Getting an education and exercise programme for older adults with neurogenic claudication (the BOOST programme) into clinical practice: a research study.
| ISRCTN | ISRCTN14563684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14563684 |
| IRAS number | 315731 |
| Secondary identifying numbers | CPMS 53283, NIHR203301, IRAS 315731 |
- Submission date
- 24/10/2022
- Registration date
- 07/11/2022
- Last edited
- 09/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
A recent randomised controlled trial found the BOOST programme significantly improved walking ability and reduced falls risk at 12 months in people with symptomatic lumbar spinal stenosis (LSS). Spinal stenosis happens when the space inside the backbone is too small. This can put pressure on the spinal cord and nerves that travel through the spine. The programme consisted of an individual session and 12 group-based sessions of education and exercise. Before widespread implementation of the BOOST programme, we want to optimise it to achieve maximum effectiveness on clinical outcomes and uptake by healthcare providers. We have formed a ‘community of practice’ with patients and health professionals to provide feedback on the original programme and to iteratively coproduce content for optimisation.
Who can participate?
Patients aged 65 years or older, with symptomatic LSS, and health professionals and exercise therapists aged 21 years or older, providing treatment for symptomatic LSS.
What does the study involve?
This protocol describes two sequential observational studies with embedded interview studies. The first study aims to evaluate the clinical effectiveness of the optimised BOOST programme. To do this, we will collect data from patients before they start the optimised BOOST programme and in six months’ time. We will measure pain-related disability, quality of life, walking capacity, and satisfaction. We will interview the health professionals delivering the optimised programme to understand their experiences. Data from the first study will inform the wider implementation in stage two.
In stage two, we will develop a digital resource to provide health professionals with knowledge, skills, and tools to implement the BOOST programme. We will evaluate learning and implementation outcomes to ensure the digital resource is effective. For a subset of health professionals delivering BOOST to patients, we will collect the same patient data (pain-related disability, quality of life, walking capacity, and satisfaction) at baseline and six months. Health professionals, or level four exercise therapists, treating people with LSS can take part in the digital resource evaluation. Patients taking part in the clinical evaluation will have been referred for NHS physiotherapy and have symptoms of LSS. The BOOST programme can be delivered in an NHS or community setting, in partnership with an NHS Trust.
What are the possible benefits and risks of participating?
The advice, information, and exercises received as part of the BOOST programme may help patients back and leg symptoms. In the multi-centre trial that evaluated the BOOST programme, patients significantly improved their waking capacity and physical function, and reduced their falls risk by 40% compared to usual care.
Patients are unlikely to be harmed by the BOOST programme. The therapist will have assessed the patient to make sure that the exercises are at the right level for them. However, participants may experience normal muscle soreness after completing some of the exercises. This is expected and the therapist will provide participants with advice on how to manage this.
Where is the study run from?
University of Exeter (UK)
When is the study starting and how long is it expected to run for?
May 2022 to January 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Cynthia Srikesavan, c.srikesavan2@exeter.ac.uk
Contact information
Scientific
Faculty of Health and Life Sciences
University of Exeter
Exeter
EX4 6TL
United Kingdom
| Phone | +44 1392 722370 |
|---|---|
| c.srikesavan2@exeter.ac.uk |
Study information
| Study design | Inteverntional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Evaluating the optimisation and impact of the BOOST programme: an implementation study |
| Study acronym | BOOST-IS v1.0 |
| Study objectives | We can optimize outcomes for people with neurogenic claudication in a real-world setting, achieving outcomes equal to those achieved in the context of a multi-centered clinical trial. |
| Ethics approval(s) | Approved 26/07/2022, London - Surrey Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 2071048388; surrey.rec@hra.nhs.uk), ref: 22/PR/0776 |
| Health condition(s) or problem(s) studied | Symptomatic lumbar spinal stenosis |
| Intervention | The BOOST programme has been published in detail and is described in brief below. Dose and method: BOOST is predominantly a group-based intervention. It consists of one 60-minute individual session followed by 12 x 90-minute group sessions over 12 weeks. Participants complete a home exercise programme twice weekly during and beyond the formal programme. At 1 and 2 months after completion of the formal programme, participants receive a support phone call. Provider: Each session is delivered by a therapist who has specific training in the BOOST programme. For stage 1, this training will be delivered face-to-face where possible. For stage 2, this training will be solely via the BOOST online training platform. Initial individual session: Participants receive: • Provision of advice on diagnosis and prognosis. • Individually tailored exercises to complete in the group sessions. • Provision of a patient workbook containing education and exercises. Group session content: Each group session consists of 30 minutes of education and discussion based on a CBA, followed by 60 minutes