Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial.

The MAGENTA pragmatic parallel groups randomized controlled trial compared graded exercise therapy (GET) with activity management (AM) in treating paediatric myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). Children aged 8-17 years with mild/moderate ME/CFS and presenting to NHS specialist paediatric services were allocated at random to either individualised flexible treatment focussing on physical activity (GET, 123 participants) or on managing cognitive, school and social activity (AM, 118 participants) delivered by NHS therapists. The primary outcome was the self-reported short-form 36 physical function subscale (SF-36-PFS) after 6 months, with higher scores indicating better functioning. After 6 months, data were available for 201 (83%) participants who received a mean of 3.9 (GET) or 4.6 (AM) treatment sessions. Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM giving an adjusted difference in means of -2.02 (95% confidence interval -7.75, 2.70). One hundred thirty-five participants completed the mean SF-36-PFS at 12 months, and whilst further improvement was observed, the difference between the study groups remained consistent with chance. The two study groups showed similar changes on most of the secondary outcome measures: Chalder Fatigue, Hospital Anxiety and Depression Scale: Depression, proportion of full-time school attended, a visual analogue pain scale, participant-rated change and accelerometer measured physical activity, whether at the 6-month or 12-month assessment. There was an isolated finding of some evidence of an improvement in anxiety in those allocated to GET, as measured by the Hospital Anxiety and Depression Scale at 6 months, with the 12-month assessment, and the Spence Children's Anxiety scale being aligned with that finding. There was weak evidence of a greater risk of deterioration with GET (27%) than with AM (17%; p = 0.069). At conventional UK cost per QALY thresholds, the probability that GET is more cost-effective than AM ranged from 18 to 21%. Whilst completion of the SF-36-PFS, Chalder Fatigue Scale and EQ-5D-Y was good at the 6-month assessment point, it was less satisfactory for other measures, and for all measures at the 12-month assessment.  Conclusion: There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points.  Trial registration: The study protocol was registered at www.isrctn.com (3rd September 2015; ISRCTN 23962803) before the start of enrolment to the initial feasibility phase.

Life in lockdown: a qualitative study exploring the experience of living through the initial COVID-19 lockdown in the UK and its impact on diet, physical activity and mental health.

BACKGROUND: In response to the COVID-19 pandemic, the UK imposed a national lockdown prompting change to daily routines. Among behaviours impacted by the lockdown, diet and physical activity may be particularly important due to their association with mental health and physical health. The aim of this study was to explore people's experiences of how lockdown impacted their physical activity, dietary behaviours and mental health, with a view to informing public health promotion. METHODS: This phenomenological qualitative study used semi-structured telephone interviews. Interviews were audio-recorded and transcribed verbatim. Thematic analysis was conducted, guided by the Framework Approach. RESULTS: Forty participants (28 female) completed an interview (mean duration: 36 min) between May and July 2020. The overarching themes identified were (i) Disruption (loss of routines, social interaction and cues to physical activity) and (ii) Adaptation (structuring the day, accessing the outdoor environment, finding new ways for social support). The disruption to daily routines altered people's cues for physical activity and eating; some participants spoke of comfort eating and increased alcohol intake in the early days of lockdown, and how they consciously tried to change these when restrictions lasted longer than first anticipated. Others spoke of adapting to the restrictions using food preparation and meals to provide both routine and social time for families. Disruptions from the closure of workplaces resulted in flexible working times for some, allowing for physical activity to be built into the day. In later stages of restrictions, physical activity became an opportunity for social interaction and several participants reported intending to continue to replace sedentary means of socialising (e.g., meeting in cafes) with more active, outdoor activities (e.g., walking) once restrictions were lifted. Staying active and building activity into the day was seen as important to support physical and mental health during the challenging times of the pandemic. CONCLUSIONS: Whilst many participants found the UK lockdown challenging, adaptations to cope with the restrictions presented some positive changes related to physical activity and diet behaviours. Helping people sustain their new healthier activities since restrictions have lifted is a challenge but presents an opportunity for public health promotion.

