Cardiovascular implications and physical activity in middle-aged and older adults with a history of COVID-19 (CV COVID): a protocol for a randomised controlled trial.

BACKGROUND: The clinical manifestation of COVID-19 is associated with infection and inflammation of the lungs, but there is evidence to suggest that COVID-19 may also affect the structure and function of the cardiovascular system. At present, it is not fully understood to what extent COVID-19 impacts cardiovascular function in the short- and long-term following infection. The aim of the present study is twofold: (i) to define the effect of COVID-19 on cardiovascular function (i.e. arterial stiffness, cardiac systolic and diastolic function) in otherwise healthy individuals and (ii) to evaluate the effect of a home-based physical activity intervention on cardiovascular function in people with a history of COVID-19. METHODS: This prospective, single-centre, observational study will recruit 120 COVID-19-vaccinated adult participants aged between 50 and 85 years, i.e. 80 with a history of COVID-19 and 40 healthy controls without a history of COVID-19. All participants will undergo baseline assessments including 12-lead electrocardiography, heart rate variability, arterial stiffness, rest and stress echocardiography with speckle tracking imaging, spirometry, maximal cardiopulmonary exercise testing, 7-day physical activity and sleep measures and quality of life questionnaires. Blood samples will be collected to assess the microRNA expression profiles, cardiac and inflammatory biomarkers, i.e. cardiac troponin T; N-terminal pro B-type natriuretic peptide; tumour necrosis factor alpha; interleukins 1, 6 and 10; C-reactive protein; D-dimer; and vascular endothelial growth factors. Following baseline assessments, COVID-19 participants will be randomised 1:1 into a 12-week home-based physical activity intervention aiming to increase their daily number of steps by 2000 from baseline. The primary outcome is change in left ventricular global longitudinal strain. Secondary outcomes are arterial stiffness, systolic and diastolic function of the heart, functional capacity, lung function, sleep measures, quality of life and well-being (depression, anxiety, stress and sleep efficiency). DISCUSSION: The study will provide insights into the cardiovascular implications of COVID-19 and their malleability with a home-based physical activity intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05492552. Registered on 7 April 2022.

Capability, Opportunity, and Motivation-Identifying Constructs for Increasing Physical Activity Behaviours in Women with Polycystic Ovary Syndrome (PCOS).

Polycystic ovary syndrome (PCOS) is the commonest endocrinopathy in reproductive-aged women. Because increased adiposity is pivotal in the severity of PCOS-related symptoms, treatment usually incorporates increasing energy expenditure through physical activity (PA). This study aimed to understand the reasons why women with PCOS engage in PA/exercise, which could support the development of targeted behavioural interventions in this at-risk population. Validated questionnaires were administered for self-reported PA levels, quality of life, mental health, illness perception, sleep quality, and capability, opportunity, and motivation (COM) for PA. Using categorical PA data, outcomes were compared between groups; ordinal logistic regression (OLR) was used to identify whether COM could explain PA categorisation. A total of 333 participants were eligible; favourable differences were reported for body mass index, depression, mental wellbeing, self-rated health, illness perception, and insomnia severity for those reporting the highest PA levels. COM scores increased according to PA categorisation, whilst OLR identified conscious and automatic motivation as explaining the largest PA variance. The most active participants reported favourable data for most outcomes. However, determining whether health is protected by higher PA or ill health is a barrier to PA was not possible. These findings suggest that future behavioural interventions should be targeted at increasing patient motivation.

Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study.

BACKGROUND: The PULSE (PostUraL tachycardia Syndrome Exercise) study is a randomised controlled trial assessing the feasibility of conducting a multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with Postural Tachycardia Syndrome (PoTS). The original trial protocol was published in BMC Pilot & Feasibility Studies (accessible at https://doi.org/10.1186/s40814-020-00702-1 ). The PULSE intervention consists of (1) individual assessment; (2) 12-week, twice-weekly, supervised exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention is best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. Sixty-two people (aged 18-60 years) with a confirmed diagnosis of PoTS will be invited to enrol on a feasibility RCT with an embedded qualitative study. The primary outcome will be feasibility; process-related measures will include eligibility, recruitment, randomisation and withdrawal rates, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes will be assessed. In response to the COVID-19 pandemic, here we describe amendments to the trial protocol. METHODS: Restrictions imposed by the COVID-19 pandemic meant it was necessary to change the delivery of the PULSE and control interventions. These changes reflected the need to limit the risk of COVID-19 transmission in a clinical population, some of whom were at increased risk of contracting the virus and suffering serious illness. The major change was that the originally intended centre-based PULSE and control interventions would now be delivered remotely on-line. Subsequently, there were minor changes to the participant eligibility criteria. These decisions followed an on-line co-creation session with people affected by PoTS, and relevant public and professional stakeholders. CONCLUSIONS: We present an update of the original trial protocol in response to the COVID-19 pandemic. No participants were recruited to the original protocol; thus, results will reflect the on-line delivery of the intervention. PULSE will be the first randomised trial to assess the feasibility of conducting a definitive multi-centre RCT testing supervised on-line exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with PoTS. TRIAL REGISTRATION: ISRCTN45323485 registered on 7 April 2020.

