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Table 1 Description of the intervention using the Template for Intervention Description and Replication (TIDieR) Checklist

From: The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial

1. Brief name

The Physical Activity for Back Pain (PAyBack) trial

2. Why?

Low back pain (LBP) is one of the most disabling conditions imposing an enormous economic burden to society and individuals. Although physical activity and exercise are effective in reducing pain and disability in patients with chronic LBP, these improvements are at best moderate and not sustained over the long term. Furthermore, physical activity-based interventions are not effective for increasing physical activity levels of patients with chronic musculoskeletal pain. We would argue that current interventions are not designed to change patients’ behaviour toward an active lifestyle

3. What materials?

Participants allocated to the intervention group will receive the activity monitor Fitbit Flex. For the purpose of the current study, we will blind participants to the feedback lights by covering all wristbands with heat-shrink tubing.

Participants allocated to the control group will receive a Fitbit Flex wristband without the accelerometer containing a material that mimics the weight of the accelerometer and the heat shrink tubing to cover the wristband as in the intervention group

4. What procedures?

The participants from both groups will receive a group-based exercise programme, including a combination of general, stabilisation, aerobic, strengthening and resistance exercises:

Multimodal physical activity intervention group

- Health coaching sessions to identify facilitators and barriers to physical activity participation and to assist participants to achieve their physical activity goals by providing ongoing education and support. An individualised and realistic physical activity plan will be developed for each participant, considering the presence of potential cardiovascular risk factors and participants’ current activity level. In addition, during the health coaching sessions, the physiotherapist will educate patients on the benefits of staying active and will help them to recognise and control, if relevant, pain-related fear, catastrophising and negative thoughts and emotions about pain

- Fitbit Flex to give feedback on the amount of daily physical activity achieved, used by the participants as a motivational tool and to provide feedback during the health coaching sessions

Control group

- Sham coaching giving participants the opportunity to talk about their LBP or other problems, but without providing any therapeutic advice

- Sham Fitbit providing the same information given to the intervention group

5. Who provided?

A physiotherapist who attended a health coaching course, obtained practice experience from experienced health coaches and trained to use active listening techniques

6. How?

Supervised exercises will be delivered in group exercises sessions. The health coaching and sham coaching sessions will be delivered on an individual basis via face-to-face and telephone contact

7. Where?

The trial will be conducted at two outpatient physiotherapy clinics in Presidente Prudente, Sao Paulo, Brazil.

8. When and how much?

The group exercise programme will be led by a physiotherapist with at least 2 years’ clinical experience and will consist of 45-min group sessions with up to 10 people, twice a week for 3 months

For health coaching, a total of 12 health coaching sessions, each session lasting for 30–60 min, will be provided over a 3-month period. The intervention will be delivered during one face-to-face visit each week for the first 6 weeks and then during one telephone contact each week for the last 6 weeks. The participants will be encouraged to wear the Fitbit during all waking hours for the 3-month intervention period

For the control group, the sham health coaching will consist of one weekly session (first 6 weeks being a face-to-face session and the last 6 weeks by telephone contact), each session lasting for 30–60 min, over a 3-month period. In addition, the participants will receive the sham Fitbit and be encouraged to wear it during waking hours for the 3-month study period

9. Tailoring

For the intervention group, the individualised activity plan will be delivered considering the presence of potential cardiovascular risk factors and participants’ current activity level. In addition, the physical activity goals will focus on attempting to meet the physical activity recommendations of at least 150 min of moderate-intensity or 75 min of vigorous-intensity physical activity throughout the week or walking between 7000 to 10,000 steps per day