ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001914257

Ethics application status

Approved

Date submitted

19/11/2018

Date registered

26/11/2018

Date last updated

1/11/2019

Date data sharing statement initially provided

26/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Novel Activity Management in severe ASthma - Tailored Exercise (NAMASTE): Yoga and Mindfulness.

Scientific title

A randomised controlled trial comparing yoga and mindfulness classes with a brief attention control on health-related quality of life in severe asthma.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

NAMASTE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Severe Asthma

Condition category

Condition code

Respiratory

Asthma

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

Treatment: Other

Comparator / control treatment

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 standard care as supplied in everyday practice for severe asthma. Written information is adapted from existing resources (e.g. Asthma Australia, Lung Foundation Australia, Health Direct). They will receive an activity tracker and be asked to increase their steps each day until the 10,000 steps/day goal is attained. 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. A research officer will telephone the control group participants for 10-15 minutes once every two weeks to assist with goal setting using the SMART method followed by assessing progress and conduct motivational interviewing.

Control group

Active

Outcomes

Primary outcome [1]

Health-related quality of life assessed using St George’s Respiratory Questionnaire (SGRQ).

Timepoint [1]