Is an online exercise platform, such as Pactster/Beam an acceptable tool to promote exercise participation in adults with cystic fibrosis, with or without online physiotherapy support?

Background

Exercise is strongly promoted as part of a comprehensive treatment plan for people with cystic fibrosis (CF). As well as pharmacological treatments, CF management requires intensive physiotherapy input in terms of chest clearance and the promotion of activity. Regular exercise is positively associated with measures of fitness and lung function in those with CF (1, 2) and is strongly promoted by the U.K. Cystic Fibrosis Trust (3). Furthermore, peak aerobic capacity has been shown to be associated with better lung function and lower mortality rates (4). Adults should perform 150 minutes or more of moderate aerobic activity per week (5, 6). Disease severity may require the amount of exercise to be adjusted, although patients who are more physically restricted are still encouraged to engage in activity.

Evidence for the apparent benefit of exercise mostly comes from observational studies or before-and-after intervention studies, with few randomised controlled trials (RCT) to prove causality (7). One year-long RCT showed that an unsupervised exercise training programme improved fitness assessed by changes in blood lactate levels (8), whilst a three year-long program for CF patients aged 7–19 failed to show an improvement in exercise tolerance; this latter trial did not meet its primary endpoint which was decline in forced expiratory volume in one second (FEV1) (-3.47 versus -1.46, p = 0.07), but did show a difference in decline in forced vital capacity (FVC) (-2.42 versus -0.25, p = 0.02) favouring the exercise programme (9). A six-month partially-supervised training programme included three groups: strength training, endurance training and controls (10). Both interventions showed a clinical and statistical improvement in FEV1, with an improvement in aerobic performance, though benefits were not sustained. The authors attribute this in part to the lack of ongoing supervision. Adherence with exercise is poor (11) with low self-reported adherence rates (24%) despite patients’ recognition of the benefits of exercise (12).

Patients with chronic obstructive pulmonary disease (COPD) report that group pulmonary rehabilitation helps individuals come to terms with their chronic illness and overcome the initial barriers to physical activity; furthermore they value support from a supervising healthcare professional (13). Group based exercise programmes are restricted in CF due to the risk of cross-infection. Online exercise classes can potentially overcome this barrier, whilst providing the community support seen in traditional pulmonary rehabilitation. Furthermore, they permit virtual support from a trained CF physiotherapist to tailor exercise programmes and provide encouragement.

Pactster (now rebranded as BEAM Cystic Fibrosis, www.beamfeelgood.com) is a health specific online exercise video resource which was initially launched in May 2016 and was free for people with CF, with funding provided by the U.K. Cystic Fibrosis Trust. This permitted patients with CF to exercise virtually as a group, with physiotherapy support via an online interactive forum. In this study, we assess the feasibility of Pactster as a tool to promote exercise participation, and in a randomised controlled trial (RCT) we compared access to Pactster alone to Pactster plus online physiotherapy support. This research was conducted prior to the COVID-19 pandemic. The concept of online exercise has now got a much larger reach out of global health necessity, and therefore it remains important to understand its place in healthcare moving forward. Since conducting this research Pactster has since rebranded as BEAM Cystic Fibrosis but uses the same concept and support network. For the purposes of this research, it will be continued to be referred to as Pactster.

It is important to recognise the recent role cystic fibrosis transmembrane conductance regulator (CFTR) modulator treatments have had in CF care. The face of CF is evolving and there is an increasing focus on exercise as modulators have the potential to improve exercise capacity. It is important that clinicians can meet this changing need and provide suitable options to allow structured exercise support away from the CF centre for sustainable care. Although this study commenced prior to the licensing of what are now common treatments (Kaftrio), their role in the future of CF care needs to be considered.

Method

Thirty patients were randomised to receive:

a Pactster plus online physiotherapy support.

b Pactster alone.

We used a physical activity questionnaire to measure patient reported exercise and barriers to exercise participation in all adult CF patients attending clinic between April–July 2018.

Eligibility criteria was: a percent predicted FEV1 (ppFEV1) of 30% or more, internet access, and patient reported exercise totalling less than 150 minutes a week. Exclusion criteria included lung transplantation, significant arthropathy or osteoporosis, neurological disease, supplementary oxygen, and immobility.

The intervention was online physiotherapy support via the Pactster website. The physiotherapists posted daily encouraging messages within the private community and provided the opportunity for users to engage in discussion and plan supervised workouts. The physiotherapist scheduled two exercise sessions per day (10am and 3pm) of varying content, which were later increased to include one evening session (6.30pm) and a Saturday morning session (9am) at the users request.

