Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000435482
Ethics application status
Approved
Date submitted
28/01/2016
Date registered
5/04/2016
Date last updated
5/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does respiratory muscle and general exercise training before open heart surgery improve outcomes in frail older adults
Scientific title
Effects of pre-operative inspiratory muscle and physical exercise training on cardiac surgical outcomes in frail elders
Secondary ID [1] 288379 0
none
Universal Trial Number (UTN)
Trial acronym
PrIMEd study (PRe-operative Inspiratory Muscle training and Exercise)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open Heart Surgery 297379 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297565 297565 0 0
Physiotherapy
Cardiovascular 298387 298387 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The specific intervention is as follows:
The intervention group are given a pre-operative home exercise program of inspiratory muscle training (IMT), upper limb (UL) exercises, lower limb (LL) exercises and a walking program, This is taught by an associate research physiotherapist. The participants are provided with an IMT device to take home for the purposes of inspiratory muscle training (Phillips Respironics, TGA approved and currently in use at The Prince Charles Hospital) and are taught in its use and safe progressions at home. The IMT prescription is to perform training in sets of 10, and repeat for a minimum of 6 -8 sets, over a 20 minute period, every day until admission to hospital for surgery. The resistance set is initially 30% of MIP (PiMax) and is adjusted to achieve a Borg scale rating of 14-16 on the 6-20 scale. Participants are educated in adjustment of the IMT device to maintain this level of exertion throughout their training.
Participants in the intervention group are prescribed an individualised physical home-based exercise program of UL and LL exercise and walking to be done every day. This is light strengthening with weights for the upper limbs (light dumbells 1 - 3 kg), and/or body weight resisted exercise for the lower limbs (1/4 squats, sit to stand, toe raises, marching, sideleg lifts, lunges, step ups etc), done at a level of 11-13 on the 6-20 Borg scale . Exercises and repetitions prescribed will slightly vary according to the participant's physical capacity, as judged by patient history and the Timed Up and Go Test (TUGT), It is likely the participant will perform 2-3 reps of 10 sets of each exercise prescribed, taking approximately 15-20 minutes per day. The daily walking program is prescribed according to the participants pre-operative walking ability, and will follow the heart foundation guidelines of building up to 30 minutes of exercise on most/all days of the week at a level of exertion of 11-13 on the Borg 6-20 scale. Participants receive a written home exercise program on the IMT and other physical exercises, information on exercise safety and progressions, and receive an exercise diary to encourage compliance.

Participants in the intervention group receive one follow-up phone call at approximately one week by an associate research physiotherapist to encourage compliance and discuss any potential issues.

The intervention group also receive the usual practice pre-operative education that the control group receive. This is one-on-one verbal education of what to expect and what will be done with the physiotherapist post-operatively, and provision of an education booklet. The booklet outlines what the physiotherapist usually teaches pre-operatively, and also contains medical and nursing information. it is currently used for all cardiac surgical patients at The Prince Charles Hospital.

All of the pre-operative exercise intervention as described initially is in addition to this.
Intervention code [1] 293683 0
Rehabilitation
Intervention code [2] 293684 0
Prevention
Comparator / control treatment
The control is as follows:
Participants in the control group all receive usual practice pre-operative education by an associate research physiotherapist at the cardiac surgical pre-operative clinic. This is one-on-one verbal education of what to expect and what will be done with the physiotherapist post-operatively, and provision of an education booklet. The booklet outlines what the physiotherapist usually teaches pre-operatively, and also contains medical and nursing information. it is currently used for all cardiac surgical patients at The Prince Charles Hospital. The pre-operative education session will be 15-20 minutes in duration.

