None listed
Conditions
Brief summary
We hypothesize that engagement in yoga and mindfulness will lead to significant improvements in quality of life and other important clinical outcomes including activity and psychological status in individuals diagnosed with severe asthma. A total of 54 adults (>=18yrs) that have stable severe asthma and will be recruited and randomly allocated to the NAMASTE yoga intervention group or control group. Participants randomised to the intervention group will participate in two supervised classes of yoga and mindfulness per week for 16 weeks. Participants randomised to the control group will receive written information about physical activity, mindfulness and goal-setting after their baseline assessment, in addition to usual care. All participants will also receive an activity tracker and be encouraged to increase their daily steps each day.
Interventions
Participants randomised to the intervention group will participate in two supervised 75-minute classes of yoga and mindfulness per week for 16 weeks in a private meeting room at the Hunter Medical Research Institute, in addition to usual care. Classes will be mixed-gender. The sessions will be taught by an accredited yoga practitioner with a first aid certificate and will be designed to consider the needs of people with severe asthma. The yoga intervention has been designed so that is suitable for all participants regardless of experience, ability and physical limitations. The classes provide the opportunity for participants to practice within the classes, to learn the practices, then to take and apply what they have learnt within their home environment. The classes will focus on three key concepts, increasing movement, controlling breath and meditation activities to improvement mindfulness 1.Asana (Movement - physical practices): The postures will include forward bends, back bends, side bends and spinal twists in standing, sitting or lying positions. Balancing practices are included to develop strength, confidence, stability, focus and a sense of calm. A ‘Flow’ of practices will be taught individually and then put together in a gentle, moving sequence. 2.Pranayama (Breath): A series of simple breathing practices will be taught with the intention of deepening the ‘yogic’ experience rather than any real focus on alleviating asthma related issues. Practices such as abdominal breathing, thoracic breathing, full yogic breath (a combination of abdominal and thoracic), ujjayi breath and alternate nostril breathing to bring awareness, balance, focus and calm to an individuals practice. 3.Meditation (focus, concentration, relaxation, stillness, awareness): The meditation practices are an extension of the posture and breathing practices. These practices will include observing of the natural breath, counting the breath, the layering of mental anchors to still and focus the mind. A guided, relaxation practice of Yoga nidra will be performed lying comfortably on the floor. It will start as a 10 minute practice, evolving into a full, 30 minute practice of deep relaxation. Participants will receive instruction on how to perform the yoga exercises and precautions for participating in each exercise throughout the class. Before starting each yoga class, the yoga instructor will ask participants whether they have any current illness or injury that may affect their participation in the class. Unwell participants will be referred to the clinical research officer who will perform additional monitoring of vital signs and referral, if necessary. Portable oxygen is also available if required. An experienced clinical researcher will be present at the start and end of the yoga sessions to record attendance, monitor participant’s ability to participate in the class and be on call throughout the session in case of adverse events. Participants will also receive an activity tracker and be encouraged to increase their daily steps each day until they reach a goal of 10,000 steps/day. The aim is to increase steps per day, but not necessarily reach the 10,000 step/day goal. The Mendoza algorithm for step progression will be used to assist participants in creating their own strategy and targets of increasing their steps per day.
Sponsors
Study design
Eligibility
Inclusion criteria
1. 18 years of age or older. 2. Evidence of variable airflow limitation in the last 10 years. 3. Severe asthma meeting the European Respiratory Society/American Thoracic Society taskforce definition: asthma requiring high-dose inhaled corticosteroids (>1000µg beclomethasone equivalent) with a second controller to prevent “uncontrolled” disease or disease that remains “uncontrolled” despite therapy.
Exclusion criteria
1. Pregnant. 2. High dependence on medical care. 3. Significant life-limiting comorbidity. 4. Current lung cancer or other blood, lymphatic or solid organ malignancy. 5. Primary diagnosis of a lung disease other than asthma. 6. Cognitive impairment, poor English language skills or significant untreated hearing impairment that prevents completion of data collection forms or understanding verbal instructions. 7. Inability to attend study visits or intervention classes. 8. Current participation in any other clinical trial. 9. Exacerbation (use of oral corticosteroids or an increase from maintenance dose of oral corticosteroids for >=3 days) in the previous four weeks. These participants will have their baseline visit postponed. 10. Comorbidity that would place the individual at substantial risk of harm or interfere with their ability to participate in the intervention.