of exercise. The exercise component includes: • Seated warm-up. • Individually tailored strength, balance, and flexibility exercises. • A 20-minute supervised walking programme. Optimisation We have optimised the BOOST programme to improve its effect on pain-related disability and to maximise conversion to long term exercise/activity. We have iteratively co-produced these enhancements with our community of practice consisting of patients and physiotherapists. Enhancements to the programme include: • Addition of an upper quadrant exercise in standing. • Delivering the BOOST programme in partnership with the voluntary, community, and social enterprise sector (VCSE). Sites will have the flexibility to decide how they partner with the VCSE, for example, some may choose to provide a consulting role while the BOOST programme itself is delivered by an accredited and trained community provider, while others may choose to invite a community provider to one of the BOOST sessions to provide awareness of suitable local activities running in the community. • Enhancing education on the management of pain flare ups and on managing symptoms when standing. • Engaging with a clinical pharmacist to provide more detailed education on medication and improve awareness that patients can request medication reviews from their clinical pharmacist without the need for a GP appointment. • Offering the patient workbook digitally. • Providing participants with a ‘business card’ containing education about their condition with exercise recommendations. |
| Intervention type | Behavioural |
| Primary outcome measure | Walking capacity is measured using the patient-reported Oswestry Disability Index (ODI) walking item and the objective 6 minute walk test at baseline and at 6 months |
| Secondary outcome measures | 1. Pain related disability is measured by the ODI at baseline and at 6 months 2. Health related quality of life is measured by the EQ-5D-5L at baseline and at 6 months 3. Troublesomeness is measured using a single item measuring how troublesome back and leg symptoms have been over the past 4 weeks at baseline and at 6 months 4. Satisfaction is measured at 6 months 5. Physical activity is measured using 4 items from the physical activity and sedentary behaviour questionnaire (CSEP-PATH) at baseline and at 6 months 6. Activity measured from a wrist worn accelerometer will be measured over 16-days at baseline and at 6 months 7. Sleep efficacy will be measured from a wrist worn accelerometer will be measured over 16-days at baseline and at 6 months |
| Overall study start date | 02/05/2022 |
| Completion date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 114; UK Sample Size: 114 |
| Total final enrolment | 142 |
| Key inclusion criteria | Patient participants: 1. Able to give informed consent 2. Aged 65 years and over 3. Symptoms consistent with symptomatic lumbar spinal stenosis: 3.1. A report of back pain and/or pain or other symptoms such as tingling, numbness or heaviness that travels from their back into their buttocks or legs in the last 6 weeks. 3.2. Standing or walking makes symptoms in the buttocks or legs worse. 3.3. Sitting or bending forward relieves symptoms. Therapist participants: 1. Be either a qualified a health professional or a level 4 exercise therapist. 2. Provide treatment (or plan to provide treatment in the near future) to patients with symptomatic lumbar spinal stenosis. 3. Be based in the UK. 4. Employed by either the NHS or a community health provider (depending on local business models, exercise therapists can be self-employed if they are providing services for a community provider). 5. Aged 21 years and over. |
| Key exclusion criteria | Patient participants: 1. Nursing home resident. 2. Inability to walk 3 meters independently. 3. Awaiting surgery. 4. Cauda equina syndrome or signs of serious pathology. 5. Cognitive impairment (defined as a score of 6 or lower on the Abbreviated Mental Test score.) 6. Registered blind. 7. Unable to follow instructions in a group setting. Therapist participants: Not meeting the inclusion criteria. |
| Date of first enrolment | 08/08/2022 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Holt Street
Birmingham Science Park, Aston
Birmingham
B7 4BN
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
8 Victoria Road
Leeds
LS6 1PF
United Kingdom
John Charles Centre for Sport
Middleton Grove
Leeds
LS11 5DJ
United Kingdom
Caerleon
Newport
NP18 3XQ
United Kingdom
Sponsor information
University/education
Stocker Road
Exeter
EX4 4PY
England
United Kingdom
| Phone | +44 1392 723588 |
|---|---|
| P.R.Baxter2@exeter.ac.uk | |
| Website | http://www.exeter.ac.uk/ |
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | At the end of the study and once all analyses are complete, data will be uploaded into the University of Exeter's institutional repository, Open Research Exeter (ORE), which stores and preserves research data securely for the long-term. Data will not be publicly available, but anyone interested in accessing the data can request access from the chief investigator (Professor Sallie Lamb, s.e.lamb@exeter.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 15/07/2022 | 07/11/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | 09/06/2025 | No | No |
Additional files
Editorial Notes
09/06/2025: A file of unpublished summary findings was uploaded as an additional file.
14/05/2024: Contact details updated.
11/10/2024: The total final enrolment was added.
12/05/2023: The recruitment end date was changed from 31/05/2023 to 30/06/2023.
26/04/2023: The recruitment end date was changed from 30/04/2023 to 31/05/2023.
15/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 30/04/2023.
2. The overall trial end date was changed from 31/08/2023 to 31/01/2024.
24/10/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
