Plain English Summary
Background and study aims
Knee pain in older adults is a common disabling problem, managed in the UK mostly in primary care (GPs). Approximately 25% of those aged over 55 years are affected at any one time and half will find some daily activities more difficult. Knee pain in older adults is often due to osteoarthritis (OA). Given the ageing population the problem is set to get worse, and the need for effective treatment approaches is clear. Recent national and international guidelines as well as studies show that exercise can help in knee and hip OA. Exercise improves muscle dysfunction and reduces pain and disability without exacerbating joint damage. It can reduce the risk of other chronic conditions and improve the physical status of people with OA. However, there is a lack of evidence around the practical aspects of exercise delivery and maintenance, including what is an appropriate “dose” of exercise and how to support individuals to continue to exercise in the longer-term. Physiotherapists are the largest group of exercise advisor's for musculoskeletal problems in the NHS and are therefore an appropriate group with which to develop and test strategies. The aim of this study is to assess first whether helping people with knee pain to find the right exercise routine and maintaining it over time will produce better results. It is the continuation of a smaller study done with a smaller number of participants.
Who can participate?
Adults over 45 years old with knee pain and referred by their doctor.
What does the study involve?
All participants receive the same advice and information (booklet) and a home exercise programme. They are then allocated to one of three groups. The usual care group (Group 1) receive up to 4 face-to face treatment sessions within 12 weeks with the physiotherapist. The Individually Tailored Exercise group (Group 2) receive between 6 to 8 face-to-face treatment sessions within 12 weeks with the physiotherapist. The Targeted Exercise Adherence group (Group 3) receive 4 treatment sessions within 12 weeks, plus between 6 to 8 face-to-face treatment sessions within 12 weeks with the physiotherapist
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Keele University Primary Care Musculoskeletal Research Centre, UK
When is the study starting and how long is it expected to run for?
October 2010 to May 2015
Who is funding the study?
National Institute for Health Research (NIHR), UK
Who is the main contact?
Ms Stephanie Tooth
Ms Nadine Foster
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Stephanie Tooth
ORCID ID
Contact details
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
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s.j.tooth@cphc.keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9270
Study information
Scientific title
The BEEP study: a trial aiming to improve the effectiveness of physiotherapy-led exercise for knee pain in older adults in primary care
Acronym
BEEP
Study hypothesis
This is a randomised controlled trial investigating whether helping people with knee pain to find the right exercise routine and maintaining it over time results in better outcomes.
The main aim of the study is to determine the clinical cost-effectiveness of the two physiotherapy-led exercise interventions to improve individual tailoring of adherence to exercise in known osteoarthritis (OA) patients in primary care, in comparison to usual physiotherapy care with nested qualitative interviews.
Ethics approval
First MREC, 09/06/2010, ref:10/H1017/45
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Musculoskeletal, All Diseases
Intervention
Individually Tailored Exercise
Patients will receive between 6-8 face-to-face treatment sessions with a physiotherapist within 12 weeks
Targeted Exercise Adherence Group
Patients will receive 4 treatment sessions within 12 weeks, plus between 4 to 6 additional contacts with the physiotherapist from week 12 to month 6
Usual Care
Patients will receive up to 4 face-to-face treatment sessions within 12 weeks with a physiotherapist
Follow Up Length: 36 month(s); Study Entry : Registration and One or More Randomisations
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Pain and Function from the WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
WOMAC is collected at baseline, 3, 6, 9, 18 and 36 months
Secondary outcome measures
1. 7-day accelerometry; Timepoint(s): Collected at baseline, 3, 6, 9, 18 and 36 months
2. Anxiety (GAD-7); Timepoint(s): Collected at baseline, 3, 6, 9, 18 and 36 months
3. Body Mass Index; Timepoint(s): Collected at baseline, 3, 6, 9, 18 and 36 months
4. Cost-effectiveness; Timepoint(s): Collected at 3, 6, 9, 18 and 36 months
5. Depression (PHG-8); Timepoint(s): Collected at baseline, 3, 6, 9, 18 and 36 months
6. Exercise adherence; Timepoint(s): Collected at 3, 6, 9, 18 and 36 months
7. Healthcare utilisation (self report & Med Rec Review); Timepoint(s): Collected at 6, 18 and 36 months
8. ICE CAP-A capabilities; Timepoint(s): Collected at baseline, 6 and 18 months
9. Illness Perceptions (IPQ); Timepoint(s): Collected at baseline, 3 and 6 months
10. Medication usage; Timepoint(s): Collected at baseline, 3, 6, 9, 18 months
11. OMERACT-OARSI; Timepoint(s): Collected at baseline, 3, 6, 9, 18 and 36 months
12. Overall health status (EQ-SD); Timepoint(s): Collected at baseline, 3, 6, 9, 18 and 36 months
13. Patient's Global Assessment of Change; Timepoint(s): Collected at 3, 6, 9, 18 and 36 months
14. Physical activity levels (self report PASE); Timepoint(s): Collected at baseline, 3, 6, 9, 18 and 36 months
15. Self-efficacy for exercise (SEE); Timepoint(s): Collected at baseline, 3 and 6 months
Overall trial start date
27/10/2010
Overall trial end date
30/04/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 45 years and over
2. Knee pain or stiffness in one or both knees
3. Primary care consulters willing to particpate in the study
4. Able to give informed consent
5. Has access to telephone
6. Able to read and write in English
7. Target Gender: Male & Female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 7713; UK Sample Size: 7713; Description: 7213 postal and 500 trial (500 screened from 7713 responding to survey).
Participant exclusion criteria
1. Those with potentially serious pathology
2. Those on a waiting list to have a hip or knee replacement to affected side
3. Those who have already had a hip or knee replacement to affected side
4. When the knee problem is caused by a recent sports injury, fall or accident
5. Those for whom exercise interventions are contra-indicated
6. Those who have had an exercise programme from a physiotherapist, or an injection in the last 3 months
7. Those living in a nursing home
Recruitment start date
19/11/2010
Recruitment end date
28/02/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Arthritis Research UK Primary Care Centre
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
Sponsor information
Organisation
Keele University (UK)
Sponsor details
Keele
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR - Programme for Applied Research (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
31/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25064573
2016 results for nested study on ICECAP-A outcome measures in: http://www.ncbi.nlm.nih.gov/pubmed/26940027
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27894731
Publication citations
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Protocol
Foster NE, Healey EL, Holden MA, Nicholls E, Whitehurst DG, Jowett S, Jinks C, Roddy E, Hay EM, , A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563)., BMC Musculoskelet Disord, 2014, 15, 254, doi: 10.1186/1471-2474-15-254.
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Results
An analysis of the complementarity of ICECAP-A and EQ-5D-3 L in an adult population of patients with knee pain, Health and Quality of Life Outcomes, 2016, 14, 1, 36 , doi: 10.1186/s12955-016-0430-x.