Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000737235
Ethics application status
Approved
Date submitted
17/08/2009
Date registered
25/08/2009
Date last updated
25/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an in-hospital exercise group for respiratory patients and physiotherapy care.
Scientific title
The effect of a twice weekly inpatient exercise group and standard physiotherapy care of respiratory patients on uptake of Pulmonary Rehabilitation, physical activity levels and Quality of Life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exacerbation of Chronic Obstructive Pulmonary Disease 243529 0
Condition category
Condition code
Respiratory 239829 239829 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard Physiotherapy care including mobilisation and airway clearance techniques and education as appropriate. Prescription based on individual needs.

Exercise Class including thoracic mobilisation exercises, Upper Limb strengthening exercises, education and cariovascular exercises. Prescription based on individual needs.
Intervention code [1] 241138 0
Treatment: Other
Intervention code [2] 241178 0
Lifestyle
Intervention code [3] 241179 0
Rehabilitation
Comparator / control treatment
Control treatment consists of Standard Physiotherapy care including mobilisation and airway clearance techniques and education as appropriate. Prescription based on individual needs.
Control group
Active

Outcomes
Primary outcome [1] 240592 0
Attendance at Pulmonary Rehabilitation
Timepoint [1] 240592 0
12 weeks post discharge from acute hospital setting
Secondary outcome [1] 257222 0
Health Related Quality of Life as measured on the Chronic Respiratory Disease Questionnaire
Timepoint [1] 257222 0
12 weeks post discharge from acute hospital setting
Secondary outcome [2] 257223 0
Physical Activity Levels as based on the Six Minute Walk Test
Timepoint [2] 257223 0
12 weeks post discharge from acute hospital setting

Eligibility
Key inclusion criteria
Admitted with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Be located on 44N / 44S
Be admitted under the respiratory
Be medically stable
Blood Pressure appropriate for mobilisation (ie > 100)
Heart Rate appropriate for mobilisation (ie <120)
Oxygen Saturation (SpO2) >or = 90% or within acceptable range documented by medical staff with or without oxygen
Oxygen < or = 4L O2 / min via Nasal Prongs (NP)
Deemed appropriate by the treating unit to attend the group
Be eligible to attend outpatient Pulmonary Rehabilitation classes following discharge
Be able to transfer with supervision or minimal assistance + / - gait aid
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Do not meet the medically stable criteria as listed above
Have been admitted from a Nursing Home,
Do not have a basic understanding of both spoken and written English to be able to communicate effectively within the group session and understand the written information given (Respiratory Home Exercise Program Booklet).

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)
The principal researcher will be responsible for identifying eligible participants based on hospital admission diagnosis, and other inclusion criteria as discussed previously. At this time, the principal researcher will be unaware to which group the participant will be allocated to.

After providing informed consent, the independent recruitor will collect initial data Unit Record (UR) number, age, sex, relevant past medical history, and admission diagnosis.
Consenting participants will be randomly allocated to the exercise or control group. Allocation will be determined using computer generated allocation sequence and recorded and concealed until the participant has been admitted to the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated allocation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237511 0
Hospital
Name [1] 237511 0
Southern Health, Monash Medical Centre
Country [1] 237511 0
Australia
Primary sponsor type
Individual
Name
Alison Fisher
Address
Monash Medical Centre
Clayton Road
Clayton
Vic 3168
Country
Australia
Secondary sponsor category [1] 236990 0
None
Name [1] 236990 0
Address [1] 236990 0
Country [1] 236990 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243641 0
Southern Health Human Ethics Research
Ethics committee address [1] 243641 0
Monash Medical Centre
Clayton Road
Clayton
Vic 3168
Ethics committee country [1] 243641 0
Australia
Date submitted for ethics approval [1] 243641 0
Approval date [1] 243641 0
21/07/2009
Ethics approval number [1] 243641 0
09181B

Summary
Brief summary
The project will investigate the effect of a twice weekly inpatient exercise group and standard physiotherapy care of respiratory patients on uptake of Pulmonary Rehabilitation, physical activity levels, and Quality of Life.
Participants who are admitted with an acute exacerbation of Chronic Obstructive Pulmonary Disease and located on 44 South or 44North, deemed able to exercise by the treating medical unit and able to participate in the group by the treating physiotherapist will be randomised into either the control or exercise group.
The Grade One Physiotherapist who is not attached to either the Respiratory or General Medical Units will collect participant characteristics (age, COPD severity, Lung Function Test if available and admission dates), and questionnaire data once recruited to the project. Participants will then be randomized into control group (where they will receive standard physiotherapy treatment) or exercise group (where they will attend the “Fit to Breathe Group” as well as receiving standard physiotherapy treatment).
At discharge, discharge destination, questionnaire data (Chronic Respiratory Disease Questionnaire), physical activity levels (6MWT) and length of stay data will be collected.
On discharge, all participants will receive Pulmonary Rehabilitation Referrals and the Respiratory Home Exercise Booklet and completed Home Exercise Program.
All participants will return for follow up assessment 12 weeks following discharge. At this assessment, 6MWT and the Chronic Respiratory Questionnaire will be repeated. The Pulmonary Rehabilitation coordinators will also be contacted to determine attendance at Pulmonary Rehabilitation. All patient information will be kept in the locked filing cabinet in the physiotherapy department.
All data will be collected by the Grade One physiotherapist and entered into a password-protected Microsoft excel table. Participant review dates will be recorded in the 2009 A4 diary which will also be kept in this filing cabinet.

Differences in the proportion of participants who undertake outpatient Pulmonary Rehabilitation will be examined using chi squared test. Repeated measures analysis of variance will be used to examine differences in physical activity, 6-minute walk and quality of life data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30059 0
Address 30059 0
Country 30059 0
Phone 30059 0
Fax 30059 0
Email 30059 0
Contact person for public queries
Name 13306 0
Alison Fisher
Address 13306 0
Physiotherapy Department
Monash Medical Centre
Clayton Road
Clayton
Vic 3168
Country 13306 0
Australia
Phone 13306 0
+61 03 9594 6666
Fax 13306 0
Email 13306 0
[email protected]
Contact person for scientific queries
Name 4234 0
Alison Fisher
Address 4234 0
Physiotherapy Department
Monash Medical Centre
Clayton Road
Clayton
Vic 3168
Country 4234 0
Australia
Phone 4234 0
+61 03 9594 6666
Fax 4234 0
Email 4234 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.