Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001264875
Ethics application status
Approved
Date submitted
29/11/2012
Date registered
3/12/2012
Date last updated
3/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to evaluate the impact of a nurse delivered in-patient pulmonary programme for people in the post-acute phase of stroke recovery.
Scientific title
A randomised controlled trial to evaluate the impact of a nurse delivered in-patient pulmonary programme for people in the post-acute phase of stroke recovery.
Secondary ID [1] 281613 0
Nil
Universal Trial Number (UTN)
U1111-1137-4533
Trial acronym
NDPP Nurse Delivered Pulmonary Programme
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory muscle weakness following stroke 287885 0
Respiratory 287891 0
Condition category
Condition code
Stroke 288257 288257 0 0
Ischaemic
Stroke 288258 288258 0 0
Haemorrhagic
Respiratory 288269 288269 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 patients in the intervention group who will receive the intended pulmonary rehabilitation programme together with the usual standard stroke care, and 30 patients in the control group who will receive the usual standard stroke care. The respiratory intervention of incentive spirometry and or the active cycle of breathing technique will be delivered three times a day five days a week whilst an inpatient by the Principle Investigator or the Nurse Educator . The intervention takes approximately 15 minutes to perform. The participant and significant other will be educated in continuing the programme once discharged home. They will be supported by telephone to continue the programme and keep a diary until followed up in an outpatient clinic six weeks post initiation of the intervention.
Inclusion and exclusion criteria will be applied to exert control over extraneous variables. A single-blind approach will be used.

Interventions:
1. Incentive spirometry - inspiratory muscle training
2. Active Cycle of Breathing technique

1. Incentive spirometers are used to promote deep breathing. They measure the flow of air inhaled through the mouthpiece and enhance pulmonary ventilation, overcome the effects of hypoventilation, loosen respiratory secretions, assist respiratory gas exchange and help with the re-expansion of collapsed alveoli. Incentive spirometry is designed to mimic natural sighing or yawning by encouraging the patient to take long, slow, deep breaths. This decreases pleural pressure, promoting increased lung expansion and better gas exchange (Davis, 2012).
Risks associated with insentive spirometry:
1). Fatigue
2). Hyperventilation
3). Ineffective unless performed as instructed
(Restrepo, Wettstein, Wittnebel & Tracy, 2011).

2. Active Cycle of Breathing technique
The active cycle of breathing technique has three parts to it:
1). Breathing control
2). Deep breathing exercises
3). Huffing (Lewis, Williams & Olds, 2012)
The Active Cycle of Breathing technique has been shown to be an effective treatment in improving pulmonary function, airway clearance and oxygenation in chronic obstructive pulmonary disease, cystic fibrosis and acute respiratory failure. This technique is commonly used for the prophylaxis and treatment of respiratory complications in post-surgical patients and has been found to be effective (Lewis, Williams & Olds, 2011).
Risks associated with the Active Cycle of Breathing technique:
1). Fatigue
Intervention code [1] 286134 0
Rehabilitation
Comparator / control treatment
Both the control and the intervention groups will receive standard, evidence-based stroke care as directed by national stroke guidelines. Usual standard stroke care involves symptom management, activities of daily living, mobilisation, swallow precautions, nutritional support, psychosocial support and physical therapy/exercises carried out on a regular basis by the rehabilitation physician and junior doctors, nurses, physiotherapist, occupational therapist, therapy assistants, speech language therapist, social worker and dietician.

The stroke rehabilitation medical team review the patients on the unit on a daily basis and support appropriate care and intervention of these patients.

Nurses provide 24 hour patient care that includes careful monitoring of signs and symptoms of health status and changes that require management, prevention of complications of immobility including pressure areas, bladder and bowel, nutritional and fluid maintenance. Early mobilisation into a stroke chair within 24 hours of the stroke is standard practice and is supported by the whole team involved.

The stroke patient is assessed by the physiotherapist and occupational therapist within 72 hours of admission to the stroke unit. During the inpatient episode the stroke patient receives at least one hour a day of active, hands-on therapy five days a week that involves the physiotherapist and occupational therapist/ therapy assistant. The therapy includes mobilisation, an exercise programme, activities of daily living i.e. therapy that involves useful tasks such as showering, dressing, social interaction, use of assistive devices, kitchen tasks etc.

The speech language therapist will assess the safety of swallow of the stroke patient within 24 hours of admission to the stroke unit, advise on appropriate food and fluid textures. The speech language therapist will work with the patient on a daily basis if required or tailor the programme to meet the specific needs of the patient. Therapy offered includes swallow and communication tasks and strategies.

