Parts of this chapter have been reproduced with permission from Keene et al.43 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text.
Developing the GRASP trial exercise interventions
The GRASP trial interventions were developed using Medical Research Council guidance for developing and evaluating complex interventions.63 We took into account clinical guidelines, research evidence, current practice variation, deliverability in the NHS (in terms of staffing, resources and time), expert and patient opinion, acceptability to clinicians and patients, and the need to ensure consistency in delivery and reproducibility. The intervention development and descriptions have been reported previously.43
Intervention development
In Chapter 1, the lack of evidence for particular exercises, treatment intensities or durations were outlined. With no clear evidence or clinical consensus, advice from clinicians, patient and public representatives and other experts was crucial to the development of the GRASP trial interventions. Twenty-six clinicians, researchers, patients and public representatives attended a GRASP intervention development meeting (June 2016). Delegates discussed and evaluated a comprehensive list of 22 exercise types commonly used in clinical practice and/or reported in trials of shoulder pain treatments (see Appendix 3, Table 26). The delegates categorised the exercises into essential exercises, optional exercises or exercises considered not important for managing rotator cuff disorders.
Those selected as essential exercises generally strengthen the posterior rotator cuff muscles (i.e. supraspinatus, infraspinatus and teres minor) and load the shoulder into an elevated position, consistent with current trial evidence.17,64 The GRASP trial, therefore, included these exercise types as an essential component of both the progressive-exercise and best-practice advice exercise interventions. Delegates agreed that both exercise interventions should be as practical and simple as possible. Some exercises were considered important for patients with specific presentations or in particular circumstances. These were included as optional exercises in the progressive-exercise intervention. They were not incorporated into the best-practice advice intervention, which prioritised a simple, progressive set of exercises that were likely to benefit most patients and could be easily understood and performed at home without supervision.
Delegates agreed that stretching was not a priority target in rotator cuff disorders and that range of motion could be incorporated into other active exercises. A posterior capsule/soft tissue stretch for the shoulder was included as an option in the progressive-exercise intervention as we recognised that these stretches feature in many exercise programmes evaluated in other clinical trials.14 Isolated exercises to correct posture towards a theoretical ideal were not included, as there is limited evidence for this approach.65 Experts disagree on whether exercises can or should provoke symptoms or should be symptom-free. There is limited evidence for these alternatives, although evidence is building for the acceptability of mild-to-moderate pain symptoms during exercise.66,67 The participant information booklet, which was included as part of the GRASP trial intervention materials, and treating physiotherapists advised participants that some pain during the exercises is acceptable, provided that they found it manageable and symptoms resolved to an acceptable level within a few hours.
After the meeting, we developed detailed intervention manuals for the treating physiotherapists that described the key components of the progressive-exercise and best-practice advice interventions. We also developed patient-facing materials, which were reviewed by patient representatives.
Internal pilot
As part of the GRASP trial, we ran an internal pilot from February to June 2017 at three sites, recruiting 42 participants. One of the aims of the internal pilot was to test and refine the recruitment process and explore treatment acceptability. The physiotherapists delivering the GRASP exercise interventions were also asked to provide feedback on the delivery of the intervention. The exercise intervention manuals and training materials were subsequently refined to clarify identified misconceptions. The interventions did not require significant modifications.
The GRASP trial interventions
Table 3 summarises the key components of the GRASP exercise interventions. The interventions were delivered face to face and one to one by UK-registered physiotherapists based at physiotherapy and musculoskeletal services across England.
Overview of GRASP trial exercise interventions, as per Template for Intervention Description and Replication criteria
Research physiotherapists from the GRASP trial team provided 1 full day (at least 4–5 hours) of face-to-face training on the progressive-exercise intervention and at least half a day of face-to-face training on the best-practice advice intervention to the relevant delivering physiotherapists. Details on who provided the interventions are provided in Chapter 4. Physiotherapists were trained to deliver either the progressive-exercise intervention or the best-practice advice intervention (not both) to reduce the risk of contamination. Training included the trial background, how to deliver the intervention, the exercises permitted within the trial protocol, behavioural techniques to improve adherence, trial reporting and paperwork, and practical examples using case studies. Physiotherapist manuals were provided, which detailed all aspects of the trial and interventions. GRASP trial team members were available post training to provide support and answer queries.
GRASP trial exercise interventions
Assessment and advice
Appointments were co-ordinated so that participants typically started their first exercise session within 14–28 days of randomisation. The physiotherapist carried out an initial assessment, as per their usual practice, to identify which shoulder movements, in relation to the rotator cuff, were particularly problematic in terms of pain, weakness and restriction, and the associated functional deficits. All GRASP trial participants received a participant information booklet, which contained education and advice relevant to people with a rotator cuff disorder (Table 4). All parts of the booklet contained the same information in the progressive-exercise and best-practice advice intervention groups, with the exception of the specifics of the exercise guidance. Advice included use of over-the-counter analgesia, as per BESS guidance.69 The treating physiotherapist reinforced the education and advice aspects relevant to that participant. All participants were advised to perform the exercises for at least 4 months and to continue to do so for longer if they were still improving or finding them helpful. Physiotherapists delivering the interventions were trained in questioning techniques based on cognitive–behavioural models70 to elicit and address unhelpful beliefs about shoulder pain or exercise that can impede exercise adherence.71
Contents of the GRASP trial participant information booklet
Progressive-exercise intervention
Participants received up to six sessions with a physiotherapist over 16 weeks. The initial session was set to last up to 60 minutes for assessment and treatment initiation, followed by up to five 20- to 30-minute follow-up sessions. The physiotherapist and participant decided how frequently to schedule the review appointments within the 16-week time frame. Six sessions over 16 weeks was set to allow the exercise intensity to be progressed and because it was a volume of physiotherapy within the range of feasible delivery in the NHS. It was also deemed to be a sufficient time for a physiological response in the neuromuscular system.46 The participant information booklet was provided in a file so that instructions on the progressive exercises selected could be inserted, including detailed guidance and photos for each exercise. The physiotherapist and participant jointly chose one to three exercises to address the problems identified during the assessment (). We anticipated participants presenting with different problems and pain irritability and, therefore, the exercises were categorised into three difficulty levels (level 1, 2 and 3 exercises), with progressions within each level and different aims and guidelines to match indications for use.
Process map of the GRASP trial progressive exercise intervention.
Level 1 exercises: simple shoulder movements
Level 1 exercises aimed to reduce fear, encourage normal movement, improve shoulder mobility and build confidence in exercising independently at home (see Appendix 3, ). The exercises were considered appropriate for participants with irritable and/or severe shoulder pain and/or fear avoidance. The frequency and the number of sets and repetitions for each exercise were agreed between the physiotherapist and participant. Depending on symptom severity, it was recommended that some participants could reasonably move straight to level 2 exercises.
Level 2 exercises: progressive structured resistance training
Level 2 exercises included the essential exercises that target strengthening of the posterior rotator cuff muscles and other optional exercises (see Appendix 3, ). The essential exercises focused on movements commonly affected by a rotator cuff disorder (i.e. resisted external rotation, flexion and abduction of the shoulder).64 Resistance exercises for other shoulder movements were optional. If participants were prescribed exercises at level 2, at least one had to be from the essential exercise category.
The American College of Sports Medicine guidance for progressive resistance training recommends two to three sessions of resistance training per week,20 whereas many studies of resistance training in patients with musculoskeletal disorders use daily exercise programmes.21,72 We attempted to strike a balance, ensuring that the resistance training was effective, but also regular enough to address other aims, such as building confidence in moving the arm and re-learning motor skills. We asked GRASP trial participants to do their exercises 5 days per week, with 2 non-consecutive recovery days.
Physiotherapists were taught to regulate the exercise intensity using the modified Borg scale of perceived exertion, an 11-point version of the Rating of Perceived Exertion (RPE) scale,73 validated for quantifying the intensity of resistance exercise.74 Participants started at a moderate load (3 or 4 on the Borg scale) to enhance motivation and adherence and reduce the likelihood of symptom flare-up. contains detailed guidance on the scale and how level 2 exercises were initiated, progressed and regressed. Where appropriate, resistance bands or hand weights were incorporated into the exercise, with the level of resistance recommended being guided by the RPE scale feedback from the participant.
Guidance for setting level 2 resistance exercises in the GRASP trial. (a) Modified Borg scale; (b) setting the initial exercise; and (c) progression and regression decision guidance.
Level 3 exercise: patient-specific functional restoration
It was recommended that participants progress to level 3 when their initial problems (e.g. weakness) began to resolve. The physiotherapist altered the exercise programme to be more task specific (e.g. returning to sport) by devising a new exercise in consultation with the participant. Level 3 exercises aimed to modify the essential resistance-training exercises towards the specific movements required to achieve the participant’s individual functional goals. The exercise could be high or low load, using many or few repetitions, depending on the participant’s needs. It was recognised that not all GRASP trial participants would reach or need this stage of the programme. We anticipated that level 3 exercise instructions would be given face to face and reinforced with written guidance to aid recall.
Optional stretching exercise
Posterior capsule and/or soft tissue stretches of the shoulder (see Appendix 3, ) were included as optional exercises at any stage. We recommend selective use, generally for younger adults engaged in throwing or other overhead athletic or physical activities75 who have posterior capsule tightness. We anticipated these exercises to be suitable for participants with low irritability and if they did not provoke symptoms. Although discomfort and stretching sensations were considered acceptable during stretches, we did not anticipate provocation of anterior shoulder pain or reproduction of the participant’s specific symptoms. We advised holding stretches for 20–30 seconds, but the physiotherapist and participant decided the number of repetitions and frequency.
Exercise progression
During the physiotherapist training, emphasis was placed on the need to progress the exercise interventions as much as possible. To determine that this had in fact occurred, treatment logs completed for each session by the physiotherapists [detailing prescribed exercises, number of sets/repetitions (i.e. volume) and exercise intensity73] were analysed to allow an estimation of treatment progression for the progressive-exercise intervention (see Chapter 4). Exercises were categorised and ranked in order of difficulty level (1 = least difficult, 8 = most difficult) according to the following scale:
passive movements
isometric
active assisted
active (unassisted)
loaded exercises (isotonic) in neutral (0 °)
loaded exercises (isotonic) at 90 °(supported)
as for 6, but unsupported
as for 7, but through range.
Progression of the progressive-exercise intervention was defined as an increase in exercise difficulty, or volume and/or load across attended sessions. Maintained indicates no changes in exercise parameters. Regressed is defined as a decrease in exercise level, or volume and/or load.
Best-practice advice intervention
The best-practice advice intervention was a single face-to-face session with a physiotherapist, lasting up to 60 minutes. With only one session, there was a substantially greater reliance on self-management than in the progressive-exercise intervention. As per the progressive-exercise intervention, participants were given a participant information booklet and the treating physiotherapist reinforced the education and advice aspects that were particularly relevant.
Participants were given a simple set of self-guided exercises, including at least one level of resistance band, to improve shoulder strength and function, which could be progressed and regressed independently at home, depending on their capability. The exercise instructions were given in the participant information booklet and in exercise videos available on the internet and DVDs. We aimed to make the information accessible and appealing to a wide range of individuals by using different media.76
This intervention offered a simpler range of exercise options than the progressive-exercise intervention, although the underlying principles remained the same. The physiotherapist and participant chose one or two exercises from the best-practice advice exercise ladder together (see Appendix 3, ). The exercises on the ladder were arranged with easier exercises on the lower rungs and more difficult exercises on the higher rungs. Participants were recommended to start at the level of exercise that they were capable of undertaking, not necessarily the lowest rung. If two exercises were selected, then these did not need to be from the same rung. The exercises at the lowest level were simple shoulder exercises to reduce fear of movement, encourage normal movement, build shoulder mobility and build confidence in carrying out self-directed exercises. Higher levels introduced a greater extent of resistance exercises for posterior rotator cuff strengthening.
The Borg RPE scale was not used to measure intensity for participants in the best-practice advice group to simplify the programme and maximise independent participant progression. We advised participants that they should find the exercise(s) moderately difficult (i.e. not easy but not extremely hard). They began with one set of eight repetitions at the selected load and aimed to build up to 12 repetitions, exercising once daily for 5 days per week, with 2 non-consecutive rest days. If the exercise(s) became too easy, another set could be added (up to a maximum of three sets). If the expanded set became too easy, the advice was that the exercise(s) should be exchanged for the next level of difficulty. The next exercise, again, started with one set of eight repetitions and built up in the same way. If the participant encountered difficulties, they were advised to reduce the load and/or number of sets/repetitions or regress to an easier exercise.
Strategies to encourage exercise adherence
Estimates suggest that up to 70% of patients do not adhere to prescribed physiotherapy treatments.25 As part of the GRASP trial interventions, we, therefore, incorporated strategies to promote adherence to the exercise interventions. These strategies were less extensive in the best-practice advice intervention than in the progressive-exercise intervention, as they needed to be feasibly delivered within a single session (see Appendix 3, Table 27).
Modifiable behavioural targets were identified from a systematic review of barriers to physiotherapy adherence, including in-treatment exercise adherence, low self-efficacy, depression, anxiety, helplessness, greater perceived barriers to exercise and pain levels during exercise.24 For a summary of the behaviour change techniques used in the GRASP exercise interventions, based on the behaviour change techniques taxonomy,77 see Appendix 3, Table 27. These techniques were selected based on their evidence base,78 successful use in other trials72 and recommendations in the NHS Health Trainer Handbook.79 Participants were asked to complete an exercise action planner and exercise diary, which were tailored to the interventions (see Appendix 3, , and ). Although exercise diaries have questionable reliability for measuring adherence because of issues with real-time compliance and recall bias,80 there is evidence to suggest that they promote adherence.81 We assessed adherence to exercises in the follow-up questionnaires, in which participants reported exercise frequency.
Monitoring, quality assurance and safety
We monitored intervention delivery fidelity using site monitoring visits, quality assurance visits and central monitoring of treatment session logs. Each site was visited annually to ensure that the physiotherapists adhered to the intervention protocol for each exercise arm. A member of the GRASP trial research team attended an appointment session for each trial intervention and completed a standardised checklist covering knowledge of trial procedures, returning trial paperwork, storing trial materials, intervention delivery timing and adherence to intervention protocols. The delivering physiotherapist received feedback at the end of each quality assurance visit. If protocol adherence was below the required standard, further measures (e.g. retraining) were to be instituted after discussion with the trial team and site. Common problems or failings were also shared across sites through regular trial newsletters, e-mails and meetings.
Clinicians delivering the GRASP trial intervention were asked to complete treatment logs at the end of each session. The logs included a checklist that documented the key elements of the session (e.g. exercises prescribed, sets and repetitions, load, injection type and dosage/volume). These were returned to the central GRASP trial team, which reviewed the data for each participant and entered them onto the trial database. For the progressive-exercise intervention, exercise prescription details were checked on arrival. An assessment of progression of exercises over the sessions was not part of the ongoing monitoring. As described above, participants were also allowed to maintain or regress their exercises over the sessions, if clinically appropriate. However, these data were carefully recorded, analysed on completion of the trial and are reported in Chapter 4.
Custom-designed reports of treatment log data were generated and regularly reviewed during the conduct of the trial for central monitoring of the intervention delivery, including the timing, number and duration of sessions, injection details (e.g. volume/dosage), content of treatment sessions, participant attendance and paperwork return. Intervention delivery was, therefore, monitored throughout the trial on a site-by-site and overall basis. Ongoing monitoring during the trial aimed to reveal deviations or discrepancies from the trial protocol so that they could be investigated and, if required, measures taken to address them at an early stage throughout the trial.
Completion of the best-practice advice intervention was defined as attendance at one session. For the progressive-exercise intervention, completion of treatment was defined as attendance at all six treatment sessions, discharged by the treating physiotherapist or referred on for further investigation/treatment (e.g. to orthopaedic consultant). Partial completion was defined as attendance of at least one session but not fulfilling the criteria for full completion described above.
Conclusion
This chapter described the development and details of the GRASP trial interventions for treating rotator cuff disorders tested as part of the trial. The results on how the interventions were implemented and the outcomes from onsite monitoring are detailed in Chapter 4.
