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Does respiratory muscle and general exercise training before open heart surgery improve outcomes in frail older adults

Effects of pre-operative inspiratory muscle and physical exercise training on cardiac surgical outcomes in frail elders

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000435482
Acronym
PrIMEd study (PRe-operative Inspiratory Muscle training and Exercise)
Enrollment
60
Registered
2016-04-05
Start date
2016-05-02
Completion date
2016-12-23
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Alison Mahoney
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
75 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026