Benefits of Effective Exercise for knee Pain - The BEEP main trial

ISRCTN ISRCTN93634563
DOI https://doi.org/10.1186/ISRCTN93634563
Secondary identifying numbers 9270
Submission date
29/09/2011
Registration date
29/09/2011
Last edited
11/12/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Stephanie Tooth
Scientific

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Email s.j.tooth@cphc.keele.ac.uk

Study information

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe BEEP study: a trial aiming to improve the effectiveness of physiotherapy-led exercise for knee pain in older adults in primary care
Study acronymBEEP
Study objectivesThis 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(s)First MREC, 09/06/2010, ref:10/H1017/45
Health condition(s) or problem(s) studiedMusculoskeletal, All Diseases
InterventionIndividually 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 typeBehavioural
Primary outcome measurePain 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 measures1. 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 study start date27/10/2010
Completion date30/04/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 7713; UK Sample Size: 7713; Description: 7213 postal and 500 trial (500 screened from 7713 responding to survey).
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment19/11/2010
Date of final enrolment28/02/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Arthritis Research UK Primary Care Centre
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Sponsor information

Keele University (UK)
University/education

Keele
Newcastle-Under-Lyme
ST5 5BG
England
United Kingdom

Website http://www.keele.ac.uk/
ROR logo "ROR" https://ror.org/00340yn33

Funders

Funder type

Government

NIHR - Programme for Applied Research (UK)

No information available

Results and Publications

Intention to publish date31/12/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 27/07/2014 Yes No
Results article results for nested study on ICECAP-A outcome measures 03/03/2016 Yes No
Results article results 01/05/2017 Yes No
Results article results 01/02/2018 Yes No
Results article results 17/02/2018 Yes No
Results article results 01/07/2018 Yes No

Editorial Notes

11/12/2018: Publication reference added.
03/09/2018: Publication reference added.
27/07/2018: Publication reference added.
01/12/2016: Publication reference added.
23/03/2016: Internal review.
22/03/2016: This is the BEEP main study which took place from October 2010 to May 2015. It followed the BEEP pilot study (reference ISRCTN23294263) initially registered in 2010. Both studies have the same intervention and inclusion/exclusion criteria. The outcomes in the main study were pain and function assessed using the WOMAC. The recruitment start date was corrected from 27/10/10 to 19/11/10 and the recruitment end date from 30/04/15 to 28/02/12. At the time of commencing the BEEP main trial, guidance from the ISRCTN registry was that the same registration number should be used as for the pilot trial, but this guidance subsequently changed. Trial registration for the BEEP study started with the pilot study and was finalised in May 2010, before recruitment to the main BEEP trial commenced. The first participants in the main BEEP trial were recruited in November 2010.
04/03/2016: Publication reference added.