Results of the feasibility phase of the managed activity graded exercise in teenagers and pre-adolescents (MAGENTA) randomised controlled trial of treatments for chronic fatigue syndrome/myalgic encephalomyelitis.

BACKGROUND: Chronic fatigue syndrome (CFS) also known as myalgic encephalomyelitis (ME) is relatively common in young people and causes significant disability. Graded exercise therapy (GET) and activity management are recommended by the National Institute for Health and Care Excellence (NICE) despite a limited evidence-base for either treatment in paediatric CFS/ME. This paper reports on feasibility and acceptability measures from the feasibility phase of the ongoing MAGENTA randomised controlled trial (RCT) investigating GET versus activity management for young people with CFS/ME. METHODS: Setting: Three specialist secondary care National Health Service (NHS) Paediatric CFS/ME services (Bath, Cambridge and Newcastle).Participants: Young people aged 8-17 years with a diagnosis of mild to moderate CFS/ME. Young people were excluded if they were severely affected, referred to cognitive behavioural therapy (CBT) at initial assessment or unable to attend clinical sessions.Interventions: GET and activity management delivered by physiotherapists, occupational therapists, nurses and psychologists. Families and clinicians decided the number (typically 8-12) and frequency of appointments (typically every 2-6 weeks).Outcome Measures: Recruitment and follow-up statistics. We used integrated qualitative methodology to explore the feasibility and acceptability of the trial processes and the interventions. RESULTS: 80/161 (49.7%) of eligible young people were recruited at two sites between September 2015 and August 2016, indicating recruitment to the trial was feasible. Most recruitment (78/80; 97.5%) took place at one centre. Recruitment consultations, online consent and interventions were acceptable, with less than 10% in each arm discontinuing trial treatment. Response rate to the primary outcome (the SF36-PFS at 6 months) was 91.4%. Recruitment, treatment and data collection were not feasible at one centre. The site was withdrawn from the study.In response to data collected, we optimised trial processes including using Skype for recruitment discussions; adapting recruiter training to improve recruitment discussions; amending the accelerometer information leaflets; shortening the resource use questionnaires; and offering interventions via Skype. These amendments have been incorporated into the full trial protocol. CONCLUSIONS: Conducting an RCT investigating GET versus activity management is feasible and acceptable for young people with CFS/ME. TRIAL REGISTRATION: ISRCTN23962803 10.1186/ISRCTN23962803, date of registration: 03 September 2015.

Associations within school-based same-sex friendship networks of children's physical activity and sedentary behaviours: a cross-sectional social network analysis.

BACKGROUND: Physical activity in children is associated with better physical and mental health but many children do not meet physical activity guidelines. Friendship groups are potentially an important influence on children's physical activity and sedentary time. This paper examines the association between children of physical activity and sedentary time in school-based same-sex friendship networks, for both moderate-to-vigorous intensity physical activity (MVPA) and sedentary time. Moreover, considering the methodological challenges of conducting and interpreting these analyses, we provide examples of how to analyse these data and interpret results to encourage further work in the area. METHODS: Accelerometer data for 1223 children, aged 8-9 years, were collected in 2015-2016 and analysed in 2017. Mean accelerometer minutes of MVPA and sedentary time were calculated. Children named up to four school friends and same-sex school-based friendship networks were constructed. Network models, which include correlation between friends, were fitted by sex. RESULTS: Both MVPA and sedentary time were found to be associated via the friendship networks, for both boys and girls. The network autocorrelation was 0.21 (95% CI: 0.15 to 0.26) for boys' MVPA, and 0.14 (95% CI: 0.07 to 0.21) for sedentary time. Network autocorrelation between girls was weaker, with 0.13 (95% CI: 0.06 to 0.19) for MVPA and 0.11 (95% CI: 0.05 to 0.17) for sedentary time. CONCLUSIONS: Physical activity and sedentary time of boys and girls are associated with the physical activity and sedentary time respectively of others within same-sex friendship networks, and these associations are comparable to other known factors. In this study, the correlation between friends was stronger for boys than girls, and stronger for MVPA than for sedentary time. These findings suggest that friendship networks play a part in understanding children's physical activity and sedentary time and could play a valuable role in developing effective interventions.

