Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001225707
Ethics application status
Approved
Date submitted
1/04/2021
Date registered
12/09/2022
Date last updated
12/09/2022
Date data sharing statement initially provided
12/09/2022
Date results information initially provided
12/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of complementary interventions in the treatment of Ankylosing Spondylitis
Scientific title
Efficacy of modification of lifestyle in the treatment of Ankylosing Spondylitis: a pilot study
Secondary ID [1] 303857 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:

Ankylosing Spondylitis 321420 0
Quality of life 321421 0
Spinal mobility 321422 0
Limited thoracic expansion 321423 0
Condition category
Condition code
Alternative and Complementary Medicine 319180 319180 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 319181 319181 0 0
Autoimmune diseases
Physical Medicine / Rehabilitation 319183 319183 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Excercise group:
Tabata method that consists of batches of one or more different exercises (high knees, squats, basic burpees, plank or climbers) performed during 8-20 intervals with 10 second interpersed breaks. The excercise will led at home supervised by a physiotherapist. We will achieve two 4-minute sessions per week high intensity workout, the level of intensity was not assessed . The intervention will last 3 months and there were session attendance checklists supervised by a physiotherapist.
Intervention code [1] 320165 0
Lifestyle
Intervention code [2] 324089 0
Rehabilitation
Comparator / control treatment
Probiotic group:
Daily supplementation of a probiotic protocol of bacterial strains during 3 months. The mode of administration is oral tablet. For the first month, the 2 Enterelle capsules will be taken in the morning. For the following two months, participants will switch to 2 Adomelle capsules (Bromatech Laboratories) taken at night.
Note:
- Enterelle capsules (Bromatech Laboratories), with a Composition: Saccharomyces cerevisiae sub. boulardii MTCC-5375 (<1billon CFU), Saccharomyces cerevisiae sub. boulardii SP92 (<1billon CFU) Enterococcus faecium UBEF41 (<1billon CFU) and Lactobacillus acidophilus LA14 (1billon CFU).
- Adomelle capsules (Bromatech Laboratories) with a composition: Lactobacillus plantarum LP115 (<1billon CFU), Bifidobacterium breve B3 (<1billon CFU) and Lactobacillus acidophilus LA14 (1billon CFU).
Control group
Active

Outcomes
Primary outcome [1] 327058 0
Bath Ankylosing Spondylitis functional index (BASFI) , Bath Ankylosing Spondylitis Activity Index (BASDAI) and Metrological index of Bath Ankylosing Spondylitis (BASMI)
Timepoint [1] 327058 0
Measurements were made to the subjects: the first was made one week before the intervention, the second 1 month later (primary timepoint) and a third 3 months after the first measurement. All measurements were made in the morning and fasting, scheduled at the same time.
Secondary outcome [1] 393655 0

Specific questionnaire on quality of life in Ankylosing Spondylitis (ASQoL)
Timepoint [1] 393655 0
Measurements were made to the subjects: the first was made one week before the intervention, the second 1 month later and a third 3 months after the first measurement. All measurements were made in the morning and fasting, scheduled at the same time.

Eligibility
Key inclusion criteria
Patients diagnosed with Ankylosing Spondylitis according to the modified criteria of New York
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any systemic disorder that contraindicates exercise, active peripheral arthritis, total spinal ankylosis, or C-reactive protein (PCR) more than 10 times the normal value. Patients will also be excluded if their treatment has been modified 2 months before the start of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization was performed using a computer generated random sequence in permuted blocks (https://www.randomizer.org). The sequence was obtained by a research assistant who was not involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
23/04/2021
Date of last participant enrolment
Anticipated
Actual
23/04/2021
Date of last data collection
Anticipated
Actual
17/11/2021
Sample size
Target
60
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 24805 0
Spain
State/province [1] 24805 0
Madrid

Funding & Sponsors
Funding source category [1] 308249 0
University
Name [1] 308249 0
Universidad Camilo José Cela
Country [1] 308249 0
Spain
Primary sponsor type
University
Name
Universidad Camilo José Cela
Address
Urb. Villafranca del Castillo
Calle Castillo de Alarcón 49
28692 Villanueva de la Cañada
Madrid
Country
Spain
Secondary sponsor category [1] 309044 0
None
Name [1] 309044 0
Address [1] 309044 0
Country [1] 309044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308232 0
Research Ethics Committee of the Camilo José Cela University.
Ethics committee address [1] 308232 0
Urb. Villafranca del Castillo
Calle Castillo de Alarcón 49
28692 Villanueva de la Cañada
Madrid
Ethics committee country [1] 308232 0
Spain
Date submitted for ethics approval [1] 308232 0
Approval date [1] 308232 0
01/10/2019
Ethics approval number [1] 308232 0

Summary
Brief summary
Ankylosing spondylitis (AS) is a chronic and systemic rheumatic disease that causes inflammation and ankylosis of the axial skeleton. Disease progression often leads to spinal pain, stiffness, strain, deformity, functional impairment, disability and poor quality of life.
From a biological point of view, physical exercise is indicated as a treatment for any chronic pathology and is proposed as a successful complement to the pharmacological treatment of any disease. The gut microbiota can contribute to the metabolic health of the human host and, when abnormal, affects the phenotype of immune cells, increasing the risk of autoimmunity. On the other hand, exercise is a potential modulator of gut microbiome composition and is associated with increased biodiversity and representation of taxa with beneficial metabolic functions. Therefore, we hypothesized that a lifestyle change could improve disease progression (spinal mobility, stiffness, tension, deformity, functional impairment, disability, and poor quality of life).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110006 0
Mr Alvaro Otero Campos
Address 110006 0
Otero Campos
Calle Princesa 22, 4 izq
28008 Madrid, Spain
Country 110006 0
Spain
Phone 110006 0
+34618910140
Fax 110006 0
Email 110006 0
[email protected]
Contact person for public queries
Name 110007 0
Mr Alvaro Otero Campos
Address 110007 0
Clinica Otero Campos
Calle Princesa 22, 4 izq
28008 Madrid, Spain
Country 110007 0
Spain
Phone 110007 0
+34618910140
Fax 110007 0
Email 110007 0
[email protected]
Contact person for scientific queries
Name 110008 0
Mr Alvaro Otero Campos
Address 110008 0
Clinica Otero Campos
Calle Princesa 22, 4 izq
28008 Madrid, Spain
Country 110008 0
Spain
Phone 110008 0
+34618910140
Fax 110008 0
Email 110008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.