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

ISRCTN	ISRCTN93634563
DOI	https://doi.org/10.1186/ISRCTN93634563
Protocol serial number	9270
Sponsor	Keele University (UK)
Funder	NIHR - Programme for Applied Research (UK)

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

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	BEEP
Study objectives	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(s)	First MREC, 09/06/2010, ref:10/H1017/45
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	500
Key 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
Key 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
Date of first enrolment	19/11/2010
Date of final enrolment	28/02/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Arthritis Research UK Primary Care Centre

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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	27/07/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.