Trial Review

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Trial registered on ANZCTR


Registration number
Ethics application status
Yes
Date submitted
21/08/2014
Date registered
Date last updated

Titles & IDs
Public title
Multimorbidity rehabilitation in chronic disease
Scientific title
What is the effect of a generic compared to a disease-specific outpatient exercise rehabilitation program on functional exercise tolerance in people with multimorbidity: two pilot parallel randomized controlled trials.
Secondary ID [1] 285199 0
Nil
Universal Trial Number (UTN)
U1111-1160-6643
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multimorbidity; chronic disease; chronic obstructive pulmonary disease; bronchiectasis; chronic asthma; chronic heart failure; coronary artery disease; ischemic heart disease; diabetes; depression; osteoarthritis; chronic kidney disease. 292810 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293104 293104 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Disease-specific rehabilitation
Multimorbidity (generic) rehabilitation
Intervention code [1] 290070 0
Rehabilitation
Comparator / control treatment
Usual medical care
Control group
Active

Outcomes
Primary outcome [1] 292972 0
Change in functional exercise capacity (as measured by the 6-minute walk test)
Timepoint [1] 292972 0
Completion of rehabilitation program or usual care (eight weeks following commencement)
Secondary outcome [1] 310041 0
Functional activities of daily living; health-related quality of life; participant daily diary including hospital admissions and medical consultations); resource utilization; catastrophic health events.
Timepoint [1] 310041 0
Completion of rehabilitation or usual care (8 weeks following recruitment)

Eligibility
Key inclusion criteria
Trial 1: Physician diagnosis of a single disease as follows including:
- Chronic obstructive pulmonary disease
- Bronchiectasis
- Chronic asthma
- Chronic heart failure
- Coronary artery disease
- Ischaemic heart disease
- AND at least one other chronic condition for which rehabilitation is indicated (as listed in the target conditions, including diabetes, chronic kidney disease, etc).

Trial 2: Adult patients (aged > 18) will be eligible to be enrolled if they have a physician diagnosis of two or more chronic conditions for which rehabilitation is indicated (as listed in the target conditions).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to walk > 50 metres;
- Severe cognitive impairment, psychiatric or intellectual disability which would limit ability to participate in a class with distant supervision or ability to complete outcome measures (defined as MMSE <= 18 points);
- Pulmonary hypertension with recent history of dizziness or syncope on exertion (must have medical clearance if mean pulmonary artery pressure > 50 mm Hg); or acute pulmonary embolus;
- Interstitial lung disease;
- Unstable cardiovascular disease (e.g. unstable angina, uncontrolled arrhythmia, NYH Class 4 CHF; uncontrolled hypertension, diastolic pressure > 95 mm Hg);
- Absolute contraindications to exercise (e.g. severe orthopaedic/neurological deficit; severe uncontrolled pain; surgical or medical (including active transmissible infectious disease) restrictions to mobilisation/rehabilitation e.g. diabetic foot; severe ischaemic vascular disease; advanced neuropathy/retinopathy) which would compromise the ability to safely exercise;
- People already participating in a structured exercise rehabilitation program from a community or external provider;
- Uncontrolled diabetes;
- Uncontrolled epilepsy or seizures;
- Extensive brain, skeletal or visceral metastases (confirmed cancer diagnosis);
- Life expectancy considered to be less than 12 months;
- Known thrombocytopaenia (<50×109/l) or severe neutropenia (neutropenia defined as absolute neutrophil count < 500/µL; profound neutropenia defined as ANL < 100 neutrophils/mm3, Freifeld et al., 2010);
- Room air desaturation at rest < 85%;
- Abnormal and untreated moderate anaemia (80-109 g/L);
- Pregnant women.

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)
Eligible participants will be randomised in a 1:1 allocation for both pilot trials. Group allocation placed into sealed opaque envelopes by the co-ordinating investigator (ES), who will not be involved in program delivery or outcome measurement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated using computer-generated random numbers by www.randomization.com.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a pilot trial, the sample sizes will be a sample of convenience and the data will be used to power for subsequent large randomised controlled trials. Data analysis will be by intention-to-treat. Planned sub-group analyses will be conducted based on the primary presenting disease (e.g. chronic obstructive pulmonary disease, peripheral vascular disease) to examine any subgroups demonstrating larger response to multimorbidity rehabilitation to investigate whether stratification by primary diagnosis will be required for future studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2014
Actual
Date of last participant enrolment
Anticipated
15/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2902 0
Western Hospital - Footscray
Recruitment hospital [2] 2903 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 2904 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 8628 0
3011 - Footscray
Recruitment postcode(s) [2] 8629 0
3021 - St Albans
Recruitment postcode(s) [3] 8630 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 289815 0
Government body
Name [1] 289815 0
Department of Health (Victoria)
Country [1] 289815 0
Australia
Primary sponsor type
Individual
Name
Dr Elizabeth Skinner
Address
Western Centre for Health Research and Education
176 Furlong Road
St Albans
VIC 3021
Country
Australia
Secondary sponsor category [1] 288507 0
Hospital
Name [1] 288507 0
Western Health
Address [1] 288507 0
176 Furlong Road St Albans VIC 3021
Country [1] 288507 0
Australia
Secondary sponsor category [2] 288614 0
Individual
Name [2] 288614 0
Kathryn Barker
Address [2] 288614 0
Sunshine Hospital 176 Furlong Road St Albans VIC 3021
Country [2] 288614 0
Australia
Other collaborator category [1] 278114 0
Individual
Name [1] 278114 0
A/Prof Anne Holland
Address [1] 278114 0
La Trobe University / Alfred Health Level 4, The Alfred Centre 99 Commercial Rd Melbourne VIC 3004
Country [1] 278114 0
Australia
Other collaborator category [2] 278115 0
Individual
Name [2] 278115 0
Dr Annemarie Lee
Address [2] 278115 0
TBC
Country [2] 278115 0
Canada
Other collaborator category [3] 278116 0
Individual
Name [3] 278116 0
A/Prof Terry Haines
Address [3] 278116 0
Allied Health Research Unit Kingston Centre Cheltenham VIC 3192
Country [3] 278116 0
Australia

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 291547 0
Melbourne Health
Ethics committee address [1] 291547 0
Ethics committee country [1] 291547 0
Australia
Date submitted for ethics approval [1] 291547 0
Approval date [1] 291547 0
25/07/2014
Ethics approval number [1] 291547 0
2014.029

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

Contacts
Principal investigator
Name 50826 0
Dr Elizabeth Skinner
Address 50826 0
Western Centre for Health Research and Education 176 Furlong Road St Albans VIC 3021
Country 50826 0
Australia
Phone 50826 0
+61 419 101708
Fax 50826 0
Email 50826 0
[email protected]
Contact person for public queries
Name 50827 0
Elizabeth Skinner
Address 50827 0
Western Centre for Health Research and Education 176 Furlong Road St Albans VIC 3021
Country 50827 0
Australia
Phone 50827 0
+61 419 101708
Fax 50827 0
Email 50827 0
[email protected]
Contact person for scientific queries
Name 50828 0
Elizabeth Skinner
Address 50828 0
Western Centre for Health Research and Education 176 Furlong Road St Albans VIC 3021
Country 50828 0
Australia
Phone 50828 0
+61 419 101708
Fax 50828 0
Email 50828 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.