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Trial registered on ANZCTR


Registration number
ACTRN12608000605392
Ethics application status
Not yet submitted
Date submitted
16/11/2008
Date registered
3/12/2008
Date last updated
3/12/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase 1 trial of exercise for patients admitted to hospital with acute exacerbation of chronic obstructive pulmonary disease (COPD)
Scientific title
A phase 1 trial of exercise for patients admitted to hospital with acute exacerbation of chronic obstructive pulmonary disease (COPD)- the safety and feasibility of exercise programme.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute exacerbation of COPD 4050 0
Condition category
Condition code
Respiratory 4256 4256 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group 1: Routine care (similiar to control group) with the addition of two fifteen minutes exercise session per day from the second day of admission to day of discharge. The exercise programme will include a walking programme and strengthening exercise. Participants in this group will be required to cover 70% of the distance that they achieve during the 3 minute walk test at initial assessment and perform 8-10 repetitions of each of the strengthening exercises.

Intervention group 2: Routine care in addition of identical exercise programme performed in intervention group 1 from second day of admission to day of discharge. However, participants in this group are only required to cover 40% of their distance achieved during their initial three minute walk test and perform 20-25 repetitions of each of the strengthening exercises.
Intervention code [1] 3772 0
Treatment: Other
Comparator / control treatment
Standard care: Routine medical, nursing and physiotherapy care for patients who presented with an acute exacerbation of COPD. The duration of standard care will occur during their inpatient admission.
Control group
Active

Outcomes
Primary outcome [1] 5072 0
number of adverse events will be assessed. Events will be classified as an adverse event when the conditions below occur
All adverse events are categorised into adverse physiological incident and adverse physiological changes. Adverse physiological incident refers to an occurrence of one or more adverse physiological changes as a result of one physiotherapy treatment. Examples of adverse physiological incidents include death, acute myocardial infarct, myocarditis, respiratory distress, ventricular arrhythmias, vaso-vagal episodes, collapse and acute musculoskeletal aches and pain. On the other hand, adverse physiological changes refer to change in vital signs during physiotherapy intervention and ten minutes after physiotherapy. The details are as below:

Blood pressure:An alteration in systolic blood pressure > or < 20% of resting value.

Heart rate:>85% of theorized maximum HR calculated by taking 85% of 220- age of patient

Oxygen saturation:Decrease in SpO2 >10% or one which necessitates ceasing treatment (SpO2 <88% on 15lpm or FiO2 of 50%)

Fall that has occurred during the treatment

Systematic signs such as breaking out into cold sweat, complaining of heart palpitations, increasing in rate of respiration to >25 breaths per minute.
Timepoint [1] 5072 0
Adverse events are assessed during and at the end of each exercise session daily
Primary outcome [2] 5073 0
Change in patient's rating on perceived level of shortness of breath as per the Borg score
Timepoint [2] 5073 0
Before the commencement of the exercise programme and two minutes post exercise programme each day
Primary outcome [3] 5074 0
Change in vital signs that include oxygen saturation, blood pressure and heart rate as measured by a portable pulse oxymeter and blood pressure cuff
Timepoint [3] 5074 0
Beginning and two minute post exercise after each exercise session
Secondary outcome [1] 8524 0
Change in distance in 3 minute walk test to measure changes in exercise tolerance
Timepoint [1] 8524 0
At baseline and on the day of discharge
Secondary outcome [2] 8526 0
Difference in length of stay between three groups by looking at the hospital record regarding number of days of admission
Timepoint [2] 8526 0
Length of stay will be recorded on the day of discharge
Secondary outcome [3] 8650 0
Number of drop outs as classified as the number of participants who refuse to continue to participate in the exercise programme during their inpatient stay
Timepoint [3] 8650 0
From second day of admission to day of discharge
Secondary outcome [4] 8651 0
Change in muscle strength of arms and legs as measured by a hand held dynanometer
Timepoint [4] 8651 0
At baseline and on day of discharge
Secondary outcome [5] 8652 0
Change in lung function in particular minute ventilation and forced expiratory volume in one second as measured by a portable lung spirometry
Timepoint [5] 8652 0
At baseline and on the day of discharge
Secondary outcome [6] 8653 0
Change in global rate of change scale to measure the changes in patient's perceived change in lung function and symptoms after completion of exercise programme
Timepoint [6] 8653 0
On the day of discharge
Secondary outcome [7] 8654 0
Change in Barthel index that measures the level of function of patients in terms of ability to transfer and ambulate
Timepoint [7] 8654 0
At baseline and on the day of discharge