Changes in patient activation following cardiac rehabilitation using the Active+me digital healthcare platform during the COVID-19 pandemic: a cohort evaluation.

BACKGROUND: Restrictions on face-to-face contact, due to COVID-19, led to a rapid adoption of technology to remotely deliver cardiac rehabilitation (CR). Some technologies, including Active+me, were used without knowing their benefits. We assessed changes in patient activation measure (PAM) in patients participating in routine CR, using Active+me. We also investigated changes in PAM among low, moderate, and high risk patients, changes in cardiovascular risk factors, and explored patient and healthcare professional experiences of using Active+me. METHODS: Patients received standard CR education and an exercise prescription. Active+me was used to monitor patient health, progress towards goals, and provide additional lifestyle support. Patients accessed Active+me through a smart-device application which synchronised to telemetry enabled scales, blood pressure monitors, pulse oximeter, and activity trackers. Changes in PAM score following CR were calculated. Sub-group analysis was conducted on patients at high, moderate, and low risk of exercise induced cardiovascular events. Qualitative interviews explored the acceptability of Active+me. RESULTS: Forty-six patients were recruited (Age: 60.4 ± 10.9 years; BMI: 27.9 ± 5.0 kg.m2; 78.3% male). PAM scores increased from 65.5 (range: 51.0 to 100.0) to 70.2 (range: 40.7 to 100.0; P = 0.039). PAM scores of high risk patients increased from 61.9 (range: 53.0 to 91.0) to 75.0 (range: 58.1 to 100.0; P = 0.044). The PAM scores of moderate and low risk patients did not change. Resting systolic blood pressure decreased from 125 mmHg (95% CI: 120 to 130 mmHg) to 119 mmHg (95% CI: 115 to 122 mmHg; P = 0.023) and waist circumference measurements decreased from 92.8 cm (95% CI: 82.6 to 102.9 cm) to 85.3 cm (95% CI 79.1 to 96.2 cm; P = 0.026). Self-reported physical activity levels increased from 1557.5 MET-minutes (range: 245.0 to 5355.0 MET-minutes) to 3363.2 MET-minutes (range: 105.0 to 12,360.0 MET-minutes; P < 0.001). Active+me was acceptable to patients and healthcare professionals. CONCLUSION: Participation in standard CR, with Active+me, is associated with increased patient skill, knowledge, and confidence to manage their condition. Active+me may be an appropriate platform to support CR delivery when patients cannot be seen face-to-face. TRIAL REGISTRATION: As this was not a clinical trial, the study was not registered in a trial registry.

Sleep Disruption and Depression, Stress and Anxiety Levels in Women With Polycystic Ovary Syndrome (PCOS) During the Lockdown Measures for COVID-19 in the UK.

Background: Lockdown measures have been enforced globally in response to the COVID-19 pandemic. Given the comorbidity burden in women with polycystic ovary syndrome (PCOS), these lockdown measures may have a particularly negative impact on sleep health, quality of life (QoL), and depression/stress levels in this population. The aim of this study was to explore whether such potential problems were present in women with PCOS during the COVID-19 lockdown in the UK. Methods: UK women with PCOS were recruited through social media into a cross-sectional study during the COVID-19 lockdown. The study survey was delivered online, and included demographic and COVID-19 relevant questions, as well as validated questionnaires/scales, namely the Insomnia Severity Index (ISI), Depression Anxiety and Stress Scale (DASS-21), and PCOSQOL questionnaire. Results: Three hundred and thirty-three women with PCOS [median age: 30.0 (9.0) years] were recruited. Participants were dichotomized based on responses regarding the impact of COVID-19 restrictions on their sleep [negative (N = 242) vs. no/positive (N = 91) impact]. No differences were noted between groups regarding age, time since PCOS diagnosis, body mass index, or number of comorbidities. Based on the ISI, 44.2% of participants reporting a negative impact on sleep exhibited at least moderately severe clinical insomnia. Compared to those who reported no/positive effect on sleep, the participants reporting a negative impact on sleep also reported poorer QoL, based on the total PCOSQOL score, with a greater impact of PCOS and poorer mood in the corresponding PCOSQOL domains. Based on the DASS-21, the latter also had statistically higher depression and stress levels compared to the former. Finally, for this cohort significant inverse correlations were noted between the ISI and PCOSQOL scores (total and domain scores), whilst the DASS-21 and ISI scores were positively correlated (all p-values <0.001). Conclusion: The majority of recruited UK women with PCOS reported that the COVID-19 lockdown had a negative impact on their sleep, which was also associated with impaired QoL and higher depression/stress levels. Whilst further research is required, women with PCOS should be considered a vulnerable population that may experience an adverse impact on sleep, QoL and mental health well-being due to lockdown measures during the COVID-19 pandemic.

