INSPIRE
Research type
Research Study
Full title
Effectiveness and cost-effectiveness of INSPIRatory musclE training (IMT) for reducing postoperative pulmonary complications (PPC): a sham-controlled randomised controlled trial (RCT)
IRAS ID
250345
Contact name
Maria Pufulete
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
After major operations some patients develop complications of the lungs which affect on average one in ten patients. These complications can be serious and may result in long stays in hospital, admission to intensive care and even death, prolonging recovery from surgery and reducing patients’ quality of life.
Inspiratory muscle training (IMT) is a package of breathing exercises designed to improve the strength and endurance of the muscles in the chest that control breathing. All adult patients having operations in the chest or abdomen under general anaesthesia who have a high risk of lung complications will be invited. Participants will be randomly assigned to one of three different types of breathing exercises in the period leading up to surgery.
High resistance IMT: Participants will be taught to use a hand-held device and to adjust the training load twice a day for a minimum of two weeks.
Low resistance IMT: Participants will do the same as the high resistance group but the device will be set to a training load that will not change.
Usual care. Participants will be given an instruction leaflet and advice about the importance of breathing exercises.The main aim of the study is to compare the number of lung complications between the three groups in the first 30 days after surgery and record whether a lung complication develops in hospital whilst patients are recovering or causes hospital admissions after patients are discharged from hospital following their operation.
The study will be conducted in two phases, Phase 1 and Phase 2. If Phase 1 shows that the study can recruit enough participants according to the set progression criteria and that they can perform their exercises as instructed, we will move to Phase 2. The study will be supported by an integrated QuinteT Recruitment Intervention (QRI).
Lay summary of study results: Using the IMT breathing devices before surgery did not reduce the amount of complications (PPCs) that people had after their surgery. People who had an
additional training visit were not any better of than those who didn’t
However, all additional visits had to be performed online in the pandemic, so we cannot say if in-person visits would have been better. INSPIRE was highly acceptable to patients, and a very high percentage of those approached accepted participation. Adjusting the breathing device
manually worked better for our patients, than using an automatic device. This information is useful for future trials.REC name
London - Bloomsbury Research Ethics Committee
REC reference
19/LO/0546
Date of REC Opinion
16 May 2019
REC opinion
Further Information Favourable Opinion