- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07414823
Walking Football for Axial Spondyloarthritis (KICK START AS)
Walking Football and Axial Spondyloarthritis: Assessing Feasibility, Safety and Patient Reported Outcomes
Axial spondyloarthritis (axSpA) is a long-term inflammatory condition affecting the spine. Patients with this condition can have pain and stiffness in their back and neck. NICE Guidelines recommend that these patients should follow a structured exercise programme with additional hydrotherapy, to maintain mobility and flexibility, so as to improve quality of life.
While there is limited hydrotherapy provided in Portsmouth to approximately 40 axSpA patients via the National Axial Spondyloarthritis Society (NASS), there is no bespoke structured exercise programme for over 400 axSpA patients under the care of the Rheumatology Department, other than exercise advice which patients are asked to follow in their own time.
We propose twice-weekly Walking Football sessions for our axSpA patients as a structured exercise programme. Walking Football is an inclusive sport, with proven health benefits to other patient groups. Unlike traditional football, walking football is a non-contact sport; players are not allowed to run or jump, and the ball must stay below head height. In this way, people with some mobility impairment or mild frailty can still play. In addition to getting regular physical exercise, twice-weekly sessions would provide training in a sporting skill, as well as give opportunities to connect with other players socially, providing mental health benefits.
We have a number of axSpA patients who are keen to try Walking Football as part of their axSpA management, but there is a lack of evidence on the safety and effectiveness of this. We thus plan to undertake a 12-week pragmatic feasibility study to gather this evidence.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
NICE guidelines recommend structured exercise programme as the non-pharmacological management of Axial Spondyloarthritis (axSpA), with hydrotherapy to be considered as adjunctive therapy. While limited hydrotherapy is provided at our hospital via the National Axial Spondyloarthritis Society (NASS) for some of our patients, there is a gap in the provision of structured exercise programme for axSpA patients in our community. We propose to offer Walking Football to fill this gap.
Walking Football is an inclusive sport, accommodating those with mild mobility impairments, as no jumping or running is allowed, and the ball in play is not permitted to exceed players' head-height. It could be an ideal form of exercise for axSpA patients, whose treatment goal is to maintain mobility in order to maximise quality of life. While the hydrotherapy currently offered helps to maintain joint flexibility and range of movement, Walking Football provides weight-bearing exercise which is key to maintaining bone health. Furthermore, the proposed Walking Football sessions will be led by exercise and football coaches, building on recent findings (van Wissen et al, 2024) that longstanding supervised exercise therapy was more effective in axSpA patients than usual care.
We have a group of axSpA patients who are interested in using Walking Football as part of their axSpA management, but there is a lack of literature on the safety and effectiveness of this. We thus plan to design and undertake a pragmatic feasibility study.
OBJECTIVES:
- To assess safety of Walking Football in players with axSpA
- To assess objective as well as patient-reported outcomes of a Walking Football intervention, including disease burden measures
- To assess feasibility of providing Walking Football in our community
- To maximise Patient and Public Involvement (PPI), gather information to inform a larger pilot/RCT
PLANNED OUTPUTS:
- Quantitative results showing effects of Walking Football on axSpA patients
- Qualitative results showing effects of Walking Football on patients' quality of life, and patient feedback on the intervention
- Academic publication, presentation at professional conference
IMPLEMENTATION:
Pompey in the Community (PitC), the charitable arm of Portsmouth Football Club, has agreed to run a 12-week programme of Walking Football at a local stadium, for up to 20 of our axSpA patients. This will be twice-weekly hour-long sessions, to be led by experienced exercise and football coaches. We intend to run clinical assessments (including MASES and BASMI) as well as self-reported disease burden surveys (including ASQoL, AS-WIS, HADS, BASFI, BASDAI, BAS-G, VAS, WASTEd scores) of each participant prior to, at the mid-point and after the end of this intervention.
Using our team's connection with axSpA patients via NASS and our Physiotherapy service, we will involve patients and relevant members of the community in PPI activities, to facilitate the qualitative elements of our research, including patient interviews and focus groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Portsmouth, United Kingdom
- Portsmouth Hospitals University NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Has a formal diagnosis of axial spondyloarthritis, as stated in existing clinical documents
- Able to walk independently without walking aids (note: there will be no upper age limit)
- Good understanding of spoken and written English
Exclusion Criteria:
- Under 18 years of age
- Significant disability affecting ability to play walking football
- Inability to commit to at least 18 of the 24 planned sessions of walking football
- Already a regular participant in local walking football sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feasibility study
Twice-weekly hourlong walking football sessions
|
Walking football is a non-contact 5- to 7-a-side game, lower-impact on joints than standard football as no running or jumping is permitted.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical measurement and standardised disease burden questionnaires
Time Frame: 12 weeks
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Clinical assessments including biometric data, MASES and BASMI scores, 6-minute walk test, sit-to-stand test, and injury surveillance reporting. Participant self-reported disease outcome and quality of life questionnaires including ASQoL, AS-WIS, HADS, BASFI, BASDAI, BAS-G, VAS, WASTEd and loneliness scale. All of the above clinical assessments, tests, as well as qualitative results will combine to determine whether Walking Football is/isn't a safe and beneficial form of exercise for axSpA patients. |
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHU-2025/33
- 359266 (Other Identifier: Integrated Research Application System (IRAS), UK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of BonnNovartis; Novartis PharmaceuticalsRecruitingAxial Spondyloarthritis | Axial and Peripheral Spondyloarthritis | Axial Spondyloarthopathy | Axial Spondyloarthritis and Ankylosing Spondylitis | Axial Spondyloarthritis (AxSpA) | Axial Spondylarthritis (r-axSpA) | Axial Spondyloarthritis, Non-RadiographicGermany
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UCB Biopharma SRLCompletedNonradiographic Axial SpondyloarthritisUnited States, Belgium, Bulgaria, China, Czechia, France, Germany, Hungary, Japan, Poland, Spain, United Kingdom, Turkey (Türkiye)
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Novartis PharmaceuticalsActive, not recruitingNon-radiographic Axial SpondyloarthritisItaly, Germany, Thailand, Israel, Belgium, France, Hungary, Malaysia, Poland, Philippines, Colombia, Mexico, Romania, Czechia, Brazil, Netherlands, Vietnam, Turkey (Türkiye)
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Sunshine Guojian Pharmaceutical (Shanghai) Co.,...RecruitingAxial SpondyloarthritisChina
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Merck Sharp & Dohme LLCCompletedSpondyloarthritisCzechia, Germany, Netherlands, Poland, Romania, Russian Federation, Spain, Turkey, Ukraine
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Novartis PharmaceuticalsCompletedNon-radiographic Axial SpondyloarthritisChina
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