Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001169235
Ethics application status
Approved
Date submitted
15/01/2016
Date registered
16/07/2018
Date last updated
16/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
1 year follow-up of Pilates exercises for the management of patients with ankylosing spondylitis
Scientific title
1 year follow-up of Pilates exercises for the management of patients with ankylosing spondylitis
Secondary ID [1] 288327 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ankylosing spondylitis 297295 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297492 297492 0 0
Physiotherapy
Musculoskeletal 307657 307657 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilates exercise program of 1 h was given by a certified physiotherapist to 11 participants 2 times a week for 12 months. Exercise program followed the basic principles of Pilates method but particularly movements with low and medium difficulty levels were chosen to adapt the program to the physical capacity of the patients. Our protocol comprised different modules: postural education, search for neutral position, sitting exercise, antalgic exercises, stretching exercises, proprioceptivity improvement exercises, and breathing education. Resistance bands, foam roller, hoop and 26 cm Pilates balls were used as supportive equipment.
We used a register of attendance at Pilates sessions. The adherence was 92.3% during the year of follow-up.
Intervention code [1] 293620 0
Rehabilitation
Intervention code [2] 301774 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297048 0
Functional capacity

Evaluation was done using the Bath Ankylosing Spondylitis Functional Index (BASFI) for which the adaptation to the native language of the patients has been shown to be valid and reliable .
The BASFI is a set of 10 questions designed to determine the degree of functional limitation in people with AS. The participants were asked to indicate their level of ability with each of the activities during the past week on a horizontal 10 cm line (easy-to-impossible). BASFI score was calculated by dividing the sum of the scores obtained from 10 questions by 10.
Timepoint [1] 297048 0
The Bath Ankylosing Spondylitis Functional Index was performed just before (0-mo), fourth month (4-mo - primary endpoint), eighth month (8-mo) and twelfth month (12-mo) following treatment commencement.
Secondary outcome [1] 319917 0
Disease activity. Evaluation was done using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) comprising a set of 6 questions for which the adaptation to the native language of the patients has been shown to be valid and reliable. This questionnaire includes the entire spectrum of AS symptoms related to fatigue, pain, swelling, and morning stiffness. The patients responded to each item indicating a point on the 10 cm line considering their status during the last week only. Since the items 5 and 6 were both related to morning stiffness, the average score was first calculated between them and then added to the scores of the first 4 items. The final average score, a value between 0 and 10, was found by dividing the total sum by 5.
Timepoint [1] 319917 0
It was performed just before (0-mo), fourth month (4-mo), eighth month (8-mo) and twelfth month (12-mo) following treatment commencement.
Secondary outcome [2] 349255 0
Spinal mobility. Bath Ankylosing Spondylitis Metrology Index (BASMI), which was developed to assess spinal mobility in AS patients, was used. BASMI index was obtained by measuring cervical rotation, tragus to wall distance, lumbar side flexion, modified Schober’s, intermalleolar distance, and scoring the limitations for each criterion between 0 and 10. The final average score, a value between 0 and 10, was found by dividing the total sum by 5.
Timepoint [2] 349255 0
It was performed just before (0-mo), fourth month (4-mo), eighth month (8-mo) and twelfth month (12-mo) following treatment commencement.
Secondary outcome [3] 349256 0
Finger to floor distance. Which is a parameter not included in BASMI, the patient is asked to bend forward and attempt to reach for the floor with their fingertips. We then measured the distance between the patient’s right long finger and the floor using a standard measuring tape.
Timepoint [3] 349256 0
It was performed just before (0-mo), fourth month (4-mo), eighth month (8-mo) and twelfth month (12-mo) following treatment commencement.
Secondary outcome [4] 349257 0
Chest expansion. Which is a parameter not included in BASMI, was evaluated separately by measuring the increase in chest circumference at the level of the fourth intercostal after maximum inspiration following previous forced expiration.
Timepoint [4] 349257 0
It was performed just before (0-mo), fourth month (4-mo), eighth month (8-mo) and twelfth month (12-mo) following treatment commencement.

Eligibility
Key inclusion criteria
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
Presence of any contraindications to the exercises
Wound: not be placed on wounds because bands are not sterile
Severe trauma
General edema (swelling dynamic) caused by heart or kidney problems.
Cancer
Material used allergy.
Pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
1/04/2017
Date of last participant enrolment
Anticipated
Actual
23/06/2017
Date of last data collection
Anticipated
Actual
29/06/2018
Sample size
Target
32
Accrual to date
Final
11
Recruitment outside Australia
Country [1] 7526 0
Spain
State/province [1] 7526 0
Madrid

Funding & Sponsors
Funding source category [1] 292692 0
Other Collaborative groups
Name [1] 292692 0
Association Sick of Ankylosing Spondylitis in Fuenlabrada
Country [1] 292692 0
Spain
Primary sponsor type
Individual
Name
Elena Sonsoles Rodriguez Lopez
Address
Camilo Jose Cela University
Department of Physiotherapy
Castillo de Alarcon Street, 49
28962 Villanueva de la Cañada
Madrid
Country
Spain
Secondary sponsor category [1] 299445 0
None
Name [1] 299445 0
Address [1] 299445 0
Country [1] 299445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294166 0
Camilo Jose Cela University
Ethics committee address [1] 294166 0
Ethics committee country [1] 294166 0
Spain
Date submitted for ethics approval [1] 294166 0
11/01/2017
Approval date [1] 294166 0
16/03/2017
Ethics approval number [1] 294166 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62758 0
Dr Elena Sonsoles Rodriguez Lopez
Address 62758 0
Camilo Jose Cela University
Department of Physiotherapy
Castillo de Alarcon Street, 49
28962 Villanueva de la Cañada
Madrid
Country 62758 0
Spain
Phone 62758 0
+34679336394
Fax 62758 0
Email 62758 0
[email protected]
Contact person for public queries
Name 62759 0
Elena Sonsoles Rodriguez Lopez
Address 62759 0
Camilo Jose Cela University
Department of Physiotherapy
Castillo de Alarcon Street, 49
28962 Villanueva de la Cañada
Madrid
Country 62759 0
Spain
Phone 62759 0
+34679336394
Fax 62759 0
Email 62759 0
[email protected]
Contact person for scientific queries
Name 62760 0
Elena Sonsoles Rodriguez Lopez
Address 62760 0
Camilo Jose Cela University
Department of Physiotherapy
Castillo de Alarcon Street, 49
28962 Villanueva de la Cañada
Madrid
Country 62760 0
Spain
Phone 62760 0
+34679336394
Fax 62760 0
Email 62760 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseOne Year of Pilates Training for Ankylosing Spondylitis: A Pilot Study.2019https://dx.doi.org/10.1089/acm.2018.0405
N.B. These documents automatically identified may not have been verified by the study sponsor.