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Trial registered on ANZCTR


Registration number
ACTRN12612000745842
Ethics application status
Approved
Date submitted
10/07/2012
Date registered
13/07/2012
Date last updated
3/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Rehabilitation in Patients Hospitalised with An Acute Exacerbation of Chronic Obstructive Pulmonary Disease.
Scientific title
Evaluation of exercise training versus usual care on exercise capacity, muscle strength and functional performance in patients hospitalised with an acute exacerbation of Chronic Obstructive Pulmonary Disease.
Secondary ID [1] 280836 0
Nil
Universal Trial Number (UTN)
U1111-1132-4282
Trial acronym
AECOPD: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Exacerbation of Chronic Obstructive Pulmonary Disease (requires hospitalisation) 286903 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287219 287219 0 0
Physiotherapy
Respiratory 287232 287232 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients allocated to the treatment group will receive two individual training sessions daily during the five weekdays, in which the morning session will be supervised, and the afternoon session will be unsupervised. The training sessions will comprise of walking and resistance exercises and will be carried out by a trained physiotherapist. The training will commence within 48 hours of admission until the patients are allowed to be discharged from the hospital. We expect each session (supervised or unsupervised) to take no longer than 30 minutes (inclusive of rests).

Resistance training includes sit to stand, half squats and step exercises. Initial prescription will be determined by one set of individualised number of repetition based on the baseline Sit-To-Stand-Test score. The exercise prescription will be increased by one set on every second day of training.

Walking training will be prescribed based on the baseline two-minute walk distance (2MWD) and progressed on every second day of training by increasing the distance walked during each session by 20%.
Intervention code [1] 285250 0
Rehabilitation
Comparator / control treatment
Patients allocated to the control group will receive the usual medical and physiotherapy care given to patients admitted with an acute exacerbation of COPD according to the Malaysian Clinical Practice Guideline (CPG). It is expected that patients will receive usual care each weekday and the duration of the treatment will range between 15 to 30 minutes (depending on their individual needs).

In this guideline, a patient will be discharged if they meet all the criteria for discharge listed. Therefore, patients allocated to the control group will be involved in this study until they are allowed to be discharge from the hospital.

Patients allocated to the control group will receive usual care which includes:

Usual Medical care as described in the Malaysian COPD Clinical Practice Guidelines (CPG).

Usual Physiotherapy care may comprise airway clearance (if required), strategies to minimise dyspnoea (e.g. pursed lip breathing and positioning), and encouragement to mobilise in the ward.
Control group
Active

Outcomes
Primary outcome [1] 287497 0
Functional exercise capacity will be measured using the two-minute walk test (2MWT).
Timepoint [1] 287497 0
Measurement at baseline and prior to discharge.
Primary outcome [2] 287510 0
Peripheral muscle strength will be measured using a force gauge.
Timepoint [2] 287510 0
Measurement at baseline and prior to discharge.
Primary outcome [3] 287511 0
Functional performance will be measured using the Sit-To-Stand-Test (STST)
Timepoint [3] 287511 0
Measurement at baseline and prior to discharge.
Secondary outcome [1] 298289 0
Physical activity will be measured using a StepWatch Activity Monitor (SAM).
Timepoint [1] 298289 0
Measurement during the hospitalisation period
Secondary outcome [2] 298299 0
Functional performance will be measured using the Timed-Up and Go (TUG) test.
Timepoint [2] 298299 0
Measurement at baseline and prior to discharge

Eligibility
Key inclusion criteria
Patients who are admitted with an AECOPD.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) any contraindication to exercise as listed by the American College of Sports Medicine
(ii) hospitalisation within the previous 14 days
(iii) inability to understand or speak English or Malay

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)
Allocation to intervention will be concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation will be used. The randomisation sequence will be stratified according to the hospital from which the patients were recruited (i.e. Hospital Selayang or Institute of Respiratory Medicine) and the patient’s baseline 2MWD.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size calculation:
Assuming a between-group difference of 15% +/- 14% (alpha = 0.05, 1 - beta = 0.8), a sample size of 15 participants per group was needed (30 in total). This number was increased from 30 to 38 to allow for a 20% attrition rate

Data analyses:
Within- and between-group differences were analysed using a two-way repeated measures analysis of variance (two-way RM-ANOVA). Differences were expressed as mean difference (MD) and 95% confidence interval (CI). Analyses were undertaken according to an intention-to-treat basis.

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 4401 0
Malaysia
State/province [1] 4401 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 285618 0
Charities/Societies/Foundations
Name [1] 285618 0
Malaysian Thoracic Society Research Grant
Address [1] 285618 0
Malaysian Thoracic Society
Suite 2-3, Medical Academies of Malaysia,
210 Jalan Tun Razak,
50400 Kuala Lumpur
Country [1] 285618 0
Malaysia
Primary sponsor type
University
Name
School of Physiotherapy and Curtin Health Innovation Research Institute
Address
Curtin University
Kent Street
Perth
Western Australia
6102
Australia
Country
Australia
Secondary sponsor category [1] 284450 0
University
Name [1] 284450 0
Faculty of Medicine, MARA University of Technology
Address [1] 284450 0
Hospital Selayang
Lebuhraya Selayang-Kepong,
68100 Batu Caves, Selangor Darul Ehsan.
Country [1] 284450 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287615 0
Human Research Ethics Committees of Malaysia Ministry of Health
Ethics committee address [1] 287615 0
Jawatankuasa Etika & Penyelidikan Perubatan (Medical Research & Ethics Committee),
Kementerian Kesihatan Malaysia,
INstitut Pengurusan Kesihatan,
Jalan Rumah Sakit, Bangsar.
59000 Kuala Lumpur
Ethics committee country [1] 287615 0
Malaysia
Date submitted for ethics approval [1] 287615 0
16/10/2012
Approval date [1] 287615 0
19/12/2012
Ethics approval number [1] 287615 0
NMRR-12-971-12644
Ethics committee name [2] 295630 0
Human Research Ethics Committees of Universiti Teknologi MARA
Ethics committee address [2] 295630 0
Faculty of Meedicine,
UiTM Sungai Buloh Campus,
Jalan Hospital
47000 Sungai Buloh
Selangor Darul Ehsan
Ethics committee country [2] 295630 0
Malaysia
Date submitted for ethics approval [2] 295630 0
18/02/2013
Approval date [2] 295630 0
09/04/2013
Ethics approval number [2] 295630 0
600-RMI (5/1/6)
Ethics committee name [3] 295631 0
Human Research Ethics Committees of Curtin University
Ethics committee address [3] 295631 0
Curtin University,
Kent street,
Bentley, 6102.
Western Australia,
Australia.
Ethics committee country [3] 295631 0
Australia
Date submitted for ethics approval [3] 295631 0
08/01/2013
Approval date [3] 295631 0
21/01/2013
Ethics approval number [3] 295631 0
HR 13/2013

Summary
Brief summary
The present study aims at investigating the effects of a standardised exercise training program that comprises of walking and resistance exercises on exercise capacity, quadriceps muscle strength and functional performance in patients hospitalised with an AECOPD.

Study hypotheses
In patients with COPD who are hospitalised with an acute exacerbation of their disease, those who are allocated to the treatment group will show a significantly greater improvement in 2MWD, quadriceps muscle force, performance in the STST and TUG, and physical activity compared to the control group.
Trial website
Trial related presentations / publications
Tahirah F, Jenkins S, Othman SK, Ismail R, Ismail T & Hill K. A randomised controlled trial of individualised, progressed early exercise in patients hospitalised with an acute exacerbation of chronic obstructive pulmonary disease. European Respiratory Journal 2015; 46: Supplement 59, PA 743.
Public notes

Contacts
Principal investigator
Name 34425 0
Mrs Fatim Tahirah Mirza
Address 34425 0
PO Box No 9,
Batu 10 Jalan Taiping,
34300 Bagan Serai,
Perak
Country 34425 0
Malaysia
Phone 34425 0
+6057215739
Fax 34425 0
Email 34425 0
fatim_mirza@yahoo.com
Contact person for public queries
Name 17672 0
Mrs Fatim Tahirah Mirza
Address 17672 0
School of Physiotherapy and Curtin Health Innovation Research Institute
Curtin University
Kent Street
Perth
Western Australia
6102
Australia
Country 17672 0
Australia
Phone 17672 0
+61892669443
Fax 17672 0
+61892663699
Email 17672 0
f.mirzamoh.postgrad@curtin.edu.au
Contact person for scientific queries
Name 8600 0
A/Prof A/Prof Sue Jenkins
Address 8600 0
School of Physiotherapy and Curtin Health Innovation Research Institute
Curtin University
Kent Street
Perth
Western Australia
6102
Australia
Country 8600 0
Australia
Phone 8600 0
+61 8 9266 3639
Fax 8600 0
+61 8 9266 3699
Email 8600 0
S.Jenkins@curtin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary