Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001343392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
23/06/2026
Date registered
Help: Date registered
9/11/2026
Date last updated
Help: Date last updated
9/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/11/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Diaphragmatic and thoracic manual therapy plus exercise to improve chest expansion in people with ankylosing spondylitis
Scientific title
Effectiveness of diaphragmatic and thoracic manual therapy as an adjunct to a NICE-based multimodal exercise programme on thoracic expansion in patients with ankylosing spondylitis: a multicentre assessor-blinded randomised controlled trial
Additional trial identifiers [1] 317662 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Ankylosing spondylitis 342468 0
Condition category
Condition code
Musculoskeletal 338594 338594 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 340219 340219 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1 (Experimental group): Participants will receive a National Institute for Health and Care Excellence (NICE)-based multimodal exercise programme combined with diaphragmatic and thoracic manual therapy. The exercise programme includes spinal mobility exercises, strengthening exercises, postural exercises, breathing exercises and aerobic walking. Each exercise session will last approximately 30 minutes and will be performed twice weekly for 12 weeks. The exercise programme will be delivered individually and in person under the supervision of the physiotherapist responsible for delivering the manual therapy, who has specific training in therapeutic exercise and experience delivering therapeutic exercise in group classes. The exercise programme will be delivered at health-certified centres belonging to the associations that were contacted for patient recruitment. Attendance will be recorded using an attendance sheet. Manual therapy techniques include diaphragmatic myofascial release, costal diaphragmatic release, phrenic centre inhibition, guided diaphragmatic breathing, passive costovertebral mobilisation, sternal mobilisation and global thoracic mobilisation. Manual therapy sessions will last approximately 25–30 minutes and will be delivered twice weekly for 12 weeks by the same physiotherapist, who has postgraduate training in musculoskeletal manual therapy. The manual therapy sessions will take place at the same health-certified centres belonging to the participating associations.
Intervention code [1] 334491 0
Rehabilitation
Intervention code [2] 334492 0
Treatment: Other
Intervention code [3] 334493 0
Lifestyle
Description of the comparator or control
Participants allocated to the control group will receive a NICE-based multimodal exercise programme including spinal mobility exercises, strengthening exercises, postural exercises, breathing exercises and aerobic walking. Each exercise session will last approximately 30 minutes and will be performed twice weekly for 12 weeks. The programme will be delivered individually and in person under the supervision of the same physiotherapist responsible for delivering the manual therapy in the experimental group. The physiotherapist has specific training in therapeutic exercise and experience delivering therapeutic exercise in group classes, as well as postgraduate training in musculoskeletal manual therapy. The exercise programme will be delivered at health-certified centres belonging to the associations that were contacted for patient recruitment. Attendance will be recorded using an attendance sheet. No diaphragmatic or thoracic manual therapy techniques will be provided.
Control group
Active

Outcomes
Primary outcome [1] 345872 0
Thoracic expansion
Timepoint [1] 345872 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [1] 463573 0
Spinal mobility
Timepoint [1] 463573 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [2] 463574 0
Functional ability
Timepoint [2] 463574 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [3] 463575 0
Ankylosing spondylitis disease activity
Timepoint [3] 463575 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [4] 463576 0
Pain intensity
Timepoint [4] 463576 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [5] 463579 0
Forced vital capacity
Timepoint [5] 463579 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [6] 463580 0
Forced expiratory volume in one second
Timepoint [6] 463580 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [7] 463581 0
Forced expiratory volume in one second to forced vital capacity ratio
Timepoint [7] 463581 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [8] 463584 0
Maximum inspiratory pressure
Timepoint [8] 463584 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [9] 463585 0
Maximum expiratory pressure
Timepoint [9] 463585 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [10] 463586 0
Body mass index
Timepoint [10] 463586 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [11] 463587 0
Fat mass percentage
Timepoint [11] 463587 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [12] 463588 0
Skeletal muscle mass
Timepoint [12] 463588 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [13] 463589 0
Trunk posture
Timepoint [13] 463589 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [14] 463590 0
Fatigue
Timepoint [14] 463590 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [15] 463591 0
Sleep quality
Timepoint [15] 463591 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).
Secondary outcome [16] 463592 0
Health-related quality of life
Timepoint [16] 463592 0
Baseline (before the start of the intervention), week 12 (at the end of the intervention), week 16 (4 weeks post-intervention).

