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Trial registered on ANZCTR


Registration number
ACTRN12614001187639
Ethics application status
Approved
Date submitted
9/09/2014
Date registered
12/11/2014
Date last updated
24/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Multimorbidity rehabilitation in chronic disease: general rehabilitation compared to usual care
Scientific title
What is the effect of a generic outpatient exercise rehabilitation program compared to usual care on functional exercise tolerance in people with multimorbidity: a pilot parallel randomized controlled trial.
Secondary ID [1] 285305 0
Nil
Universal Trial Number (UTN)
U1111-1160-6643
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multimorbidity 292999 0
Chronic disease 293000 0
Chronic obstructive pulmonary disease 293001 0
Bronchiectasis 293002 0
Chronic asthma 293003 0
Chronic heart failure 293004 0
Coronary artery disease 293005 0
Ischemic heart disease 293006 0
Diabetes 293007 0
Depression 293008 0
Osteoarthritis 293009 0
Chronic kidney disease 293010 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293280 293280 0 0
Physiotherapy
Respiratory 293281 293281 0 0
Chronic obstructive pulmonary disease
Cardiovascular 293282 293282 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multimorbidity (generic) rehabilitation
Will be administered in small group sessions supervised by a physiotherapist and a nurse, twice-weekly for 8 weeks, including aerobic exercise (walking and cycling for 15 minutes each) and resistance exercise (upper and lower limbs). Session duration will be 75 minutes twice weekly, with an education session duration of one hour once weekly. Education sessions will be delivered by health professionals including a physiotherapist, nursing, dietician to the class group of patients. Education topics will include general information on chronic disease and multimorbidity, risk factor management, exercise, dietary management, diabetes education, pharmacological and psychological support.

Initial aerobic exercise prescription will be calculated at 80% of peak walking speed or distance (ALF & APA, 2009 and National Heart Foundation of Australia, 2011) and stationary cycling intensity will be calculated at 60-80% of maximum work rate estimated from the 6-minute walk test (Hill et al 2008). Exercise prescription will be progressed using a rating of perceived exertion (RPE) Borg scale (6-20) and dyspnoea modified Borg scale, aiming for a RPE score of 12-14 and a dyspnoea score of 3-4. The aerobic component will include intermittent, incline, treadmill training in patients with peripheral vascular disease as their primary presenting complaint or who have a significant contribution from this as part of their presentation (Gardner et al, 1995).

Initial resistance exercise load will correspond to 10-12 RM (repetition maximum). A weight that can be lifted correctly and comfortably at least 10 times, but not more than 12 times (Kraemer et al 2004).
Resistance exercise will be progressed using a rating of perceived exertion (RPE) Borg scale (6-20) aiming for a RPE score of 12-14.
Intervention code [1] 290214 0
Rehabilitation
Comparator / control treatment
Usual medical care defined as medications, GP and specialist attendance, adherence to recommended activities by medical treating teams, excluding structured exercise rehabilitation. Details of usual medical care will be recorded.

Patients will be telephoned twice a week to offer general support about their condition (excluding discussion of exercise or activity), to control for the effects of attention.
Control group
Active

Outcomes
Primary outcome [1] 293120 0
Change in functional exercise capacity (as measured by the 6-minute walk test)
Timepoint [1] 293120 0
Completion of rehabilitation program or usual care (eight weeks following commencement)
Secondary outcome [1] 310404 0
Functional activities of daily living (as measured by the Katz ADL index)
Timepoint [1] 310404 0
Completion of rehabilitation or usual care (8 weeks following recruitment)
Secondary outcome [2] 310405 0
Health-related quality of life (as measured by the SF-36, AQoL-4D, EQ-5D-5L)
Timepoint [2] 310405 0
Completion of rehabilitation or usual care (8 weeks following recruitment)
Secondary outcome [3] 310406 0
Participant daily diary including hospital admissions and medical consultations)
Timepoint [3] 310406 0
Completion of rehabilitation or usual care (8 weeks following recruitment)
Secondary outcome [4] 310407 0
Resource utilization (measured from the diary completed by participants, calculating costs of GP appointments, hospitalisations)
Timepoint [4] 310407 0
Completion of rehabilitation or usual care (8 weeks following recruitment)
Secondary outcome [5] 310408 0
Catastrophic health events (calculated from diary); for example myocardial infarction, stroke, diabetic coma.
Timepoint [5] 310408 0
Completion of rehabilitation or usual care (8 weeks following recruitment)