Control group
Active

Outcomes
Primary outcome [1] 297119 0
Post-operative Pulmonary Complications. This will be assessed by the principal research physiotherapist by review of hospital records and monitoring during the participants stay in hospital. Post-operative pulmonary complications will be defined according to The Melbourne Group Scale.
Timepoint [1] 297119 0
It will be measured from immediately post-surgery until hospital discharge.
Primary outcome [2] 297121 0
Hospital length of stay. This will be assessed by the principal research physiotherapist by monitoring of participants during their hospital stay.
Timepoint [2] 297121 0
It will be measured from the participant's hospital admission until hospital discharge.
Secondary outcome [1] 320072 0
TIme to extubation. This will be assessed by the principal research physiotherapist by review of the current hospital intensive care cardiac surgical research database,
Timepoint [1] 320072 0
It will be measured from the end of the surgical procedure until participant extubation post-operatively in the intensive care unit.
Secondary outcome [2] 320073 0
Time to first walk. This will be assessed by the principal research physiotherapist in the course of the participants treatment in the intensive care unit, The principal research physiotherapist will liaise directly with treating physiotherapists in the intensive care unit.
Timepoint [2] 320073 0
This will be measured from the end of the surgical procedure until the participant's first walk. Walk is defined as standing at the bedside and marching on the spot for a least 30 seconds, or walking away from the bedside.
Secondary outcome [3] 320074 0
Intensive care unit length of stay. This will be assessed by the principal research physiotherapist by review of the current hospital intensive care cardiac surgical research database,
Timepoint [3] 320074 0
This will be measured from the participant admission to the intensive care unit, until the participant's discharge to the surgical ward.
Secondary outcome [4] 320075 0
Changes to Maximal Inspiratory Pressure (MIP, PiMax). This is assessed by the principal research physiotherapist with a portable pressure measuring device, as the best of 3 attempts. This reflects the strength of the diaphragm and other inspiratory muscles.
Timepoint [4] 320075 0
This is assessed at 4 timepoints:
*Pre-operatively in the cardiac surgical outpatient clinic
*Pre-operatively, at participant's hospital admission immediately prior to surgery
*Post-operatively, prior to participant's discharge home - approximately day 4-5 post-surgery
*Post-operatively, at 6 week post-surgery cardiac outpatient clinic appointment
Secondary outcome [5] 320076 0
Timed Up and Go Test (TUGT). This is assessed by the principal research physiotherapist as the best of 3 attempts. Equipment required is a stopwatch and a chair. It is the time taken for the participant to rise from a chair, walk 3 metres, turn and return to sit back down in the chair. This test is directly related to balance, strength and mobility and is sensitive to change in a similar manner to the 6 minute walk test.
Timepoint [5] 320076 0
This is assessed at 4 timepoints:
*Pre-operatively in the cardiac surgical outpatient clinic
*Pre-operatively, at participant's hospital admission immediately prior to surgery
*Post-operatively, prior to participant's discharge home - approximately day 4-5 post-surgery
*Post-operatively, at 6 week post-surgery cardiac outpatient clinic appointment
Secondary outcome [6] 320077 0
Cardiac Rehabilitation Compliance. This is assessed by the principal research physiotherapist by questioning the participant during direct interview at 6 weeks post-operatively, and via telephone at 12 weeks post-operatively.
Timepoint [6] 320077 0
This is assessed at 2 timepoints:
6 weeks post-operatively at usual post-operative clinic- date determined by clinic date set by hospital.
12 weeks post-operatively via telephone review - exact date determined by principal research physiotherapist
Secondary outcome [7] 322491 0
Maximal Expiratory Pressure (MEP. PeMax). This is assessed by the principal research physiotherapist with a portable pressure measuring device, as the best of 3 attempts. This reflects the strength of the abdominal muscles and other expiratory muscles.
Timepoint [7] 322491 0
This is assessed at 4 timepoints:
*Pre-operatively in the cardiac surgical outpatient clinic
*Pre-operatively, at participant's hospital admission immediately prior to surgery
*Post-operatively, prior to participant's discharge home - approximately day 4-5 post-surgery
*Post-operatively, at 6 week post-surgical cardiac outpatient clinic appointment
Secondary outcome [8] 322492 0
SF-36 questionairre. This will be assessed by the principal research physiotherapist. The questionairre will be given directly to the participant at the cardiac surgical appointment, and it will be completed at the clinic. It will be assessed again by giving it to the participant in a sealed envelope at the 6 week review, and asking them to complete it and send back at 12 weeks. It assesses the participants health related quality of life.
Timepoint [8] 322492 0
This is assessed at 2 timepoints:
*Pre-operatively in the cardiac surgical outpatient clinic
*12 weeks post-operatively
Secondary outcome [9] 322493 0
Morbidity. This will be assessed by the principal research physiotherapist by medical record review and direct monitoring of the participant during their surgical admission. The principal research physiotherapist will review again at 6 weeks by direct participant interview and medical record review, and telephone and medical record review at 12 weeks. If a participant has not had surgery from 12 weeks post cardiac surgery clinic review (at time of recruitment), the principal research physiotherapist will review the hospital computer system to determine participant status.
Timepoint [9] 322493 0
This is assessed from the time of initial participant recruitment in the cardiac surgical outpatient clinic until 12 weeks post-surgery.
Secondary outcome [10] 322563 0
Mortality. This will be assessed by the principal research physiotherapist by medical record review and direct monitoring of the participant during their surgical admission. If the participant does not attend, or have a booked 6 week post-operative cardiac surgical outpatient clinic appointment, the principal research physiotherapist will review participant status on the hospital computer data system. Participant mortality will also be assessed at the 12 week telephone review timepoint, when the medical record will be reviewed prior to participant contact. If a participant has not had surgery from 12 weeks post cardiac surgery clinic review (at time of recruitment), the principal research physiotherapist will again review the hospital computer system to determine participant status.
Timepoint [10] 322563 0
This is assessed from the time of initial participant recruitment in the cardiac surgical outpatient clinic until 12 weeks post-surgery.

Eligibility
Key inclusion criteria
*Age 75 years or older with clinically diagnosed frailty according to the Clinical Frailty Scale
*Waiting open coronary artery bypass surgery or valvular surgery
*Written informed consent by patient
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Age under 75 years
*Unable to provide informed consent and/or are unable to participate due to cognitive issues or neurological impairment
*Surgery booked earlier than 2 weeks from assessment
*Severe bullous emphysema and / or previous spontaneous pneumothorax
*Severe osteoporosis with high risk of rib fracture with inspiratory pressures
*Patients deemed medically inappropriate by treating medical staff due to
haemodynamic instability, unstable angina or any other reason

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Identical sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated numbers
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2016
Actual
Date of last participant enrolment
Anticipated
23/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5104 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 12581 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 292764 0
Charities/Societies/Foundations
Name [1] 292764 0
The Prince Charles Hospital Research Foundation
Country [1] 292764 0
Australia
Primary sponsor type
Individual
Name
Alison Mahoney
Address
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
Country
Australia
Secondary sponsor category [1] 292070 0
Hospital
Name [1] 292070 0
The Prince Charles Hospital
Address [1] 292070 0
Rode Rd Chermside QLD 4032
Country [1] 292070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294252 0
The Prince Charles Hospital HREC (EC00168)
Ethics committee address [1] 294252 0
Rode Rd Chermside QLD 4032
Ethics committee country [1] 294252 0
Australia
Date submitted for ethics approval [1] 294252 0
13/01/2016
Approval date [1] 294252 0
11/02/2016
Ethics approval number [1] 294252 0
HREC/16/QPCH/12

Summary
Brief summary
The study design is a single blinded longitudinal Randomised Controlled Trial.
The primary outcome measures are the incidence of post-operative pulmonary complications (PPCs) and hospital length of stay (HLOS).
Study participants will be 60 pre-operative high risk frail elderly cardiac surgical patients identified by the principal research physiotherapist and randomised into an intervention and control group. Eligibility to enter the study will be assessed in the cardiac surgical pre-operative clinic, and patient consent obtained. Pre-intervention measures tested in the clinic will be frailty, the timed up and go test (TUGT), the SF-36, and respiratory measures of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Patients in the control group will receive standard physiotherapy pre-operative education from an associate research physiotherapist.
Patients in the intervention group will receive standard physiotherapy education, from an associate research physiotherapist, and in addition receive an IMT device and be taught in its use and safe progressions at home. They will also be prescribed an individualised physical home-based exercise program. They will receive written education on IMT and exercise and an exercise diary, and will receive one follow-up phone call by an associate research physiotherapist to encourage compliance.
On hospital admission (immediately pre-surgery), patients in both groups will be managed by the principal research physiotherapist who is blinded to the pre-operative interventions. All patients will receive standard physiotherapy during their hospital admission as per usual practice. Pre-operative assessment measures of TUGT and MIP/MEP will be done on admission and on day 4-5 (pre-discharge home). Time dependent events (length of intubation time, time to first walk, length of stay in ICU, hospital length of stay),pulmonary complications, morbidity/mortality, and discharge destination will be recorded by the principal research physiotherapist.
All patients will have TUGT and MIP/MEP measures done by the principal research physiotherapist at 6 weeks post discharge at their usual post-operative clinic appointment. At 12 weeks post discharge, another follow-up call will be made by the principal research physiotherapist to assess compliance with exercise, attendance at cardiac rehabilitation, post-discharge complications and confirm discharge destination. The SF-36 will be assessed at this 12 week mark.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62930 0
Mrs Alison Mahoney
Address 62930 0
Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
Country 62930 0
Australia
Phone 62930 0
+61 7 31395306
Fax 62930 0
Email 62930 0
Alison.Mahoney@health.qld.gov.au
Contact person for public queries
Name 62931 0
Mrs Alison Mahoney
Address 62931 0
Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
Country 62931 0
Australia
Phone 62931 0
+61 7 31395306
Fax 62931 0
Email 62931 0
Alison.Mahoney@health.qld.gov.au
Contact person for scientific queries
Name 62932 0
Mrs Alison Mahoney
Address 62932 0
Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
Country 62932 0
Australia
Phone 62932 0
+61 7 31395306
Fax 62932 0
Email 62932 0
Alison.Mahoney@health.qld.gov.au

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No Supporting Document Provided



Results publications and other study-related documents

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