In the control group, (Pactster Alone) users were aware they were to be self motivated and utilise the available resources. Patients in both arms of the study had access to the same Pactster exercise video library content, they could communicate with each other via their retrospective closed community to provide peer encouragement, and received face-to-face physiotherapy input as per usual CF care, for example routine clinic visits. The control group received no scheduled sessions or additional online physiotherapist support.

The primary outcome was the acceptability of Pactster to all patients included in the RCT at six weeks. We compared changes from baseline and six weeks’ follow up with regards to exercise capacity (measured by the Chester Step Test), ppFEV1 and EQ-5D-5L between groups. By meeting the inclusion criteria, all participants were deemed to be clinical stable at the start of the trial. The Chester Step Test is a multi-staged exercise test, in which patients repeatedly step up and down onto a 20cm high box at a progressively increasing pace. The aerobic capacity is predicted by plotting repeated measures of heart rate through which a line of best fit is plotted, projecting up to the maximum heart rate and an estimate of corresponding oxygen uptake (14). As per the Chester Step Test Protocol 8″ (20cm) Step is generally suitable for those under 40 years of age who take little or no regular physical exercise.

Physiotherapy time was recorded to calculate the additional costs incurred by online physiotherapy support.

Ethics approval was provided by the North West Greater Manchester East Research Ethics Committee (18/NW/0247).

Statistical methods

The primary outcome was the acceptability of Pactster to all patients involved in the study, in a binary ‘yes/no’ question. A sample size of 22 was required in a single-sample binomial analysis to have 80% power to the 0.05 significance level, assuming an 80% acceptability rate. The null hypothesis was that half of patients would report that Pactster was acceptable. We assumed Pactster was unacceptable in non-responders. Patients were randomised using www.sealedenvelopes.com.

Means and 95% confidence intervals (95% CI) were provided for data that is normally distributed, otherwise medians and interquartile ranges (IQR) were used. The total hours of support provided by the physiotherapist was calculated. Data used to estimate quality adjusted life-years (QALY) was collected using the EQ-5D-5L. This collects information regarding patient’s health-related quality of life, which was transformed using a standard algorithm to produce a health status utility score. Mean QALY differences between the groups was generated from patient’s utility values using a regression approach, controlling for baseline utility, intervention group, ppFEV1, sex and age.

Results

A total of 230 (78%) patients were screened out of the 296 patients under the care of the Adult Newcastle upon Tyne Service (Figure 1) between April 2018–July 2018. The remaining 66 patients who did not attend clinic in this time were mostly those with minimal lung disease. Of the 230 patients, only 75 (33%) reported doing more than 150 minutes of exercise a week, with two-thirds performing insufficient or no exercise.

Figure 1 shows information from the physical activity questionnaire and screening, with barriers to exercise in those that did not want to participate in the RCT and declined to do more exercise. The reasons for declining to do more exercise included: time pressures and restrictions, an active dislike of exercise despite encouragement, or the perception that online exercise was ‘not their thing’.

DNA = did not attend, LTOT = long term oxygen therapy.

Figure 1: Overview of CF patients and exercise participation, and eligibility for the randomised controlled trial.

Thirty of 95 eligible patients consented to take part in the study, of whom half were female. The mean age (standard deviation, SD) was 27.2 (SD 8.1) and the ppFEV1 was 62% (SD 22%), with a range of 31% to 101%. The mean (SD) body mass index (BMI) was 22.5 (4.3), and 16 (53%) were homozygous for Phe508del CFTR mutations. The median (IQR) of reported exercise was 0 (0–70), with 16 (53%) patients completing no exercise. Of the remaining 14 (47%), exercise ranged from 20–150 minutes. Further information is shown in Table 1.

Table 1: Baseline characteristics of RCT patients in groups A) Pactster and online physiotherapy support (OPS) and B) Pactster without online physiotherapy support.

Of the 30 patients recruited, five did not provide any outcome data at the six weeks’ assessment (see Figure 2). Nineteen reported engaging with the Pactster website and participated in the online videos over the six weeks.

In the group that received Pactster and online physiotherapy, 11 of 15 used Pactster. In the Pactster without online physiotherapy group, 10 of 15 used Pactster. The reasons given by trial participants for not engaging with Pactster included a preference for the gym, a desire not to interact with other CF patients, feeling too unwell, and a perception that the exercise types were unsuitable.

Figure 2: Consort diagram for eligible patients, with groups A) Pactster and online physiotherapy support (OPS) and B) Pactster without online physiotherapy support.