Eligibility
Key inclusion criteria
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):
Chronic obstructive pulmonary disease
- Bronchiectasis
- Chronic asthma
- Chronic heart failure
- Coronary artery disease
- Ischaemic heart disease
- Diabetes
- Chronic kidney disease
- Depression or anxiety
- New diagnosis of cancer in past 5 years
- Stroke and transient ischaemic attack
- Peripheral vascular disease
- Parkinson's disease
- Multiple sclerosis
- Chronic liver disease
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/microL; 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. 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
Not Applicable
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
Completed
Date of first participant enrolment
Anticipated
17/11/2014
Actual
22/12/2014
Date of last participant enrolment
Anticipated
30/01/2015
Actual
5/05/2015
Date of last data collection
Anticipated
Actual
10/07/2015
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2969 0
Western Hospital - Footscray
Recruitment hospital [2] 2970 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 2971 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 8680 0
3011 - Footscray
Recruitment postcode(s) [2] 8681 0
3021 - St Albans
Recruitment postcode(s) [3] 8682 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 289924 0
Government body
Name [1] 289924 0
Department of Health (Victoria)
Country [1] 289924 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] 288615 0
Hospital
Name [1] 288615 0
Western Health
Address [1] 288615 0
176 Furlong Road
St Albans
VIC 3021
Country [1] 288615 0
Australia
Secondary sponsor category [2] 288616 0
Individual
Name [2] 288616 0
Kathryn Barker
Address [2] 288616 0
Sunshine Hospital
176 Furlong Road
St Albans
VIC 3021
Country [2] 288616 0
Australia
Other collaborator category [1] 278150 0
Individual
Name [1] 278150 0
A/Prof Anne Holland
Address [1] 278150 0
La Trobe University / Alfred Health
Level 4, The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country [1] 278150 0
Australia
Other collaborator category [2] 278151 0
Individual
Name [2] 278151 0
Dr Annemarie Lee
Address [2] 278151 0
Respiratory Medicine
West Park Healthcare Centre
82 Buttonwood Avenue
Toronto, M6M 2J5
Ontario, Canada
Country [2] 278151 0
Canada
Other collaborator category [3] 278152 0
Individual
Name [3] 278152 0
A/Prof Terry Haines
Address [3] 278152 0
Allied Health Research Unit
Kingston Centre
400 Warrigal Road
Cheltenham VIC 3192
Country [3] 278152 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291641 0
Melbourne Health
Ethics committee address [1] 291641 0
Grattan Street
Parkville 3052 VIC
Ethics committee country [1] 291641 0
Australia
Date submitted for ethics approval [1] 291641 0
Approval date [1] 291641 0
25/07/2014
Ethics approval number [1] 291641 0
2014.029

Summary
Brief summary
People with chronic disease only have access to structured exercise rehabilitation programs in tertiary health
services if they have a diagnosis of chronic respiratory disease, chronic heart failure or have suffered a heart
attack/undergone heart surgery.

Current exercise rehabilitation programs address these conditions in a single disease assessment and management strategy, although the frequency of people with multiple chronic conditions (or multimorbidity) in Australia is increasing. Research suggests that other people with chronic diseases (such as cancer, diabetes, chronic kidney disease) also benefit from exercise training however these people are unable to access structured exercise rehabilitation currently as funding to run these services is lacking.

The aim of this project is to pilot the implementation of a generic rehabilitation program for people with chronic disease in a parallel randomised controlled trial. This trial will randomise people with multimorbidity to receiving a generic chronic disease rehabilitation program or usual care.

The aim of this pilot trial (one of a pair) is to test the feasibility of implementing a generic chronic disease rehabilitation program (multimorbidity rehabilitation) and to measure effect sizes that will be used to power subsequent large randomised controlled trials to answer the questions of efficacy and cost-effectiveness.
Trial website
Trial related presentations / publications
Preliminary findings presented at:
- National Australian Physiotherapy Conference, Gold Coast, October 2015
Barker K, Ritchie K, Lee AM, Holland AE, Haines TP, Turczyniak M, Thomas L, Boote C, Saliba J, Lowe S, Pazsa F, Skinner EH. Generalized outpatient rehabilitation program compared to usual care on functional exercise tolerance in people with multimorbidity: a pilot randomized controlled trial.

- Western Health Research Week, Melbourne, November 2015
Barker K, Ritchie K, Lee AM, Holland AE, Haines TP, Turczyniak M, Thomas L, Boote C, Saliba J, Lowe S, Pazsa F, Skinner EH. Generalized compared to disease-specific outpatient rehabilitation, or usual medical care, on functional exercise tolerance in people with multimorbidity: two pilot randomized controlled trials.
Public notes

Contacts
Principal investigator
Name 51306 0
Dr Elizabeth Skinner
Address 51306 0
Western Centre for Health Research and Education
176 Furlong Road
St Albans
VIC 3021
Country 51306 0
Australia
Phone 51306 0
+61 419 101708
Fax 51306 0
Email 51306 0
[email protected]
Contact person for public queries
Name 51307 0
Elizabeth Skinner
Address 51307 0
Western Centre for Health Research and Education
176 Furlong Road
St Albans
VIC 3021
Country 51307 0
Australia
Phone 51307 0
+61 419 101708
Fax 51307 0
Email 51307 0
[email protected]
Contact person for scientific queries
Name 51308 0
Elizabeth Skinner
Address 51308 0
Western Centre for Health Research and Education
176 Furlong Road
St Albans
VIC 3021
Country 51308 0
Australia
Phone 51308 0
+61 419 101708
Fax 51308 0
Email 51308 0
[email protected]

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