The Breath project (Project Number: 2022-1-PL01-KA220-HED-000089283) has been Co-funded by the European Union. Views and opinions expressed are however those of the author or authors only and do not necessarily reflect those of the European Union or the Foundation for the Development of the Education System. Neither the European Union nor the entity providing the grant can be held responsible for them.

A feasibility randomised controlled trial of Novel Activity Management in severe Asthma-Tailored Exercise (NAMASTE): yoga and mindfulness.

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Institution
1 Centre of Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.
Institution Typology
University
Country
Australia
Description
Intervention design: Over 12-weeks, adults with severe asthma were recruited. Participants were randomised 2:1 to parallel yoga or control groups. All participants received an activity tracker.
The yoga group participated in two supervised 75-min group classes of yoga and mindfulness per week for 16-weeks in a private room during office hours (up to 8 participants/class), in addition to usual care. An accredited yoga practitioner designed and delivered the programme, in collaboration with the investigator team. Classes focused on increasing movement, controlling breath, and meditation to improve mindfulness, and were designed to be suitable regardless of experience, ability and physical limitations. The instructor explained how to perform the exercises, described precautions and encouraged participants to apply the lessons at home. Participants were advised to self-administer salbutamol before sessions to prevent exercise-induced bronchospasm. At their first class participants received an activity tracker (Fitbit Charge 2 [Fitbit, Inc], or pedometer for participants without smartphones) and were encouraged to progressively increase their daily steps according to an algorithm, up to 10,000 steps/day. Participants were also given information sheets (physical activity guidelines, SMART goal-setting, exercise and severe asthma and mindfulness), a printed calendar to track their activity goals, and a BORG Dyspnoea Scale to monitor dyspnoea during physical activity.
The control group received a minimal physical activity goal-setting intervention supported through telephone contact with an exercise physiologist research officer, in addition to usual care. Participants were mailed their activity tracker, the same printed documents as the yoga group, and a workbook to record goals and progress.
People involved: Participants were recruited via the John Hunter Hospital Department of Respiratory and Sleep Medicine’s ambulatory care clinics and research database, and via general/social media advertisement. G1: 15 (yoga) G2: 8 (control); Age: G1: 67 (±9), G2: 68 (±8). The inclusion criteria were: adults (≥ 18 years) with evidence of variable airflow limitation in the last 10 years (bronchodilator response≥ 12% or airway hyper-responsiveness or peak flow diary (variation ≥ 15% or > 50 ml), and severe asthma according to the European Respiratory Society (ERS)/American Thoracic Society (ATS) taskforce definition: asthma requiring high-dose inhaled corticosteroids (> 1000 μgbeclomethasone equivalent ) with a second controller to prevent uncontrolled disease or disease that remains uncontrolled despite therapy.
Identified barriers: Participants entered the study knowing the intervention was a yoga trial, which may have led to selection bias in the type of participants who volunteered. Furthermore, participants knew their group allocation, which may have led to bias in participant response to outcome questionnaires. To reduce these risks, both groups were informed that the effect of this intervention is unknown, and that true equipoise exists.
Sustainability
Transferability: asthma patients in all countries

Disease
Asthma
Activity level
Medium
Activity Typology
Rehabilitation section-based activities
Motivation Tools
Not available

Innovation
The study examines health-related quality of life in patients with severe asthma

Evaluation System
Primary outcome: St George’s Respiratory Questionnaire (SGRQ) [25], a valid self-reported health-related quality of life measure in severe asthma.

Secondary outcomes: Asthma Control Questionnaire-5 (ACQ-5), high sensitivity C-reactive protein, fractional exhaled nitric oxide (FeNO), spirometry BMI, percentage body fat and percentage lean muscle mass, 6MWT, steps per day, and sedentary time, self-report measures: Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Hospital Anxiety and Depression Scale (HADS), Dyspnoea-12, EQ-5D to assess health status, Cognitive and Affective Mindfulness Scale-Revise (CAMS-R), Friendship Scale (FS). Charlson Comorbidity Index (CCI) was calculated from self-reported medical history.

The study included two groups: Intervention group and control group


Assessment
A yoga and mindfulness intervention is feasible, acceptable and improved health-related quality of life for people with severe asthma.From the patient’s perspective, exercise interventions for people with severe asthma may benefit from incorporating opportunities for social connection, having a flexible programme structure, incorporating a shift in mindset, addressing breathing and asthma symptoms, and having multiple synergistic components. Studies to improve physical activity among people with severe asthma are needed, and this study is important in informing the design of future research.
References
Hiles SA, Urroz PD, Gibson PG, Bogdanovs A, McDonald VM. A feasibility randomised controlled trial of Novel Activity Management in severe ASthma-Tailored Exercise (NAMASTE): yoga and mindfulness. BMC Pulm Med. 2021;21(1):71. doi:10.1186/s12890-021-01436-3

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