Increasing physical activity in older people with chronic pain
| ISRCTN | ISRCTN10158028 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10158028 |
| Secondary identifying numbers | 20117 |
- Submission date
- 20/01/2016
- Registration date
- 20/01/2016
- Last edited
- 28/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Chronic (long-term) pain is any pain that has lasted for more than 12 weeks. As we get older, it is particularly common to experience pain in muscles and joints (musculoskeletal pain), especially in the over 65s age group. Studies have shown that when a person is in pain, they are likely to avoid movement and physical activity which could make their pain worse. This has led to many people over the age of 65 becoming very inactive. The benefits of exercise on the body are well documented, and so it is important to encourage older people to be more active. An acceptable form of exercise which does not put too much strain on the body is walking. iPOPP (increasing physical activity in older people) is a new programme which has been developed to encourage older people to walk more. It involves face-to-face appointments with specially trained health care assistants (HCAs) as well as the delivery of motivational messages to encourage people to continue with the programme. The aim of this study is to find out whether the iPOPP programme is an effective way of improving physical activity in older people suffering from chronic pain.
Who can participate?
Adults aged 65 or over who have seen their GP about musculoskeletal pain in the last 12 months.
What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the first group (control group) continue to receive usual care, such as seeing their GP, taking medication and receiving treatment (i.e. physiotherapy) and are also posted a copy of the pain toolkit (a simple booklet which provides tips and skills to help people to manage their chronic pain). Participants in the second group continue to receive their usual care, but are also given two appointments with a trained HCA. At the first appointment, they are given a pedometer and user guide, a walking diary (to record how much they are walking) and a copy of the pain toolkit and at the second appointment (by telephone) they are asked for feedback about how much they are walking. Participants also receive motivational messages every week for 8 weeks in the form of a postcard, email or text, to encourage them to maintain their walking plan. Participants in the third group receive the pedometer, user guide, walking diary and pain toolkit in the post, as well as continuing to receive their usual care.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Arthritis Research UK Primary Care Centre (UK)
When is the study starting and how long is it expected to run for?
December 2015 to May 2016
Who is funding the study?
Arthritis Research UK (UK)
Who is the main contact?
Ms Jacqueline Gray
Contact information
Public
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Increasing Physical activity in Older People with chronic musculoskeletal Pain: A brief and simple intervention to promote walking |
| Study acronym | iPOPP |
| Study objectives | The aim of this study is to find out whether a brief and simple intervention to promote walking can be delivered by Health Care Assistants (HCAs) and is acceptable to patients suffering with chronic musculoskeletal pain. |
| Ethics approval(s) | 15/WM/0329 |
| Health condition(s) or problem(s) studied | Topic: Primary Care, Musculoskeletal disorders, Ageing; Subtopic: Musculoskeletal (all Subtopics), Ageing, Primary care; Disease: Musculoskeletal, All Diseases, All Ageing |
| Intervention | Participants are randomly allocated to one of three study arms. Control arm: Participants will continue to be managed via usual care but will be posted a copy of the pain toolkit, which is a simple information booklet that provides patients with tips and skills to support them to manage their chronic pain. Usual primary care management normally consists of a patient consulting their GP or practice nurse for their pain and may include advice and education, the prescription of medication and referrals to other appropriate services i.e. physiotherapy, podiatry, occupational therapy. iPOPP arm: Participants will be offered an initial appointment for a face-to-face consultation at their general practice with a trained HCA. At this initial consultation patients will receive a pedometer, the user guide and walking diary (as above) plus a copy of the pain toolkit. Participants will receive a second consultation either face-to-face or via telephone (depending on participant preference) consisting of a review of progress since session one, positive feedback in relation to effort and achievement, and possible revision of goals set. Participants will then receive the 8 weekly motivational prompts which will be in the form of a postcard, email or text. The type of prompt will be based on individual patient preference. Patients allocated to this intervention arm will also continue to be able to access usual care. Pedometer arm: Participants will receive a pedometer, a pedometer user guide, a walking diary and the pain toolkit in the post. In addition, these patients will continue to be able to access usual care. |
| Intervention type | Other |
| Primary outcome measure | Acceptability and feasibility of training the HCAs and delivery of the iPOPP intervention. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 08/12/2015 |
| Completion date | 05/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 150; UK Sample Size: 150 |
| Total final enrolment | 160 |
| Key inclusion criteria | 1. Adults aged 65 years and over 2. Consulted at their general practice for musculoskeletal pain in one or more index sites (foot, knee, hip, back, shoulder or neck) in the last 12 months 3. Registered with one of the participating GP practices during the specified trial period for that practice 4. Chronic Pain Grade score of between 2 to 4, determined through a brief postal chronic pain screening survey 5. Able to provide full, informed, written consent |
| Key exclusion criteria | 1. Traumatic injury related pain (recent sports injury, fall or accident) to rule out traumatic fractures 2. Patients with complex medical conditions deemed at risk of exerciserelated complications by their GP (e.g. chest pain on exertion, severe hypertension, congestive heart failure, syncope, uncontrolled epilepsy, recent fracture, active and severe synovitis) 3. Vulnerable patients (i.e. patients with significant cognitive impairment (e.g. dementia), or in palliative stage of care) 4. Patients who reside in a residential or nursing home |
| Date of first enrolment | 08/12/2015 |
| Date of final enrolment | 30/05/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
Sponsor information
University/education
Keele
Newcastle
ST5 5BG
England
United Kingdom
"ROR" |
https://ror.org/00340yn33 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from primarycare.datasharing@keele.ac.uk. Core data will be available immediately after main publication. A data request form is required to be completed and must outline the type of data to be obtained, the reason for obtaining this data (research question/objective), the timing for when the data is required to be available (start date/end date). Checks will be performed by a Data Custodian and Academic Proposals (DCAP) committee at Keele to ensure that the data set requested is appropriately suited to answer the research question/objective and that the request fits with the original ethical approval and participant consent and adheres to funder and legal restrictions. Only de-identified data are available for request in aggregated format or at the level of the individual participant. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/03/2018 | 14/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
28/06/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/05/2016 to 05/01/2017.
2. The intention to publish date has been added.
14/05/2021: The following changes have been made:
1. The final enrolment number has been added.
2. Publication reference added.
3. The publication and dissemination plan has been added.
4. The IPD sharing statement and participant level data availability have been added.
26/07/2017: Internal review.