Association of parents' and children's physical activity and sedentary time in Year 4 (8-9) and change between Year 1 (5-6) and Year 4: a longitudinal study.

BACKGROUND: Parents could be important influences on child physical activity and parents are often encouraged to be more active with their child. This paper examined the association between parent and child physical activity and sedentary time in a UK cohort of children assessed when the children were in Year 1 (5-6 years old) and in Year 4 (8-9 years old). METHODS: One thousand two hundred twenty three children and parents provided data in Year 4 and of these 685 participated in Year 1. Children and parents wore an accelerometer for five days including a weekend. Mean minutes of sedentary time and moderate-to-vigorous intensity physical activity (MVPA) were derived. Multiple imputation was used to impute all missing data and create complete datasets. Linear regression models examined whether parent MVPA and sedentary time at Year 4 and at Year 1 predicted child MVPA and sedentary time at Year 4. Change in parent MVPA and sedentary time was used to predict change in child MVPA and sedentary time between Year 1 and Year 4. RESULTS: Imputed data showed that at Year 4, female parent sedentary time was associated with child sedentary time (0.13, 95% CI = 0.00 to 0.27 mins/day), with a similar association for male parents (0.15, 95% CI = -0.02 to 0.32 mins/day). Female parent and child MVPA at Year 4 were associated (0.16, 95% CI = 0.08 to 0.23 mins/day) with a smaller association for male parents (0.08, 95% CI = -0.01 to 0.17 mins/day). There was little evidence that either male or female parent MVPA at Year 1 predicted child MVPA at Year 4 with similar associations for sedentary time. There was little evidence that change in parent MVPA or sedentary time predicted change in child MVPA or sedentary time respectively. CONCLUSIONS: Parents who were more physically active when their child was 8-9 years old had a child who was more active, but the magnitude of association was generally small. There was little evidence that parental activity from three years earlier predicted child activity at age 8-9, or that change in parent activity predicted change in child activity.

Change in children's physical activity and sedentary time between Year 1 and Year 4 of primary school in the B-PROACT1V cohort.

BACKGROUND: The aim of this study was to examine how children's and parents' physical activity changes from Year 1 (5-6) to Year 4 (8-9 years of age). METHODS: Data are from the Bristol (UK) B-PROACT1V cohort. Fifty-seven primary schools were recruited when the children were in Year 1, with 1299 children and their parents providing data. Forty-seven schools were re-recruited in Year 4, with 1223 children and parents providing data (685 of whom participated in Year 1). Children and at least one parent wore an accelerometer for 5 days including a weekend and mean minutes of sedentary time, moderate-to-vigorous intensity physical activity (MVPA) and accelerometer counts per minute (CPM) were derived. Multiple imputation was used to impute missing data for all 1837 families who took part, including those who participated at just one time. Paired t-tests examined if there was statistical evidence of change in accelerometer measures. RESULTS: Multiple imputation and observed data were comparable and results using complete observed data were mostly the same as those using imputed data. Imputed data showed that mean boys' CPM decreased from 747 to 673 (difference in mean 74 [95% CI 45 to 103]) and girls' from 686 to 587 (99 [79 to 119]). Boys' time spent in MVPA reduced from 72 to 69 (3 [0 to 6]) and girls' from 62 to 56 (7 [4 to 9]) minutes per day. There were increases in sedentary time for both boys (354 to 428 min, 74 [61 to 88]) and girls (365 to 448, 83 [71 to 96]). There was no evidence of change in parent CPM or MVPA. Mothers' sedentary time increased by 26 min per day [16 to 35]. CONCLUSIONS: There were similar increases in sedentary time in girls and boys between age 5-6 and 8-9, and decreases in MVPA that were more marked in girls. The similarity of multiple-imputed and complete observed data suggest that these findings may not be markedly affected by selection bias. Result support early interventions to prevent the age-related decline in children's physical activity.