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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
26/11/2018
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] 296476 0
Nil
Universal Trial Number (UTN)
Trial acronym
NAMASTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Asthma 310262 0
Condition category
Condition code
Respiratory 308992 308992 0 0
Asthma
Physical Medicine / Rehabilitation 309229 309229 0 0
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] 312808 0
Behaviour
Intervention code [2] 312809 0
Lifestyle
Intervention code [3] 312995 0
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] 307960 0
Health-related quality of life assessed using St George’s Respiratory Questionnaire (SGRQ).
Timepoint [1] 307960 0
16 weeks post-commencement of intervention
Secondary outcome [1] 353472 0
Asthma symptom control: Patient-reported Asthma Control Questionnaire, a validated questionnaire in severe asthma (ACQ)
Timepoint [1] 353472 0
16 weeks post-commencement of intervention
Secondary outcome [2] 353481 0
Physical activity: Patient-reported via the International Physical Activity Questionnaire (IPAQ)
Timepoint [2] 353481 0
16 weeks post-commencement of intervention
Secondary outcome [3] 353483 0
Anxiety and depression: Patient-reported Hospital and Anxiety Depression Scale (HADS)
Timepoint [3] 353483 0
16 weeks post-commencement of intervention
Secondary outcome [4] 353484 0
Dyspnoea: Patient reported with the Dyspnoea-12 questionnaire
Timepoint [4] 353484 0
16 weeks post-commencement of intervention

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will undergo their baseline assessment and will be deemed eligible for the study prior to randomisation. Concealed random allocation will be employed using an online randomisation system, with allocations made by a statistician independent of the study team. A research officer will relay the allocations to the participants over the telephone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to intervention or control groups using an online randomisation system with a 2:1 allocation in three blocks, stratified by gender
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A mixed repeated measures generalised linear model will be conducted, with the primary outcome as SGRQ. Data will be analysed on an intention-to-treat basis. Missing outcome data will be taken into account via restricted maximum likelihood mixed model analysis. Sensitivity analyses using multiple imputation by chained equations will also be completed. Tests will be two-sided with p < 0.05 considered statistically significant. Secondary outcomes will also be assessed using the same method,

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12319 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 12320 0
Hunter Medical Research Institute - New Lambton Heights
Recruitment postcode(s) [1] 24556 0
2305 - New Lambton
Recruitment postcode(s) [2] 24557 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 301066 0
Charities/Societies/Foundations
Name [1] 301066 0
John Hunter Hospital Charitable Trust
Address [1] 301066 0
Lookout Rd, New Lambton Heights NSW 2305
Country [1] 301066 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 300684 0
None
Name [1] 300684 0
Address [1] 300684 0
Country [1] 300684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301821 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301821 0
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 301821 0
Australia
Date submitted for ethics approval [1] 301821 0
Approval date [1] 301821 0
24/10/2018
Ethics approval number [1] 301821 0
18/09/19/4.12

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88222 0
Prof Vanessa M McDonald
Address 88222 0
School of Nursing and Midwifery
Faculty of Health and Medicine
University of Newcastle
University Drive
Callaghan NSW 2308
Country 88222 0
Australia
Phone 88222 0
+61 2 40420146
Fax 88222 0
Email 88222 0
vanessa.mcdonald@newcastle.edu.au
Contact person for public queries
Name 88223 0
Miss Paola Urroz
Address 88223 0
School of Nursing and Midwifery
Faculty of Health and Medicine
University of Newcastle
University Drive
Callaghan NSW 2308
Country 88223 0
Australia
Phone 88223 0
+61 2 40420092
Fax 88223 0
Email 88223 0
paola.urroz@newcastle.edu.au
Contact person for scientific queries
Name 88224 0
Prof Vanessa M McDonald
Address 88224 0
School of Nursing and Midwifery
Faculty of Health and Medicine
University of Newcastle
University Drive
Callaghan NSW 2308
Country 88224 0
Australia
Phone 88224 0
+61 2 40420146
Fax 88224 0
Email 88224 0
vanessa.mcdonald@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable