Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Physical Activity
  • Postoperative Complications
  • Surgery- Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Masking Description: DoublePrimary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) ...

Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness over a short period need to be investigated. This project will examine the influence of exercise prehabilitation on physiological outcomes and postoperative recovery, evaluation of health economics, the impact of the programme on hospital costs. This study will take the form of a randomised controlled trial aimed primarily at improving pre-operative fitness with high intensity interval training (HIIT). HIIT prescribes aerobic exercise which alternates between periods of high intensity training and active recovery. This form of exercise training stimulates greater improvements in cardiopulmonary fitness over short periods compared to continuous aerobic training and therefore may be ideally suited to exercise prehabilitation. The primary outcome, cardiopulmonary fitness, will be measured by cardiopulmonary exercise testing and explored further using a suite of pulmonary and physical performance measures. Secondary outcomes will examine the impact of individually prescribed HIIT on postoperative outcome, postoperative physical recovery, restoration of pre-treatment fitness levels and both acute and sub-acute hospital costs. The investigators anticipate that this mode of exercise prehabilitation will attenuate postoperative risk and improve postoperative recovery, thus improving patient quality of life and having considerable economic benefits for the healthcare system.

Tracking Information

NCT #
NCT03978325
Collaborators
  • Health Research Board, Ireland
  • Medical Research Charities Group Ireland
Investigators
Principal Investigator: Juliette Hussey, PhD University of Dublin, Trinity College