Primary outcome

25 patients reported that Pactster was acceptable (p <0.001), and five did not engage with follow up for whom we assumed it was unacceptable. Nineteen (63%) patients stated that they would like physiotherapy support, six (20%) stated they did not want physiotherapy support, and five (17%) did not answer.

For questions relating to the acceptability of Pactster, the median values were similar between groups though the median was numerically higher with physiotherapy input in terms of patients reporting how hard they worked (see Table 2).

Table 2: Acceptability of Pactster in groups A Pactster and online physiotherapy support (OPS) and B Pactster without online physiotherapy support.

Secondary outcome

The change in ppFEV1 was greater in the physiotherapy support group, with a between group difference of 6% (see Table 3). For the Chester step test, the change in average aerobic capacity and exercise time was greater with the physiotherapy group, though the between group differences were small. There were no between group differences with respect to the utility score, or the unadjusted or adjusted QALY scores.

Table 3: Difference between six week and baseline measures, groups A Pactster and online physiotherapy support (OPS) and B Pactster without online physiotherapy support.

*Surrogate measure of aerobic capacity, mls O2/kg/min.

Physiotherapy time

A total of 939 scheduled minutes of exercise were available to the participants in the physiotherapy group over the six weeks. There were 68 scheduled sessions in total, which ranged from 6–60 minutes in duration. 60 of the sessions were scheduled routinely with a morning and afternoon option every weekday. Eight additional sessions were offered on Saturdays/evenings. Of all sessions offered, 591 minutes of exercise were completed by seven different participants. This underestimates engagement, as many performed their exercise independently. A total of nine participants reported completing the recommended sessions outside of the scheduled time slots at a time that was convenient to them.

Within the physiotherapy support group, a total of 32 posts were made in the Pactster Community by the physiotherapist over the course of the six weeks. Participants had phone support (45 minutes), email support (32 minutes) and 207 minutes of physiotherapy time utilised for online posting (messages of support) and scheduling of daily sessions. In total, 284 minutes (4 hours 44 minutes) of band six physiotherapy time was provided. Based on a cost per unit hour of £44 (€53) for a band six physiotherapist (which includes all add on costs such as management, estates, overheads for example)(15) the total cost was £208 (€250) over the six week period. Although it was observed that many of these duties did not require a band six physiotherapist, and that a band four physiotherapy associate practitioner would have sufficed (£137/€164).

Within the Pactster without online physiotherapy group, a total of 97 minutes of physiotherapy time was required to assist with sign up and to arrange follow up. This comprised of 25 minutes on the phone and 72 minutes in total emailing individuals with regards to confirming set up and a reminder about completing their exercise diaries. We included the latter in the physiotherapy time, as this prompt to remind patients to complete their exercise diaries may have inadvertently prompted exercise.

Quotations from questionnaires

Within the physiotherapy support group, the main feedback was that participants ‘couldn’t always engage with the sessions at the scheduled times’, but despite this, ‘appreciated the physiotherapy input and motivation’ which encouraged them to complete the same sessions in their own time. It was felt the physiotherapy input was ‘helpful to moderate and guide the use of the forum’, but many did not feel it was necessary for them to interact with other users. It was suggested that ‘once a week physiotherapy input would be a good incentive to encourage ongoing participation’ as ‘it is easier when someone tells you what to do’.

Although the Pactster alone group did not have access to online physiotherapy support, many felt it would be ‘motivating to have the professional input’, which could provide ‘structure on what to do’. There was some hesitation in engagement in conversations with other members as the individuals ‘did not know the other user’s personal circumstances or backgrounds’. It was suggested that the ‘Physiotherapist could help direct conversations’. One individual did comment however that they ‘see enough physios and would prefer to do it themselves’.

Discussion

In adults with CF and low exercise participation, we have shown that an online, exercise platform is acceptable and is associated with an increase in weekly reported exercise, in those motivated to access exercise support. Online exercise supervision by physiotherapists may lead to improvements in lung function, and physical fitness; this may be as a result of increased effort given the higher levels of perceived exertion in the physiotherapy support group, however these results require replication in a larger, multicentre study, and should include a more objective measure of patient effort. The costs associated with providing online physiotherapy support appear to be acceptable, but require further examination in a health economic evaluation. In common with previous studies, exercise in this patient group appears to be safe, and there were no adverse events during the study period.

