Assessment (EVA-AG) by the patient. This score has a good sensitivity and is calculated using the following formula:
0.12 x Back Pain (0 to 10) + 0.06 x Duration of Morning Stiffness (from 0 to 10) + 0.11 x Patient Global (0 to 10) + 0.07 x Peripheral Bread / Swelling (0 to 10) + 0.58 x Ln (CRP (mg / l) +1)
Measured: 18 MONTHS
The mean variation of the score of the Visual Analogue Scale of Global Appreciation (EVA-AG) over a period of 18 months.
The EVA-AG is a visual scale graduated from 0 (worst health condition imaginable) to 10 (best health imaginable) and the patient must indicate the appreciated value of his overall health condition on the scale and within a framework Reserve. Patients follow-up will be done during 18 months.
The questionnaire is completed by the patient at each visit: M0, M6, M12 and M18.
Measured: 18 MONTHS
The mean variation in NSAID consumption (Anti-Inflammatory Non Steroidal) over a period of 18 months.
The consumption of NSAIDs throughout the study is measured by completion by the physician of a questionnaire, based on the interview of the patient, which makes it possible to obtain the ASAS-NSAIDs (Assessment of SpondyloArthritis International Society - No Steroidal Anti-Inflammatory Drugs) score. It is calculated using a formula based on the daily dosage, the number of shots per week and the period of interest in days. Patients follow-up will be done during 18 months.
This score is calculated at each visit over the 6 months preceding the visits: M0, M6, M12 and M18.
Measured: 18 MONTHS
The mean variation in the consumption of analgesics.
The average consumption of analgesics, in the 6 months preceding the visit, is collected by the investigating doctor during the interrogation of the patient and transcribed in his medical file.
Each treatment is informed as well as its daily dosage, the average number of days of weekly intake and the duration of it
Measured: 18 MONTHS
The average variation in medical consumption over a period of 18 months
The medical consumption corresponds to the retranscription of all consultations, hospitalizations or other medical or paramedical care, in connection with his SA, carried out by the patient in the 6 months preceding the visit. Only non-research-related treatment consumptions are collected by the investigating physician and transcribed in his medical file. Physiotherapy sessions of the patient included in group 2, are not considered medical consumption, for example. Patients follow-up will be done during 18 months.
This information is collected at each visit on the 6 months preceding the visits: M0, M6, M12 and M18.
Measured: 18 MONTHS
Variation of items in the Patient Questionnaire.
The Patient Questionnaire is a questionnaire, to be completed by the patient, composed of 4 questions with 4 possible answers each time and a free commentary part.
This questionnaire makes it possible to compare between the 2 groups, the adhesion and the satisfaction of the patients to their prescribed care and the frequency of realization of the recommended individual exercises, during the period of dedicated observation, as well as in follow-up.
Measured: 18 MONTHS
The average change in scores on the Quality of Life Questionnaire (short form) SF-12.
The SF-12 is a self-questionnaire, non-pathology specific and can be administered to the general population, to assess the quality of life of the patient. This tool is an abbreviated version of the "Medical Outcomes Study Short-Form General Health Survey" (SF-36) with only 12 items out of 36, to assess the mental and physical health of the subject
Measured: 18 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start14 May 2019
- Primary completion14 Jun 2022 (estimated)
- Study completion14 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Arniaud, Hospital St. Joseph, Marseille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089774
- Sponsor's protocol ID
- ID RCB 2019-A00138-49
- Acronym
- SPIKE
- Status last verified
- Sep 2019
- First submitted
- 26 Jun 2019
- Last updated
- 13 Sep 2019
- 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 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Benefit Experienced by Patients With Ankylosing Spondylitis, Under Biotherapy, During Management by an Adapted Physical Activity Compared to a Standard Treatment by Kinesitherapy.
- ClinicalTrials.gov ID
- NCT04089774
- Acronym / sponsor ID
- SPIKE / ID RCB 2019-A00138-49
- Conditions
- Ankylosing Spondylitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 14 Jun 2022 (estimated)
- Study completion
- 14 Jun 2022 (estimated)
- First posted
- 13 Sep 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.
The current management of Spondylarthritis Ankylosant (SA), according to the recommendations of the HAS (High Authority of Health), must be a multidisciplinary global approach coordinated by the rheumatologist combining a pharmacological aspect (NSAID, analgesics, biotherapy ...) and not pharmacological (physical treatments, educational approaches, social measures ...). The therapeutic aim of this management is to achieve a low level of activity of the disease and a decrease of the repercussion of this one in the daily life of the patient.
The standard physical treatment currently provided is physiotherapy. This can be prescribed throughout the disease by the rheumatologist, adapted to the stage of AS and the clinical condition of the patient. The medical teams note in their daily practice that there may be a lack of attendance of patients at prescribed physiotherapy sessions. This has been confirmed in research on certain chronic rheumatic diseases, including AS, for which patients became less adherent to physical treatments and thus lost the expected benefits, particularly in terms of the functional impact of AS in the patient's daily life. (BASFI). Various studies have also shown that combining several physical activities (including aerobic and muscle building) or / and performing them in groups at a regular frequency (three times a week) could significantly improve several AS parameters, including BASFI.
From these different findings, we hypothesized that a multidisciplinary treatment combining a "cardio training" with muscle strengthening, supervised by qualified sports coaches, for a year, could reduce the impact of SA in the daily life of patients balanced by a biotherapy, compared to standard physiotherapy. This original care is part of the Adapted Physical Activity (APA), whose application decree came into force on March 1, 2017 and allows doctors to prescribe a physical therapy tailored to the needs of the patient. At present, the APA remains at the expense of the patients in ALD and in some cases, it can be supported, partially or totally, by the complementary health. APA could therefore be an alternative and / or complementary to physiotherapy as a physical therapy in the management of AS, in addition to pharmacological treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity (APA) | Experimental | Behavioral: Adapted Physical Activity (APA)Supported by an Adapted Physical Activity (APA), at the rate of 3 sessions per week supervised by the association SCO STE MARGUERITE, spread over 12 months |
| Kiné | No intervention | –Standard physiotherapy treatment, at least 20 sessions, renewed at least once, spread over 12 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be between 18 and 60 years old
- Present Axial Spondylitis meeting the criteria of ASAS 2009
- Be on treatment with biotherapy, stable dose for at least 6 months
- Complete the ALD criteria
- Have a BASFI score at inclusion ≤ 5
Key exclusion criteria (5 listed)
- Regularly practice a sports activity (≥ 1hour / week)
- Have a severe handicap limiting the gestures of daily life (dressing, walking, etc ...)
- Have another significant osteo-articular pathology (Rheumatoid arthritis osteoarthritis, hip prosthesis ...)
- Have a bamboo column
- Being pregnant or planning to be pregnant in the coming year
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 |
|---|---|---|
| Adapted Physical Activity (APA)Supported by an Adapted Physical Activity (APA), at the rate of 3 sessions per week supervised by the association SCO STE MARGUERITE, spread over 12 months | Behavioural | Adapted Physical Activity (APA) |
Primary outcome
The mean variation of the BASFI score (Bath Ankylosing Spondylitis Functional Index) over a period of 18 months
Time frame: 18 MONTHS
The primary endpoint is the mean change in BASFI score (functional index of ankylosing spondylitis) between 12 months of management (or M12), and baseline (or M0), compared between the 2 groups. It will be noted BASFI (M12-M0). Patients follow-up will be done during 18 months. BASFI is a self-administered questionnaire that assesses the functional impact of the disease on the patient's life. This tool consists of 10 questions to answer a visual evaluation of 10 cm (0 for "easy" and 10 for "impossible").
9 secondary outcomes
The mean variation of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 18 MONTHS
The mean variation of C-reactive protein (CRP) and sedimentation rate (VS) over a period of 18 months
Time frame: 18 MONTHS
The mean variation of ASDAS (Ankylosing Spondylitis Disease Activity Score).
Time frame: 18 MONTHS
The mean variation of the score of the Visual Analogue Scale of Global Appreciation (EVA-AG) over a period of 18 months.
Time frame: 18 MONTHS
The mean variation in NSAID consumption (Anti-Inflammatory Non Steroidal) over a period of 18 months.
Time frame: 18 MONTHS
The mean variation in the consumption of analgesics.
Time frame: 18 MONTHS
The average variation in medical consumption over a period of 18 months
Time frame: 18 MONTHS
Variation of items in the Patient Questionnaire.
Time frame: 18 MONTHS
The average change in scores on the Quality of Life Questionnaire (short form) SF-12.
Time frame: 18 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity (APA) in people with Ankylosing Spondylitis, run by Hospital St. Joseph, Marseille, France 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 10 inclusion and 5 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 13 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ASSELATE BELKACEM, RESEARCH (0033491807016, basselate@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean variation of the BASFI score (Bath Ankylosing Spondylitis Functional Index) over a period of 18 months (time frame: 18 MONTHS). 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 13 Sep 2019.