Eligibility
Key inclusion criteria
1. A primary admission diagnosis of acute exacerbation of COPD, or pneumonia or chest infection with a past medical history of COPD
- All levels of severity will be considered
2. Able to ambulate independently or with minimal assistance of one person with/without a gait aid.
3. Able to obey two-stage commands, obtain a score of 15 on the Glasgow Coma Scale, be orientated to time, day and date and have no previous documented diagnosis of dementia
4. Patients are managed on the general medical wards.
5. Patients that are spontaneously ventilating and do not required any continuous assistance with ventilation.
6. Able to give informed consent to participate in the trial.
7. Must obtain approval of supervising medical officer that patient can participate in trial
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are clinically unstable as defined by below
- Presence of hyperthermia (temperature of =380 Celsius)
- Systolic pressure of <90 or >170mmHg
- Diastolic pressure of >120mmHg
- Unconscious or patients in a delirious state
- Patients with severe respiratory acidosis with a blood pH < 7.3 (McKenzie et al., 2007)
- Patients measured to have an acute cardiac arrhythmia during admission.
- Patients who are tachycardiac with a resting heart rate >120 beats per minute.
2. Patients with other co-morbidities that may impair the ability to participate in an exercise programme (for example severe osteoarthritis, severe neurological conditions with residual deficits, severe low back pain and acute musculoskeletal injuries).
3. Patients who are acutely confused and unable to follow simple instructions.
4. - Patients admitted to the intensive care unit.
- Patients admitted to short stay unit or Rapid Acute Medical Unit (RAMU)
5. Patients that required intubation and mechanical ventilation and/or admitted into intensive care.
6. Patients from a high-level or palliative care facility

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)
Potential participants will receive usual nursing and medical care on admission into Maroondah Hospital. The nursing unit manager of each ward will refer potential participants to routine ward physiotherapist who is not the principal researcher. The routine ward physiotherapist will ask if potential patients are interested to have more information about the research. The principal researcher will then approach the potential interested patients and will identify if the patient is able to participate in the project.
Upon identification, potential participants will be invited verbally to participate in the project by the principal researcher on the either the 1st or 2nd day of admission. They will be provided with a participant information and consent form. They will also require medical clearance from treating medical unit that participants are suitable to participate in the project and have the capacity to exercise.

Prior to commencement of the recruitment, research investigator (NT) will generate the block sequence. Thirty envelope will be generated using a concealed method. In each envelope, information on group allocation will be included and each participant will be assigned to a number in order of recruitment to the trial. Participants will only be allocated to their group after the assessor has completed baseline assessments. Allocation will be administered by the principal researcher to ensure blinding of the assessor to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants of this trial will be randomly allocated into one of the three groups (Control(CTRL), 40% exercise programme (EP) and 70% exercise programme (EP)) by applying the block randomisation method (Beller, Gebski, & Keech, 2002).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4175 0
Self funded/Unfunded
Name [1] 4175 0
Clarice Youci Tang
Country [1] 4175 0
Australia
Primary sponsor type
Individual
Name
Clarice Youci Tang
Address
Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
Country
Australia
Secondary sponsor category [1] 3748 0
Individual
Name [1] 3748 0
Professor Nicholas Taylor
Address [1] 3748 0
Education Centre
Peter James Centre
Locked Bag
PO Forest Hill 3131
Country [1] 3748 0
Australia
Other collaborator category [1] 479 0
Individual
Name [1] 479 0
Felicity Blackstock
Address [1] 479 0
La Trobe University
Bundoora Vic 3086
Country [1] 479 0
Australia
Other collaborator category [2] 480 0
Individual
Name [2] 480 0
Dr Michael Clarence
Address [2] 480 0
Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
Country [2] 480 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6229 0
Ethics committee address [1] 6229 0
Ethics committee country [1] 6229 0
Date submitted for ethics approval [1] 6229 0
24/11/2008
Approval date [1] 6229 0
Ethics approval number [1] 6229 0

Summary
Brief summary
The effects of the exercise programme in the pulmonary rehabilitation has been thoroughly evaluated on people who are in their stable stage of COPD and the training has been proven to be very beneficial to this population (Lacasse et al.2003, (Nicki et al., 2006), (Carter & Nicotra, 1996; Mink, 1997). Benefits of exercise training include improved sense of well-being, increase in muscle metabolic capacity, reduction in lactic acid and increase in cross section of muscle fibres (Nicki et al., 2006). However, there are no trial investigating the possibility of implementing the exercise programme for patients who have been admitted for acute exacerbation of COPD.

The primary aims of study is to investigate the safety and feasibility of implementing an exercise programme for patients with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) and also aim to establish the optimal intensity of exercise for in-patient exercise programme

An estimated number of 30 participants will be recruited and assessed on the 1st or 2nd day following admission with the intention of commencing intervention from 2nd day of admission up to day of discharge. Out of the three groups, one will be the control group that received standard care and the other two will participate in a twice-daily 15 minutes exercise sessions during the trial duration in addition of standard physiotherapy treatment that the control group will be receiving. The two exercise groups will be exercising at either 40% or 70% maximal output intensity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29135 0
Address 29135 0
Country 29135 0
Phone 29135 0
Fax 29135 0
Email 29135 0
Contact person for public queries
Name 12292 0
Clarice Youci Tang
Address 12292 0
Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
Country 12292 0
Australia
Phone 12292 0
+61 (03) 9871 3502
Fax 12292 0
Email 12292 0
[email protected]
Contact person for scientific queries
Name 3220 0
Clarice Youci Tang
Address 3220 0
Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
Country 3220 0
Australia
Phone 3220 0
+61 (03) 9871 3502
Fax 3220 0
Email 3220 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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