Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000369921
Ethics application status
Approved
Date submitted
4/04/2011
Date registered
11/04/2011
Date last updated
23/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical Activity Levels During and After an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
Physical Activity Levels During and After an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
Secondary ID [1] 259876 0
Nil
Universal Trial Number (UTN)
U1111-1120-4106
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). 265466 0
Stable Chronic Obstructive Pulmonary Disease (COPD). 265486 0
Condition category
Condition code
Physical Medicine / Rehabilitation 265621 265621 0 0
Physiotherapy
Physical Medicine / Rehabilitation 265637 265637 0 0
Other physical medicine / rehabilitation
Respiratory 265692 265692 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Observe physical activity during hospital stay from day 2 of hospital admission day to day 5 or until discharged.
2. Observe physical activity for one week at home from the day of discharge.
3. Observe physical activity for one week at home at 6 weeks following the day of admission.
The overall duratio n of patient recruitment to this observational study is 7 weeks.
Intervention code [1] 264298 0
Not applicable
Comparator / control treatment
no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262413 0
The primary outcome is average steps per day. This will be measured by the Sensewear Pro3 armband which is a motion sensor worn on the upper arm.
Timepoint [1] 262413 0
The steps per day will be averaged over three time points being hospitalisation, the first week at home and the week at home at the six week follow-up. The difference in the average steps per day across the time points will be compared with paired t-tests. A p-value of <0.05 will be taken as significant.
Primary outcome [2] 262428 0
Another primary outcome is average energy expenditure per day. This will be measured by the Sensewear Pro3 armband which is a motion sensor worn on the upper arm.
Timepoint [2] 262428 0
The average energy expenditure per day will be averaged over three time points being hospitalisation, the first week at home and the week at home at the six week follow-up. The difference in the average energy expenditure per day across the time points will be compared with paired t-tests. A p-value of <0.05 will be taken as significant.
Primary outcome [3] 262429 0
Another primary outcome is time spent in greater than 3 METs activity per day. This will be measured by the Sensewear Pro3 armband which is a motion sensor worn on the upper arm.
Timepoint [3] 262429 0
The average greater than 3 METs activity per day will be averaged over three time points being hospitalisation, the first week at home and the week at home at the six week follow-up. The difference in the average greater than 3 METs activity per day across the time points will be compared with paired t-tests. A p-value of <0.05 will be taken as significant.
Secondary outcome [1] 273735 0
Six minute walk distance from the six minute walk test where patients are asked to walk as far as possible in six minutes on a designated track.
Timepoint [1] 273735 0
Six minute walk distance will be measured over two time points being day 5 of hospitalisation and at the follow up (six weeks post day of admission).
Secondary outcome [2] 273753 0
Anxiety and Depression as measured by the Hospital Anxiety and Depression Scale.
Timepoint [2] 273753 0
Anxiety and Depression will be measured over two time points being day 5 of hospitalisation and at the follow up (six weeks post day of admission).
Secondary outcome [3] 273754 0
FEV1, FVC and FEV1/FVC ratio will be measured by spirometry.
Timepoint [3] 273754 0
FEV1, FVC and FEV1/FVC ratio will be measured over three time points at Day 2 of hospital admission, on the day of discharge from hospital and 6 weeks post the day of admission.
Secondary outcome [4] 273755 0
Dyspnoea will be measured by the MRC dyspnoea scale.
Timepoint [4] 273755 0
Dyspnoea will be measured over two time points being day 5 of hospitalisation and at the follow up (six weeks post day of admission).
Secondary outcome [5] 273756 0
COPD impact will be measured by COPD assessment test (CAT).
Timepoint [5] 273756 0
COPD impact will be measured over two time points being day 5 of hospitalisation and at the follow up (six weeks post day of admission).
Secondary outcome [6] 273894 0
Armband comfort will be measured by Armband Comfort Survey
Timepoint [6] 273894 0
We would like participants to complete a survey to rate how comfortable and tolerable it is to use the armband device. This will be completed on discharge from hospital.
Secondary outcome [7] 310624 0
Functional Performance Inventory - Short Form
Timepoint [7] 310624 0
Day of discharge from hospital and 6 weeks post the day of admission

Eligibility
Key inclusion criteria
- Sex: Both female and male
- Age range: 40+ years
- Weight: No weight limit
- Height: No height limit
- Disease status: Hospitalized for an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
- Current or ex-smoker.
- Willingness to give written or oral informed consent. (written as appropriate if participant is too unwell to give a written consent but able to provide a oral informed consent) and willingness to participate to and comply with the study.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Cognitive Impairment (MMSE<24) MMSE
-Unstable cardiac or neurological disease
-Inability to consent or understand English
-Participants lives out of area participants (i.e. those who live in rural areas) from the study as this group of participants will find it too difficult to return for final testing (i.e. the 6 weeks post admission date) at the Prince of Wales Hospital.
-participants who walks with a frame dur to the armband device is unable to detect step counts on this population

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/04/2011
Actual
19/04/2011
Date of last participant enrolment
Anticipated
Actual
14/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264766 0
University
Name [1] 264766 0
The University of Sydney
Country [1] 264766 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Physiotherapy Department,
The Prince of Wales Hospital,
Level 1, high street, Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 263884 0
Hospital
Name [1] 263884 0
Prince of Wales Hospital
Address [1] 263884 0
Respiratory Medicine, Prince of Wales Hospital, Randwick, NSW, 2031
Country [1] 263884 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266744 0
South Eastern Sydney and Illawara Health Serivce
Ethics committee address [1] 266744 0
Ethics committee country [1] 266744 0
Australia
Date submitted for ethics approval [1] 266744 0
25/11/2010
Approval date [1] 266744 0
11/03/2011
Ethics approval number [1] 266744 0
1/10/0210

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32402 0
Ms Ling Ling Tsai
Address 32402 0
Prince of Wales Hospital, Physiotherapy Department, Level 1, High street, Randwick, NSW 2031
Country 32402 0
Australia
Phone 32402 0
+61 410586987
Fax 32402 0
Email 32402 0
[email protected]
Contact person for public queries
Name 15649 0
Ling Ling Tsai
Address 15649 0
Prince of Wales Hospital,
Physiotherapy Department,
Level 1, High street, Randwick,
NSW 2031
Country 15649 0
Australia
Phone 15649 0
+61 410586987
Fax 15649 0
Email 15649 0
[email protected]
Contact person for scientific queries
Name 6577 0
Ling Ling Tsai
Address 6577 0
Prince of Wales Hospital,
Physiotherapy Department,
Level 1, High street, Randwick,
NSW 2031
Country 6577 0
Australia
Phone 6577 0
+61 410586987
Fax 6577 0
Email 6577 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
SourceTitleYear of PublicationDOI
EmbasePhysical activity levels improve following discharge in people admitted to hospital with an acute exacerbation of chronic obstructive pulmonary disease.2016https://dx.doi.org/10.1177/1479972315603715
N.B. These documents automatically identified may not have been verified by the study sponsor.