Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial.

INTRODUCTION: Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes. METHODS AND ANALYSIS: A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention. ETHICS AND DISSEMINATION: The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN68786622. PROTOCOL VERSION: 2.0 (16 May 2023).

Perspectives of Patients With Chronic Respiratory Diseases and Medical Professionals on Pulmonary Rehabilitation in Pune, India: Qualitative Analysis.

BACKGROUND: Chronic respiratory diseases (CRDs) contribute significantly to morbidity and mortality worldwide and in India. Access to nonpharmacological options, such as pulmonary rehabilitation (PR), are, however, limited. Given the difference between need and availability, exploring PR, specifically remotely delivered PR, in a resource-poor setting, will help inform future work. OBJECTIVE: This study explored the perceptions, experiences, needs, and challenges of patients with CRDs and the potential of and the need for PR from the perspective of patients as well as medical professionals involved in the referral (doctors) and delivery (physiotherapists) of PR. METHODS: In-depth qualitative semistructured interviews were conducted among 20 individuals diagnosed with CRDs and 9 medical professionals. An inductive thematic analysis approach was used as we sought to identify the meanings shared both within and across the 2 participant groups. RESULTS: The 20 patients considered lifestyle choices (smoking and drinking), a lack of physical activity, mental stress, and heredity as the triggering factors for their CRDs. All of them equated the disease with breathlessness and a lack of physical strength, consulting multiple doctors about their physical symptoms. The most commonly cited treatment choice was an inhaler. Most of them believed that yoga and exercise are good self-management strategies, and some were performing yoga postures and breathing exercises, as advised by friends or family members or learned from a televised program or YouTube videos. None of them identified with the term "pulmonary rehabilitation," but many were aware of the exercise component and its benefits. Despite being naive to smartphone technology or having difficulty in reading, most of them were enthusiastic about enrolling in an application-based remotely delivered digital PR program. The 9 medical professionals were, however, reluctant to depend on a PR program delivered entirely online. They recommended that patients with CRDs be supported by their family to use technology, with some time spent with a medical professional during the program. CONCLUSIONS: Patients with CRDs in India currently manage their disease with nonguided strategies but are eager to improve and would benefit from a guided PR program to feel better. A home-based PR program, with delivery facilitated by digital solutions, would be welcomed by patients and health care professionals involved in their care, as it would reduce the need for travel, specialist equipment, and setup. However, low digital literacy, low resource availability, and a lack of expertise are of concern to health care professionals. For India, including yoga could be a way of making PR "culturally congruent" and more successful. The digital PR intervention should be flexible to individual patient needs and should be complemented with physical sessions and a feedback mechanism for both practitioners as well as patients for better uptake and adherence.

Protocol for a single-centre mixed-method pre-post single-arm feasibility trial of a culturally appropriate 6-week pulmonary rehabilitation programme among adults with functionally limiting chronic respiratory diseases in Malawi.

INTRODUCTION: Malawi has a substantial burden of chronic respiratory diseases (CRDs) which cause significant morbidity and loss of economic productivity, affecting patients, families and health systems. Pulmonary rehabilitation (PR) is a highly recommended non-pharmacological intervention in the clinical management of people with CRDs. However, Malawi lacks published evidence on the implementation of PR for people with CRDs. This trial will test the feasibility and acceptability of implementing a culturally appropriate hospital-based PR programme among adults with functionally limiting CRDs at Queen Elizabeth Central Hospital in Blantyre, Malawi. METHODS AND ANALYSIS: This is a single-centre mixed-methods pre-post single-arm feasibility trial. Ten patients aged ≥18 years, with a spirometry confirmed diagnosis of a CRD and breathlessness of ≥2 on the modified Medical Research Council dyspnoea scale, will be consecutively recruited. Their baseline lung function, exercise tolerance and health status will be assessed; including spirometry, Incremental Shuttle Walk Test and Chronic Obstructive Pulmonary Disease Assessment Test, respectively. Pretrial semistructured in-depth interviews will explore their experiences of living with CRD and potential enablers and barriers to their PR uptake. Along with international PR guidelines, these data will inform culturally appropriate delivery of PR. We initially propose a 6-week, twice-weekly, supervised centre-based PR programme, with an additional weekly home-based non-supervised session. Using combination of researcher observation, interaction with the participants, field notes and informal interviews with the participants, we will assess the feasibility of running the programme in the following areas: participants' recruitment, retention, engagement and protocol adherence. Following programme completion (after 6 weeks), repeat assessments of lung function, exercise tolerance and health status will be conducted. Quantitative changes in clinical outcomes will be described in relation to published minimal clinically important differences. Post-trial semistructured interviews will capture participants' perceived impact of the PR programme on their quality of life, enablers, and barriers to fully engaging with the programme, and allow iteration of its design. ETHICS AND DISSEMINATION: Ethical approval for this trial was obtained from University of Malawi College of Medicine Research and Ethics Committee (COMREC), Blantyre, Malawi (protocol number: P.07/19/2752) and University of Leicester Research Ethics Committee, Leicester, UK (ethics reference: 31574). The results of the trial will be disseminated through oral presentations at local and international scientific conferences or seminars and publication in a peer-reviewed journal. We will also engage the participants who complete the PR trial and the Science Communication Department at Malawi-Liverpool-Wellcome Trust Clinical Research Programme to organise community outreach activities within Blantyre to educate communities about CRDs and PR. We will also broadcast our trial results through national radio station programmes such as the weekly "Thanzi la Onse" (Health of All) programme by Times Radio Malawi. We will formally present our trial results to Blantyre District Health Office and Malawi Ministry of Health. TRIAL REGISTRATION NUMBER: ISRCTN13836793.