The study has several strengths. We have described the exercise practices of a large cohort of CF patients. Randomisation was performed by an external agency with allocation concealment to patients and researchers. Prior to the COVID-19 pandemic, there had been a lack of studies looking at the impact of physiotherapy input within online exercise programmes. It is now even more important to explore methods to reach our patient group remotely. Maintaining exercise adherence is challenging, and previous research suggests that supervision is associated with better outcome (9). Our exercise programmes were tailored towards the patient’s needs and preferences, with classes for beginners, intermediate and advanced users across a range of activities for strength training, aerobic training, and mobility practices. This is important as a ‘one size fits all’ approach does not appear to be successful. We used multiple approaches to measure exercise participation, which included patient diaries, monitoring via the website and face-to-face and telephone interactions.

Key limitations were the short study duration and small sample size. This prohibits long-term habitual life-style changes and means that secondary outcome should be interpreted with caution. A larger, longer study should include measure of lung disease such as exacerbation frequency and consider full cardiopulmonary exercise testing. We measured aerobic capacity based on the patient’s heart rate whilst performing the Chester Step Test. Whilst this cannot be taken as an accurate measure of the maximal oxygen uptake (VO2 max), it correlates well with VO2 max and is appropriate for tracking aerobic fitness due to its high test-retest reliability (14, 16, 17). The step test can be assessed in clinic, and the patient could undertake assessment at home at minimal cost and effort to monitor their own fitness. The Chester Step Test has been used via videoconferencing to remotely assess exercise capacity in CF (18) however further validation work is required in the CF population. Lastly, including the use of activity monitors would have added precision to measures of activity levels.

Use of online resources has been explored as a tool to increase exercise engagement (18, 19) but FEV1 outcome has not been examined. Previous RCTs of traditional exercise programmes (not online) showed a trend towards (8, 9) or a convincing improvement (10) in FEV1 with exercise. These improvements do not appear to be sustained over time without supervision. This issue may be addressed with longer term online physiotherapy support, which our study suggests can be delivered at a reasonable cost, but require further study as the passage of time could primarily account for the drop-off in adherence, irrespective of support.

We measured the EQ-5D-5L to perform a health-economic evaluation to guide a future larger study. Despite potentially clinically relevant differences in lung function and exercise capacity, there was no between group difference in the utility scores. This may be due to a lack of efficacy of the intervention, or the EQ-5D-5L may lack sensitivity in this patient group.

Following completion of this study we have continued to value the use of online exercise platforms with virtual physiotherapy support, and this has been of particular benefit during the COVID-19 pandemic where face-to-face sessions were limited. Virtual exercise sessions and step testing are now part of usual care within the Newcastle Upon Tyne Adult CF Service, which has been well-received. A single Pactster community was created, and the ongoing intervention was successfully provided by a band four physiotherapy associate practitioner, which reduces cost. Our study was perhaps too short for patients to foster supportive online relationships with fellow patients that could help with adherence.

In the post COVID-19 and CFTR modulator era and the evolving face of CF care, the findings of this research are pertinent to the James Lind Alliance CF Research Priorities. In particular point six, ‘what effective ways of motivation, support and technologies help people with Cystic Fibrosis improve and sustain adherence to treatment?’ and point seven ‘can exercise replace chest physiotherapy for people with Cystic Fibrosis?’ (20). The information obtained could feed into larger studies to provide valuable information to the CF population.

This study has demonstrated the acceptability of online community exercise platforms such as Pactster (now operating under the branding BEAM for Cystic Fibrosis) as a method to encourage exercise participation in those with low levels of baseline exercise performance who are seeking to increase their exercise levels. Provision of physiotherapy support on the platform was well received by users, helps provide an appropriately tailored programme, and provides promising clinical results. This approach can be readily replicated by physiotherapy teams. This meets the CF patient requirement for segregation, and overcomes the geographical challenges faced by CF centres in providing ongoing, regular support exercise programmes at a reasonable cost.

Key points

• Patients with CF cannot exercise together due to the risk of cross infection.

• Online exercise platforms allow group exercise and virtual interaction.

• In this study, an online exercise platform is acceptable to 83% of patients.

• Additional online physiotherapy support may improve FEV1.

Declarations of interest

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: C Echevarria reports grants from National Institute of Health Research, outside of the submitted work, and no competing interests in relation to this work. Rachael Bass, Stephen Bourke, Lisa Morrison, Lucia Diego-Vicente, Emma Hope, Laura Blanch, Sarah Lenaghan and Carlos Echevarria.

Funding sources

The lead authors’ salary was paid for by the U.K. Cystic Fibrosis Trust as part of a fellowship (CFT project No: PF-001).

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