The stroke patient is assessed by a dietician within 24 hours of admission to the stroke unit and she will review the patient on a regular basis depending on the level of need. The dietician supports optimal nutritional intake and fluid balance throughout the inpatient episode.

The social worker will review the patient and family within 72 hours of admission and provide ongoing support depending on the need of the patient and the family.

At discharge from the stroke unit referral is made to community services to continue the rehabilitation programme. The patient is again reviewed in the stroke rehabilitation clinic 6 weeks following discharge to review rehabilitation needs.
Control group
Active

Outcomes
Primary outcome [1] 288438 0
Increased respiratory muscle strength indicated on spirometric measures.
Spirometry and measurement of respiratory muscle strength (Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), Maximal Inspiratory Pulmonary function (MIPs) and Maximal Expiratory Pulmonary function (MEPs)
Timepoint [1] 288438 0
The period of follow-up will last six weeks. Data will be collected at baseline, at two weeks post randomisation and again at six weeks post randomisation. The data will be collected by a research associate. Timepoints: (weeks) 0, 2weeks, 6 weeks.
Secondary outcome [1] 300163 0
1. Reduction of fatigue
Fatigue Impact Scale - Assessment of the impact of fatigue on daily activities.
Clinical assessement will be performed prior to the intervention. This will include pulse rate, blood pressure (sphygonometer) and oxygen saturation level using a pulse oximeter.
Timepoint [1] 300163 0
The period of follow-up will last six weeks. Data will be collected at baseline, at two weeks post randomisation and again at six weeks post randomisation. The data will be collected by a research associate. Timepoints: (weeks) 0, 2weeks, 6 weeks.
Secondary outcome [2] 300164 0
2. Increased participation in daily rehabilitation programme. Daily measurement of time spent in active therapy will be recorded.
Timepoint [2] 300164 0
The period of follow-up will last six weeks. Data will be collected at baseline, at two weeks post randomisation and again at six weeks post randomisation. The data will be collected by a research associate. Timepoints: (weeks) 0, 2weeks, 6 weeks.
Secondary outcome [3] 300165 0
3. Reduction in the incidence of pneumonia and atelectasis.
Chest infection will be defined as temperature greater than 37.5 degrees Celcius on two consecutive measurements or a single measurement of temperature greater than 38.0 degrees Celcius with chest symptoms and one or more of the following: white cell count more than 11 000/mL, pulmonary infiltrate on chest x-ray and positive microbiology culture.
Timepoint [3] 300165 0
Daily evaluation
Secondary outcome [4] 300166 0
4. Quality of Life. Euroqual- 5D tool. Standardised measure of health status providing quatitative measure of health outcome
Timepoint [4] 300166 0
The period of follow-up will last six weeks. Data will be collected at baseline, at two weeks post randomisation and again at six weeks post randomisation. The data will be collected by a research associate. Timepoints: (weeks) 0, 2weeks, 6 weeks.
Secondary outcome [5] 300167 0
5. BORG Rating of Perceived Exertion Scale. Measure of physical activity intensity level.
Timepoint [5] 300167 0
The period of follow-up will last six weeks. Data will be collected at baseline, at two weeks post randomisation and again at six weeks post randomisation. The data will be collected by a research associate. Timepoints: (weeks) 0, 2weeks, 6 weeks.
Secondary outcome [6] 300168 0
Functional Independence Measure provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living
Timepoint [6] 300168 0
Data will be collected at baseline and again at six weeks post randomisation.

Eligibility
Key inclusion criteria
1. Ischaemic or haemorrhagic stroke patients confirmed on imaging, presenting with any symptoms of dysphasia, dysphagia, hemiplegia and has the ability to form a mouth seal to perform spirometry;
2. 55 years of age or older;
3. National Institute Health Stroke Score (NIHSS) between 5-20 and considered suitable for inpatient rehabilitation;
4. Able to engage in a respiratory programme;
5. All participants or their main caregiver must provide and be capable of providing a declaration of Informed Consent;
6. All participants must be English-speaking or provide a family member who can act as an interpreter;
7. Medically stable with potential for improvement; and
8. Male and female, ethnicity.
Minimum age
55 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Medically unstable patients;
2. Unable to give consent or refusing consent;
3. Unable to follow simple commands or instructions;
4. Impaired level of consciousness; and
5. Evidence of significant cognitive impairment (AMTS lower or equal to 7/10).