Uncertainty, Anxiety and Isolation: Experiencing the COVID-19 Pandemic and Lockdown as a Woman with Polycystic Ovary Syndrome (PCOS).

Background: The COVID-19 pandemic and the related lockdown measures presented a significant risk to physical and mental wellbeing in affected populations. Women with polycystic ovary syndrome (PCOS) are predisposed to several cardio-metabolic risk factors which increase the susceptibility to severe COVID-19 and also exhibit increased likelihood of impaired mental health wellbeing. Therefore, these women who usually receive care from multiple primary and specialist healthcare services may be disproportionately impacted by this pandemic and the related restrictions. This study aimed to explore the lived experience of the first UK national lockdown as a woman with PCOS. Methods: As part of a larger cross-sectional study, 12 women with PCOS living in the UK during the first national COVID-19 lockdown were recruited to a qualitative study. Telephone interviews were conducted in June/July of 2020, and data collected were subjected to thematic analysis. Results: Five themes were identified. "My PCOS Journey" describes participants' experiences of diagnosis, treatment and ongoing management of their PCOS. "Living Through Lockdown" describes the overall experience and impact of the lockdown on all aspects of participants' lives. "Self-care and Managing Symptoms" describe multiple challenges to living well with PCOS during the lockdown, including lack of access to supplies and services, and disruption to weight management. "Healthcare on Hold" describes the uncertainty and anxiety associated with delays in accessing specialised healthcare for a range of PCOS aspects, including fertility treatment. "Exacerbating Existing Issues" captures the worsening of pre-existing mental health issues, and an increase in health anxiety and feelings of isolation. Conclusion: For the women with PCOS in this study, the COVID-19 pandemic and the first national lockdown was mostly experienced as adding to the pre-existing challenges of living with their condition. The mental health impact experienced by the study participants was increased due to lack of access to their normal support strategies, limitations on healthcare services and uncertainty about their risk of COVID-19.

Is It Really Home-Based? A Commentary on the Necessity for Accurate Definitions across Exercise and Physical Activity Programmes.

Background: There is wide discrepancy in how published research defines and reports home-based exercise programmes. Studies consisting of fundamentally different designs have been labelled as home-based, making searching for relevant literature challenging and time consuming. This issue has been further highlighted by an increased demand for these programmes following the COVID-19 pandemic and associated government-imposed lockdowns. Purpose: To examine what specifically constitutes home-based exercise by: (1) developing definitions for a range of terms used when reporting exercise and physical activity programmes and (2) providing examples to contextualise these definitions for use when reporting exercise and physical activity programmes. Methods: A literature search was undertaken to identify previous attempts to define home-based exercise programmes. A working document, including initial definitions and examples were developed, which were then discussed between six experts for further refinement. Results: We generated definitions for universal key terms within three domains (and subdomains) of programme design: location (home-based, community/centre-based, or clinical setting), prescription (structured or unstructured) and delivery (supervised, facilitated, or unsupervised). Examples for possible combinations of design terms were produced. Conclusions: Definitions will provide consistency when using reporting tools and the intention is to discuss the issues presented as part of a Delphi study. This is of paramount importance due to the predicted increase in emerging research regarding home-based exercise.

Changes in Physical Activity and Sedentary Behaviour Due to Enforced COVID-19-Related Lockdown and Movement Restrictions: A Protocol for a Systematic Review and Meta-Analysis.

Prolonged lockdown/restriction measures due to the COVID-19 pandemic have reportedly impacted opportunities to be physically active for a large proportion of the population in affected countries globally. The exact changes to physical activity and sedentary behaviours due to these measures have not been fully studied. Accordingly, the objective of this PROSPERO-registered systematic review is to evaluate the available evidence on physical activity and sedentary behaviours in the general population during COVID-19-related lockdown/restriction measures, compared to prior to restrictions being in place. Defined searches to identify eligible studies published in English, from November 2019 up to the date of submission, will be conducted using the following databases: CENTRAL, MEDLINE, EMBASE, CINAHL, SPORTDiscus, PSYCinfo, Coronavirus Research Database, Public Health Database, Publicly Available Content Database, SCOPUS, and Google Scholar. The applied inclusion criteria were selected to identify observational studies with no restrictions placed on participants, with outcomes regarding physical activity and/or sedentary behaviour during lockdown/restriction measures, and with comparisons for these outcomes to a time when no such measures were in place. Where appropriate, results from included studies will be pooled and effect estimates will be presented in random effects meta-analyses. To the best of our knowledge, this will be the first systematic review to evaluate one complete year of published data on the impact of COVID-19-related lockdown/restriction measures on physical activity and sedentary behaviour. Thus, this systematic review and meta-analysis will constitute the most up-to-date synthesis of published evidence on any such documented changes, and so will comprehensively inform clinical practitioners, public health agencies, researchers, policymakers and the general public regarding the effects of lockdown/restriction measures on both physical activity and sedentary behaviour.

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge. TRIAL DESIGN: Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded process evaluation and health economic evaluation. PARTICIPANTS: Adults with ongoing COVID-19 sequelae more than three months after hospital discharge Inclusion criteria: 1) Adults ≥18 years; 2) ≥ 3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support; 3) substantial (as defined by the participant) COVID-19 related physical and/or mental health problems; 4) access to, and able/supported to use email and internet audio/video; 4) able to provide informed consent; 5) able to understand spoken and written English, Bengali, Gujarati, Urdu, Punjabi or Mandarin, themselves or supported by family/friends. EXCLUSION CRITERIA: 1) exercise contraindicated; 2) severe mental health problems preventing engagement; 3) previous randomisation in the present study; 4) already engaged in, or planning to engage in an alternative NHS rehabilitation programme in the next 12 weeks; 5) a member of the same household previously randomised in the present study. INTERVENTION AND COMPARATOR: Intervention 1: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) programme: an eight week, online, home-based, supervised, group rehabilitation programme. Intervention 2: A thirty-minute, on-line, one-to-one consultation with a REGAIN practitioner (best-practice usual care). MAIN OUTCOMES: The primary outcome is health-related quality of life (HRQoL) - PROMIS® 29+2 Profile v2.1 (PROPr) - measured at three months post-randomisation. Secondary outcomes include dyspnoea, cognitive function, health utility, physical activity participation, post-traumatic stress disorder (PTSD) symptom severity, depressive and anxiety symptoms, work status, health and social care resource use, death - measured at three, six and 12 months post-randomisation. RANDOMISATION: Participants will be randomised to best practice usual care or the REGAIN programme on a 1:1.03 basis using a computer-generated randomisation sequence, performed by minimisation and stratified by age, level of hospital care, and case level mental health symptomatology. Once consent and baseline questionnaires have been completed by the participant online at home, randomisation will be performed automatically by a bespoke web-based system. BLINDING (MASKING): To ensure allocation concealment from both participant and REGAIN practitioner at baseline, randomisation will be performed only after the baseline questionnaires have been completed online at home by the participant. After randomisation has been performed, participants and REGAIN practitioners cannot be blind to group allocation. Follow-up outcome assessments will be completed by participants online at home. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 535 participants will be randomised: 263 to the best-practice usual care arm, and 272 participants to the REGAIN programme arm. TRIAL STATUS: Current protocol: Version 3.0 (27th October 2020) Recruitment will begin in December 2020 and is anticipated to complete by September 2021. TRIAL REGISTRATION: ISRCTN:11466448 , 23rd November 2020 FULL PROTOCOL: The full protocol Version 3.0 (27th October 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

Insights into heart failure hospitalizations, management, and services during and beyond COVID-19.

Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus-2. The clinical presentation of this virus mainly manifests in the respiratory system but may also lead to severe complications in the cardiovascular system. The global burden of COVID-19 has led to an unprecedented need to gain further insight into patient outcomes, management, and clinical practice. This review aims to provide an overview of the current literature on heart failure (HF) hospitalizations, management, and care pathways for supporting patients during and beyond this pandemic. A literature review of five areas of interest was conducted and included: (i) HF hospitalization; (ii) recognizing the needs and supporting HF patients during COVID-19; (iii) supporting rehabilitation services; (iv) transitioning to a telehealth framework; and (v) the need for evidence. Patients with new-onset or existing HF are particularly vulnerable, but a significant reduction in HF hospital admissions has been reported. During these periods of uncertainty, the current care pathways for acute and elective cardiac patients have had to change with the relocation of HF services to protect the vulnerable and reduce transmission of COVID-19. Optimizing community HF services has the potential to reduce the pressures on secondary care during the recovery from this pandemic. Telemedicine and virtual health care are emerging technologies and overcome the risk of in-person exposure. Successful remote delivery of cardiac rehabilitation services has been reported during the pandemic. Delivery of a robust telehealth framework for HF patients will improve communication between clinician and patient. The reduction in HF admissions is a concern for the future and may result in unintended mortality. New-onset and current HF patients must understand their diagnosis and future prognosis and seek help and support using the appropriate platform when needed. Realigning HF services and the use of telemedicine and virtual health care has great potential but needs to be carefully understood to ensure engagement and approval in this population to overcome barriers and challenges.