Benefit of Adapted Physical Activity for Patients Suffering From Ankylosing Spondylitis (SPIKE)
Primary Purpose
Ankylosing Spondylitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted Physical Activity (APA)
Sponsored by
About this trial
This is an interventional supportive care trial for Ankylosing Spondylitis
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hopital Saint JosephRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Adapted Physical Activity (APA)
Kiné
Arm Description
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
Standard physiotherapy treatment, at least 20 sessions, renewed at least once, spread over 12 months
Outcomes
Primary Outcome Measures
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").
Secondary Outcome Measures
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.
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.
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)
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.
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.
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
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.
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.
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
Full Information
NCT ID
NCT04089774
First Posted
June 26, 2019
Last Updated
September 12, 2019
Sponsor
Hospital St. Joseph, Marseille, France
1. Study Identification
Unique Protocol Identification Number
NCT04089774
Brief Title
Benefit of Adapted Physical Activity for Patients Suffering From Ankylosing Spondylitis
Acronym
SPIKE
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
June 14, 2022 (Anticipated)
Study Completion Date
June 14, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital St. Joseph, Marseille, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adapted Physical Activity (APA)
Arm Type
Experimental
Arm Description
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
Arm Title
Kiné
Arm Type
No Intervention
Arm Description
Standard physiotherapy treatment, at least 20 sessions, renewed at least once, spread over 12 months
Intervention Type
Behavioral
Intervention Name(s)
Adapted Physical Activity (APA)
Intervention Description
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
Primary Outcome Measure Information:
Title
The mean variation of the BASFI score (Bath Ankylosing Spondylitis Functional Index) over a period of 18 months
Description
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").
Time Frame
18 MONTHS
Secondary Outcome Measure Information:
Title
The mean variation of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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.
Time Frame
18 MONTHS
Title
The mean variation of C-reactive protein (CRP) and sedimentation rate (VS) over a period of 18 months
Description
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.
Time Frame
18 MONTHS
Title
The mean variation of ASDAS (Ankylosing Spondylitis Disease Activity Score).
Description
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)
Time Frame
18 MONTHS
Title
The mean variation of the score of the Visual Analogue Scale of Global Appreciation (EVA-AG) over a period of 18 months.
Description
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.
Time Frame
18 MONTHS
Title
The mean variation in NSAID consumption (Anti-Inflammatory Non Steroidal) over a period of 18 months.
Description
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.
Time Frame
18 MONTHS
Title
The mean variation in the consumption of analgesics.
Description
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
Time Frame
18 MONTHS
Title
The average variation in medical consumption over a period of 18 months
Description
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.
Time Frame
18 MONTHS
Title
Variation of items in the Patient Questionnaire.
Description
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.
Time Frame
18 MONTHS
Title
The average change in scores on the Quality of Life Questionnaire (short form) SF-12.
Description
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
Time Frame
18 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ASSELATE BELKACEM, RESEARCH
Phone
0033491807016
Email
basselate@hopital-saint-joseph.fr
First Name & Middle Initial & Last Name or Official Title & Degree
ASSELATE BELKACEM
Phone
0033491807016
Email
basselate@hopital-saint-joseph.fr
Facility Information:
Facility Name
Hopital Saint Joseph
City
Marseille
State/Province
Bouches DU Rhone
ZIP/Postal Code
13008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ASSELATE BELKACEM
Phone
00491807016
Email
basselate@hopital-saint-joseph.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Benefit of Adapted Physical Activity for Patients Suffering From Ankylosing Spondylitis
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