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)
1. Stroke patients on the comprehensive stroke unit identified by the stroke physician as meeting the entry criteria will be approached by the Nurse Educator and asked whether they would be interested in participating in the study. The person and significant other will be provided with a simple patient information sheet that will outline the study, a discussion will be had to answer any questions and the consent form together with the patient information sheet will be left with the patient to allow time for decision making. The Nurse Educator does not participate in the daily care of the stroke patients thus removing the element of coercion that would exist if she did.
2. All stroke patients admitted to the stroke unit have a complete medical assessment including medical history, physical and neurological examination, National Institute of Health Stroke Scale (NIHSS), resting 12-lead electrocardiogram (ECG), 24-48 hour cardiac monitoring and routine serum analysis.
3. Once consent is gained, baseline spirometry will be carried out in the laboratory and patients will be randomly assigned to either the intervention or the control group at this time. The respiratory technition will be given sealed envelopes by the Primary Investigator with the randomised computerised sequence generated number. The technition will hand the envelope to the Primary Investigator or the nurse educator at the time of the respiratory test to allow for randomisation.
4. The respiratory technician will be blinded to allocation. Assignment to either the intervention group or control group will be made using a simple randomisation technique. A randomisation table created by computerised sequence generation to either group A – intervention group, or group B – control group will be utilised. The Primary Investigator and her two team members (lead physiotherapist and nurse educator) will know who has been assigned to the intervention group to ensure that only this group receive the study interventions.
Each stroke patient will have an equal chance of being selected for the sample once they have met the inclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assignment to either the intervention group or control group will be made using a simple randomisation technique. A randomisation table created by computerised sequence generation to either group A – intervention group, or group B – control group will be utilised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single-blind, two-arm randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 286412 0
Hospital
Name [1] 286412 0
Waikato District Health Board
Country [1] 286412 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland
1142
Country
New Zealand
Secondary sponsor category [1] 285194 0
Individual
Name [1] 285194 0
Professor Matthew Parsons
Address [1] 285194 0
University of Auckland
Level 2 Building 505
85 Park Road
Auckland
1142
Country [1] 285194 0
New Zealand
Secondary sponsor category [2] 285202 0
Individual
Name [2] 285202 0
Dr Michael Kaplan
Address [2] 285202 0
Consultant Rehabilitation Physician
Private Bag 3200
Waikato District Health Board
Hamilton
3240
Country [2] 285202 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288492 0
Kaumatua Kaunihera Ethics Research Committee
Ethics committee address [1] 288492 0
Private Bag 3200
Hamilton
3244
Ethics committee country [1] 288492 0
New Zealand
Date submitted for ethics approval [1] 288492 0
04/12/2012
Approval date [1] 288492 0
13/11/2012
Ethics approval number [1] 288492 0
Application to be made on the 04/12/2012

Summary
Brief summary
The stroke population frequently present with a number of risk factors including smoking, central obesity, obstructive sleep apnoea, cardiovascular disease, chronic respiratory disease and a sedentary lifestyle. These subsequently contribute to poor outcomes following stroke. Compelling evidence of benefit and cost-effectiveness has been identified in the literature to support pulmonary rehabilitation in chronic respiratory diseases. No large studies were identified that targeted stroke patients specifically, even though a large volume of evidence exists in regards to the impact of stroke on respiratory function, fatigue and exercise tolerance The proposed programme is simple to deliver, requires limited resources, takes fifteen minutes to deliver and can be done as part of the routine care delivered to the patient. This ultimately will increase vigilance from nursing in regards to the impact of respiratory muscle weakness following stroke and support patient self management in the sub-acute phase of stroke, and in the long term rehabilitation process in the home environment. Patient education is a core component to the success of this project. Nursing plays a pivotal role within the interdisciplinary team in supporting patient self management skills in all aspects of the individuals’ health needs post stroke. Pulmonary rehabilitation and well-being is a fundamental step in the reduction of complications following a stroke and in improving long term outcomes.

Nurses play a pivotal role in all phases of care in the stroke patient and are present 24 hours a day. The proposed pulmonary rehabilitation interventions build on previous work but embed it within Nursing and therefore if successful can be readily introduced by nursing staff. This positions them well to play an active role in supporting pulmonary rehabilitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34996 0
Address 34996 0
Country 34996 0
Phone 34996 0
Fax 34996 0
Email 34996 0
Contact person for public queries
Name 18243 0
Pat Simpson
Address 18243 0
Private Bag 3200
Hamilton
3244
Country 18243 0
New Zealand
Phone 18243 0
+64 7 8398899
Fax 18243 0
Email 18243 0
[email protected]
Contact person for scientific queries
Name 9171 0
Pat Simpson
Address 9171 0
Private Bag 3200
Hamilton
3244
Country 9171 0
New Zealand
Phone 9171 0
+64 7 8398899
Fax 9171 0
Email 9171 0
[email protected]

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No Supporting Document Provided



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