Eligibility
Key inclusion criteria
Adults aged 18–65 years with a confirmed diagnosis of ankylosing spondylitis according to the modified New York criteria, Bath Ankylosing Spondylitis Metrology Index score of 6 or below, clinically stable disease, stable pharmacological treatment including biologic therapy (if applicable) for at least one month prior to enrolment, ability to understand and follow study procedures, and provision of written informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Presence of chronic respiratory disease, severe cardiovascular disease, uncontrolled hypertension, active infection, active malignancy, neurological disorders affecting participation, acute flare of ankylosing spondylitis, recent vertebral fracture, recent thoracic, abdominal or spinal surgery, contraindications to exercise or manual therapy, cognitive impairment limiting the ability to follow study procedures, pregnancy or breastfeeding, participation in another clinical trial during the study period, or initiation or modification of biologic therapy during the intervention period.

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)
Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher not involved in participant recruitment, assessment, treatment or data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence with a 1:1 allocation ratio will be created by an independent researcher using randomisation software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated using G*Power software (version 3.1.9.4) for a mixed repeated-measures analysis of variance, assessing the group by time interaction, considering two groups and three assessment time points (baseline, post-intervention and follow-up). A small-to-moderate effect size of 0.20, a significance level of 0.05, a statistical power of 80 percent, and a correlation among repeated measures of 0.60 were assumed. Under these assumptions, the estimated sample size was 42 participants (21 per group). To account for an anticipated 10 percent dropout rate, the final sample size was increased to 48 participants (24 per group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2027
Actual
Date of last participant enrolment
Anticipated
1/05/2027
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 28242 0
Spain
State/province [1] 28242 0

Funding & Sponsors
Funding source category [1] 322202 0
University
Name [1] 322202 0
Universidad Católica de Ávila
Country [1] 322202 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Country
Spain
Secondary sponsor category [1] 325113 0
None
Name [1] 325113 0
Address [1] 325113 0
Country [1] 325113 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320726 0
Comité de Ética de la Investigación con Medicamentos del Área de Salud de Ávila (CEIm Ávila)
Ethics committee address [1] 320726 0
Ethics committee country [1] 320726 0
Spain
Date submitted for ethics approval [1] 320726 0
16/04/2026
Approval date [1] 320726 0
04/05/2026
Ethics approval number [1] 320726 0
GASAV/2026/12

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

Contacts
Principal investigator
Name 151430 0
Mr Diego Elvira Pérez
Address 151430 0
Bambú blanco, Calle Gredos 10, 2º-2ª, 05002 Ávila, Spain
Country 151430 0
Spain
Phone 151430 0
+34691921675
Fax 151430 0
Email 151430 0
[email protected]
Contact person for public queries
Name 151431 0
Diego Elvira Pérez
Address 151431 0
Bambú Blanco, Calle Gredos 10, 2º-2ª, 05002 Ávila, Spain
Country 151431 0
Spain
Phone 151431 0
+34691921675
Fax 151431 0
Email 151431 0
[email protected]
Contact person for scientific queries
Name 151432 0
Diego Elvira Pérez
Address 151432 0
Bambú Blanco, Calle Gredos 10, 2º-2ª, 05002 Ávila, Spain
Country 151432 0
Spain
Phone 151432 0
+34691921675
Fax 151432 0
Email 151432 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Requests for access to de-identified individual participant data should be submitted by email to the principal investigator, Diego Elvira Pérez, at [email protected]


Are there extra considerations when requesting access to individual participant data?
Yes: Access to de-identified individual participant data will be considered upon reasonable request for scientifically valid research purposes. Requests must include a research proposal and may require approval by the principal investigator. Data sharing will comply with applicable ethical requirements and data protection regulations.




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.