Condition category
Musculoskeletal Diseases
Date applied
29/09/2011
Date assigned
29/09/2011
Last edited
01/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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 measures

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

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

http://www.keele.ac.uk/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

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.