Walk30X5: the development and feasibility evaluation of a physiotherapy walking programme for people with mild to moderate musculoskeletal conditions
| ISRCTN | ISRCTN78581097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78581097 |
| Secondary identifying numbers | Version 1 18th March 2014 |
- Submission date
- 31/03/2014
- Registration date
- 30/07/2014
- Last edited
- 01/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Physical activity is a public health issue. The majority of UK adults fail to meet recommended physical activity levels. People with long-term conditions related to muscles and bones (musculoskeletal) are more likely to be inactive than their peers. Walking is an ideal, popular, exercise and guidelines insist on walking programme development. The aim of this study is to develop and refine an evidence-based, web-based physiotherapy walking programme including podcasts, blog and links. This study will also test the feasibility and acceptability of the programme.
Who can participate?
Adults with a mild/moderate long-term musculoskeletal condition and have been referred locally for physiotherapy assessment.
What does the study involve?
We will first develop the walking programme using information from previous research. Then eligible participants will be randomly allocated to either physiotherapy advice and assessment session, including goal setting, plus one follow-up session or one physiotherapy session to teach the walking programme intervention (progressing up to 3000 steps 5 days a week above what that person could do before the start of the study) and one follow-up. Qualitative interviews of participants (five in each group) and physiotherapists will be taken to understand people's views about the study, the walking programme and physical activity.
What are the possible benefits and risks of participating?
Participants cannot be guaranteed that they will benefit from taking part in the study. There are no expected risks from taking part in the study, although, as usual from taking part in exercise, people may feel slightly short of breath whilst walking and may feel some muscle aching following physical activity.
Where is the study run from?
The Physiotherapy Research Unit at Oxford University Hospitals NHS Trust, UK.
When is the study starting and how long is it expected to run for?
The study starts in July 2014 and is expected to end in June 2016. Recruitment will be between January and June 2015.
Who is funding the study?
The Physiotherapy Research Foundation, UK.
Who is the main contact?
Dr Catherine Minns Lowe
catherine.minnslowe@ouh.nhs.uk
Contact information
Scientific
Physiotherapy Research Unit
Nuffield Orthopaedic Centre
Windmill Rd
Headington
Oxford
OX3 7HE
United Kingdom
| catherine.minnslowe@ouh.nhs.uk |
Study information
| Study design | Development of the intervention via consensus meetings. Feasibility randomised clinical trial with a nested qualitative study to obtain participant's views of the study and walking programme. |
|---|---|
| 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 | Walk30X5: the development and feasibility evaluation of a physiotherapy walking programme for people with mild to moderate musculoskeletal conditions |
| Study acronym | Walk30X5 |
| Study objectives | To develop and refine an evidence-based, web-based physiotherapy walking programme intervention including podcasts, blog and links. To test the feasibility and acceptability of the intervention. |
| Ethics approval(s) | NRES Committee South Central - Oxford B, 25/07/2014, REC ref: 14/SC/1018 |
| Health condition(s) or problem(s) studied | Mild/moderate long-term musculoskeletal conditions affecting back, lower limbs or physical activity levels |
| Intervention | Participants are randomised to Group 1 or 2. Group 1: two physiotherapy sessions. Session 1: participants are asked about their activity levels and advised how they might become more physically active. Participants will set a physical activity goal (e.g., go swimming 2-3 times per week, walk, cycle) for review at follow-up in 8 weeks' time (second session). Participants will return their pedometers, receiving them again before follow-up. Group 2: two physiotherapy sessions. One physiotherapy session following randomisation to teach intervention (progressing up to 3000 steps 5 days a week above individual baseline) and one follow-up. During the initial session the 7-day pedometer values will be used to provide a suitable entry point into the programme and to set step count goals for each participant (a key predictor of increased physical activity [Marshall et al, 2013]). Participants not owning an MP3 player, or concerned about downloading podcasts, will be given an MP3 player with all podcasts installed and ready to go. Participants will be shown the website and podcasts. Any person not having access to a computer will be provided with paper copies of website information. Any obvious barriers to doing the programme (e.g., coping with inclement weather) will be discussed and tips and a plan of action will be provided. |
| Intervention type | Other |
| Primary outcome measure | 6-minute timed walk test. Timepoints for all outcomes: baseline, 3 months (post-intervention) and 6 months. |
| Secondary outcome measures | 1. 7-day mean step count using an Omron HJ-720ITC pedometer 2. Blood pressure 3. Peak flow 4. The British Heart Foundation's Daily Activities Questionnaire will be used to measure the amount of physical activity people have engaged in during the previous 7 days 5. Visual analogue scales will measure pain intensity, average pain and fatigue 6. The Positive and Negative Affect Schedule (PANAS) self-report measure will be used to measure positive and negative affect 7. A single question about happiness will be used from the SF-36 (short-form health survey) 8. Self-efficacy will be measured by the Generalised Self-Efficacy scale 9. A self-report exercise diary will be used to provide information about adherence to the intervention 10. Quality of life will be assessed using the EQ-5D-5L and a global health rating question will be included 11. EQ-5D-5L and resource use diaries will be used to provide data regarding health economics 12. Participants will be asked to report adverse events, including falls Timepoints for all outcomes: baseline, 3 months (post-intervention) and 6 months. |
| Overall study start date | 01/07/2014 |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 participants for feasibility trial |
| Total final enrolment | 41 |
| Key inclusion criteria | 1. Patients referred for physiotherapy assessment and advice by GPs for any mild/moderate/none severe musculoskeletal conditions effecting physical activity (e.g., chronic back pain, fibromyalgia, lower limb arthritis) with pain (rated 4 or above on a visual analogue scale) lasting at least 3 months, and considered physically able to undertake the programme 2. Participants self-reporting < 120 mins (4 x 30 min) of moderate intensity exercise a week 3. Participants able to perform 6-minute timed walk test (own pace, no walking aid) with non-severe reports of pain (equal or less than 6/10 on the VAS scale) during screening 4. Participant is willing and able to give informed consent for participation in the study. Patient is fluent in English and able to read screens 5. Male or female, aged 18 years or above |
| Key exclusion criteria | 1. Participants scoring an average pain VAS > 6 on walk test 2. Participants unable/unwilling to provide consent 3. Participants with a recent history of an illness likely to interfere with the ability to undertake the programme safely: serious cardiac or respiratory diagnoses, lower limb fractures (last 12 months), blindness, systemic illness, those reporting that a doctor had told them not to exercise 4. Pregnancy 5. Unable to participate in the intervention |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 01/06/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX3 7HE
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Oxford University Hospitals NHS Trust
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
England
United Kingdom
| Website | http://www.ouh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2020 | 01/10/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/10/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
