Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Catherine Minns Lowe
ORCID ID
Contact details
Physiotherapy Research Unit
Nuffield Orthopaedic Centre
Windmill Rd
Headington
Oxford
OX3 7HE
United Kingdom
-
catherine.minnslowe@ouh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1 18th March 2014
Study information
Scientific title
Walk30X5: the development and feasibility evaluation of a physiotherapy walking programme for people with mild to moderate musculoskeletal conditions
Acronym
Walk30X5
Study hypothesis
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
NRES Committee South Central - Oxford B, 25/07/2014, REC ref: 14/SC/1018
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
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2014
Overall trial end date
30/06/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 participants for feasibility trial
Participant 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
Recruitment start date
01/01/2015
Recruitment end date
01/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Orthopaedic Centre
Oxford
OX3 7HE
United Kingdom
Sponsor information
Organisation
Oxford University Hospitals NHS Trust (UK)
Sponsor details
Research and Development Department
Oxford University Hospitals NHS Trust
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Chartered Society of Physiotherapy (CSP) Charitable Trust (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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary