Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001100088
Ethics application status
Approved
Date submitted
10/12/2010
Date registered
16/12/2010
Date last updated
16/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Inpatient mobilisation and its outcomes on patients admitted with acute heart failure
Scientific title
Inpatient mobilisation and its outcomes on patients admitted with acute heart failure
Secondary ID [1] 253273 0
HREC/10/QPCH/99
Universal Trial Number (UTN)
U1111-1118-4339
Trial acronym
MOBILE-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute heart failure 258768 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258913 258913 0 0
Physiotherapy
Cardiovascular 258914 258914 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twice daily, progressive mobilisation of up to 30 minutes each day, performed one on one with a physiotherpist until discharge from hospital, unless contraindicated. All participants (including the intervention and control groups) will receive standard care.

Initial assessment comprises a timed 10m walk test, and the Human actvity Profile questionnaire.
Intervention code [1] 257706 0
Rehabilitation
Comparator / control treatment
Standard care comprises individual education about physical activity for heart failure, with in-hospital and home exercise. All patients will receive standard care.
Control group
Active

Outcomes
Primary outcome [1] 259774 0
Safety and feasibility: measured by the number of adverse events recorded (episodes of haemodynamic instability), the number of times the participant did not meet the safety criteria so intervention could not be performed; and the number of heart failure patients included in the study compared to the number admitted, time taken and compliance of physio to perform the intervention
Timepoint [1] 259774 0
Daily during the intervention
Primary outcome [2] 259775 0
Walking capacity measured by the best distance covered in two six minute walk tests conducted consecutively with 15 minutes rest
Timepoint [2] 259775 0
Day of discharge
Primary outcome [3] 259776 0
Return to activities of daily living measured by the 'Human Activity Profile' questionnaire
Timepoint [3] 259776 0
At initial assesment, day of discharge and within 2-4 weeks of discharge
Secondary outcome [1] 268547 0
Activity levels both immediately prior to and following discharge from hospital using sensewear armbands and Duke Activity Status Index (DASI) questionnaire
Timepoint [1] 268547 0
The week prior to and the week following discharge from hospital

The DASI will be measured at initial assesment, on the day of discharge and at 2-4 weeks following discharge from hospital
Secondary outcome [2] 268548 0
Walking speed measured by the 10m walk test
Timepoint [2] 268548 0
At initial assessment and discharge
Secondary outcome [3] 268549 0
Quality of life measured by the Minnesota Living with Heart Failure questionnaire
Timepoint [3] 268549 0
Day of discharge and within 2-4 weeks of discharge
Secondary outcome [4] 268550 0
Hospital length of stay measured by the number of days spent in hospital from admission to discharge taken from medical records.
Timepoint [4] 268550 0
Measured from admission to discharge from hospital
Secondary outcome [5] 268551 0
Readmission to hospital measured over a 12 month period following the intervention as taken from medical records
Timepoint [5] 268551 0
Monitored over a 12 month period

Eligibility
Key inclusion criteria
Patients admitted to hospital with
1. A primary diagnosis of ‘acute heart failure’, ‘heart failure’ or ‘exacerbation of heart failure’ or 'congestive cardiac failure' as diagnosed and documented by their treating physician.
2. Have been started on medical therapy for heart failure
3. Satisfy safety criteria (detailed below)
4. Provide signed written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
New York Heart Association Classification: IV (shortness of breath at rest)
Terminally ill
Poor cognition or reduced ability for self care as deemed by treating medical team
Orthopaedic or other limitations that prevent mobility
Awaiting therapeutic cardiovascular procedure or hospitalisation for surgery
Presence of heart failure secondary to significant uncorrected primary valvular disease (except for mitral regurgitation secondary to LV dysfunction), new onset atrial fibrillation, anaemia
Obstructive and restrictive cardiomyopathies (diastolic heart failure)
Pacemakers which do not permit adequate heart rate response to exercise
Inability or refusal to sign informed consent

Safety criteria
Participants will not undergo mobilisation if they:
Are haemodynamically unstable
Show signs of recent heart attack including such as new/recurrent chest pain in the past 8 hours, rising troponin levels
Show new signs of uncompensated heart failure (such as dyspnoea at rest)
Show signs of heart electrical conduction problems (e.g. 3rd-degree AV block)
Have uncontrolled irregular heart rhythms (e.g. recurrent ventricular tachycardia or ventricular fibrillation, fast heart rate >110 beats per minute)
Have a resting systolic blood pressure >200mmHg or resting diastolic blood pressure of >110mmHg
Have a resting systolic blood pressure of <90mmHg patient will be reviewed by the medical team prior to mobilisation
Have poorly controlled symptomatic postural or low blood pressure (drop of >20mmHg with symptoms)
Resting oxygen saturation: <92%
Clinical judgement by the exercise specialist that patient clinical presentation is such that it would preclude safe mobility

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)
Initial contact will be made with potential participants on the ward. Participants will be screened against the inclusion and exclusion criteria. All participants will have medical clearance to be involved in this study. An information sheet will be provided to participants, and an opportunity to have all their questions answered by a member of the investigative team. Informed consent will be signed. Following the initial blinded assessment, patient allocation to the intervention and usual care groups will be undertaken via randomisation using a computer generated program by a person not involved in the recruitment and assessment of the participants. Participant allocation will be concealed using closed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following the initial blinded assessment, patient allocation to the intervention and usual care groups will be undertaken via randomisation using a computer generated program by a person not involved in the recruitment and assessment of the participants. To ensure approximate equal numbers in each group, a permuted block randomisation will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
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
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258193 0
Self funded/Unfunded
Name [1] 258193 0
Country [1] 258193 0
Primary sponsor type
Individual
Name
Lisa Moore
Address
c/o Physiotherapy Department
The Prince Charles Hospital
Rode Rd
Chermside Qld 4032
Country
Australia
Secondary sponsor category [1] 257348 0
Individual
Name [1] 257348 0
Amy Bullen
Address [1] 257348 0
c/o Physiotherapy Department
The Prince Charles Hospital
Rode Rd
Chermside Qld 4032
Country [1] 257348 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260163 0
The Prince Charles Hospital, Metro North Health Service District
Ethics committee address [1] 260163 0
Human Research Ethics Committee
The Prince Charles Hospital
Rode Rd
Chermside Qld 4032
Ethics committee country [1] 260163 0
Australia
Date submitted for ethics approval [1] 260163 0
15/07/2010
Approval date [1] 260163 0
04/08/2010
Ethics approval number [1] 260163 0
HREC/10/QPCH/99

Summary
Brief summary
Each participant will receive physiotherapy treatment involving one-on-one education about physical activity for heart failure, including guidelines for walking and exercise while an inpatient at The Prince Charles Hospital. A walking and exercise program for home will also be provided before discharge.

In addition, those in the walking group will receive twice daily walking supervised by a physiotherapist. Treatment will take up to 40 minutes each day to complete and will be carried out each day until discharge.

All participants will undergo an assessment prior to discharge involving a walking test to measure walking capacity in 6 minutes and activity levels. Soon after discharge activity levels will again be monitored and all participants will receive surveys looking at quality of life and return to everyday activity in the community.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 31988 0
Address 31988 0
Country 31988 0
Phone 31988 0
Fax 31988 0
Email 31988 0
Contact person for public queries
Name 15235 0
Lisa Moore
Address 15235 0
c/o Physiotherapy Department
The Prince Charles Hospital
Rode Rd
Chermside Qld 4032
Country 15235 0
Australia
Phone 15235 0
+61 7 3139 5308
Fax 15235 0
Email 15235 0
[email protected]
Contact person for scientific queries
Name 6163 0
Lisa Moore
Address 6163 0
c/o Physiotherapy Department
The Prince Charles Hospital
Rode Rd
Chermside Qld 4032
Country 6163 0
Australia
Phone 6163 0
+61 7 3139 5308
Fax 6163 0
Email 6163 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.