Spondylitis, AnkylosingINPACT-ASNCT02374502
Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial
A study testing Brief Intervention in people with Spondylitis, Ankylosing, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2015to Nov 2015
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of ankylosing spondylitis (diagnosed by a rheumatologist).
- Able to read and understand the English language.
- On stable pharmacological management.
Who cannot join
- Under 18 years of age, or over 64 years of age
- Unable to read and understand the English language
- Concomitant cardiac, respiratory or neurological condition
- Co-morbidity restricting physical activity or inability to ambulate without a mobility aid
- Acute lower limb injury
- Uncontrolled epilepsy
Show all 10Show fewer
- Cognitive difficulties limiting ability to follow safety and protocol instructions
- Pregnant
- Change in medication (type of dosage) within six weeks of testing
- On beta-blocker medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial
Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis do not meet physical activity recommendations. This study aims to investigate the effects of a twelve week intervention designed to increase physical activity and exercise in adults with ankylosing spondylitis.
Read the detailed description
Participants will be randomly allocated to one of two groups. An intervention group will receive individual consultations with a physiotherapist. The aim of the meetings will be to motivate and support participants on an individual basis, with the goal of increasing weekly physical activity. The second group, the control group, will continue with their current management strategies. All participants will be assessed at baseline, post-intervention (after twelve weeks) and after a three month follow-up period. The primary outcome measure will be free-living physical activity over one week.
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Brief Intervention
- Keywords
- Spondylarthropathies, Motor Activity, Physical Therapists, Accelerometry
- Medical subject headings
- Spondylitis, Ankylosing, Spondylarthropathies, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems.
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention Group | Experimental | Participants in this intervention group will receive a twelve week 'Brief Intervention' delivered by a physiotherapist. Participants will have an initial consultation with a physiotherapist, followed by a number of follow-up sessions. The number and timing of follow-up sessions will be at the participant's discretion (a minimum of 3 and a maximum of 11 over the duration of the study). The follow-up sessions can be face-to-face, over the telephone, or video conferencing depending on participant preference. Participants may additionally opt-in for a weekly email or text message reminder of physical activity goals. Receives: Behavioral: Brief Intervention |
| Control Group | No intervention | Participants in this control group will be asked to continue with their current levels of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free-living Physical Activity
Actigraph monitor GT3X-BT worn during waking hours over 7 days.
Measured: up to 12 weeks follow-up
Secondary outcomes (10)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Measured: up to 12 weeks follow-up
Bath Ankylosing Spondylitis Functional Index (BASFI)
Measured: up to 12 weeks follow-up
Bath Ankylosing Spondylitis Global score (BAS-G)
Measured: up to 12 weeks follow-up
Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)
Measured: up to 12 weeks follow-up
Cardiorespiratory capacity
VO2peak measured by submaximal, incremental treadmill test
Measured: up to 12 weeks follow-up
Body Composition
Bioelectric impedance analysis \& waist/hip circumference
Measured: up to 12 weeks follow-up
Flexibility
Bath Ankylosing Spondylitis Metrology Index (BASMI) \& Chest Expansion
Measured: up to 12 weeks follow-up
Muscular fitness
Push-up test and curl-up test
Measured: up to 12 weeks follow-up
Exercise Barriers and Beliefs Scale (EBBS)
Measured: up to 12 weeks follow-up
Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)
Measured: up to 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spondylitis, AnkylosingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom O'Dwyer, University of Dublin, Trinity College
- Investigators
- Finbar O'Shea, Principal investigator, St. James's Hospital, IrelandFiona Wilson, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374502
- Sponsor's protocol ID
- REC2015/01/02
- Acronym
- INPACT-AS
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Dwyer T, Monaghan A, Moran J, O'Shea F, Wilson F. Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial. J Physiother. 2017 Jan;63(1):30-39. doi: 10.1016/j.jphys.2016.11.009. Epub 2016 Dec 8.
PubMed 27989730
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02374502
- Acronym / sponsor ID
- INPACT-AS / REC2015/01/02
- Conditions
- Spondylitis, Ankylosing
- Keywords
- Spondylarthropathies, Motor Activity, Physical Therapists, Accelerometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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.
Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis do not meet physical activity recommendations. This study aims to investigate the effects of a twelve week intervention designed to increase physical activity and exercise in adults with ankylosing spondylitis.
Detailed description
Participants will be randomly allocated to one of two groups. An intervention group will receive individual consultations with a physiotherapist. The aim of the meetings will be to motivate and support participants on an individual basis, with the goal of increasing weekly physical activity. The second group, the control group, will continue with their current management strategies. All participants will be assessed at baseline, post-intervention (after twelve weeks) and after a three month follow-up period. The primary outcome measure will be free-living physical activity over one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention Group | Experimental | Behavioral: Brief InterventionParticipants in this intervention group will receive a twelve week 'Brief Intervention' delivered by a physiotherapist. Participants will have an initial consultation with a physiotherapist, followed by a number of follow-up sessions. The number and timing of follow-up sessions will be at the participant's discretion (a minimum of 3 and a maximum of 11 over the duration of the study). The follow-up sessions can be face-to-face, over the telephone, or video conferencing depending on participant preference. Participants may additionally opt-in for a weekly email or text message reminder of physical activity goals. |
| Control Group | No intervention | –Participants in this control group will be asked to continue with their current levels of physical activity. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of ankylosing spondylitis (diagnosed by a rheumatologist).
- Able to read and understand the English language.
- On stable pharmacological management.
Key exclusion criteria (10 listed)
- Under 18 years of age, or over 64 years of age
- Unable to read and understand the English language
- Concomitant cardiac, respiratory or neurological condition
- Co-morbidity restricting physical activity or inability to ambulate without a mobility aid
- Acute lower limb injury
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 |
|---|---|---|
| Brief Intervention'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems. | Behavioural | Brief Intervention Group |
Primary outcome
Free-living Physical Activity
Time frame: up to 12 weeks follow-up
Actigraph monitor GT3X-BT worn during waking hours over 7 days.
10 secondary outcomes
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: up to 12 weeks follow-up
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: up to 12 weeks follow-up
Bath Ankylosing Spondylitis Global score (BAS-G)
Time frame: up to 12 weeks follow-up
Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)
Time frame: up to 12 weeks follow-up
Cardiorespiratory capacity
Time frame: up to 12 weeks follow-up
Body Composition
Time frame: up to 12 weeks follow-up
Flexibility
Time frame: up to 12 weeks follow-up
Muscular fitness
Time frame: up to 12 weeks follow-up
Exercise Barriers and Beliefs Scale (EBBS)
Time frame: up to 12 weeks follow-up
Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)
Time frame: up to 12 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Derived from this study: PubMed 27989730O'Dwyer T, Monaghan A, Moran J, O'Shea F, Wilson F. Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial. J Physiother. 2017 Jan;63(1):30-39. doi: 10.1016/j.jphys.2016.11.009. Epub 2016 Dec 8.
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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.
Finbar O'Shea principal investigator
St. James's Hospital, Ireland
Fiona Wilson principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention in people with Spondylitis, Ankylosing, run by University of Dublin, Trinity College at 1 site in Ireland.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 9 Mar 2016. 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 Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free-living Physical Activity (time frame: up to 12 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374502, which also lists 1 linked publication.
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 9 Mar 2016.