Preoperative Exercise for Patients Undergoing Complex Cancer Surgery

NCT03978325 | Unknown

• 1 other identifier: Pre-HIIT
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment for people with cancer of the lung or the oesophagus (food-pipe) often involves surgery. This surgery is complex and there is a high risk that patients will develop severe complications afterwards, leading to a longer hospital stay and higher hospital costs, and impacting greatly on recovery and quality of life. If patients' lungs and heart can be optimised before surgery, then recovery may be improved. While fitness can be improved by exercise, the lead-in time to surgery following a cancer diagnosis is often very short, and research is needed to examine what types of exercise might be most effective at increasing fitness over a short period. This project will investigate if high intensity interval training (HIIT) can increase fitness levels in people scheduled for surgery for cancer of the oesophagus or the lungs. HIIT alternates between periods of high intensity exercise, cycling on a stationary bike, followed by a period of more relaxed exercise. This approach is known to improve fitness but has not previously been investigated in patients awaiting complex cancer surgery. Groups will be compared for changes in pre-surgery fitness levels, any complications they may experience after surgery, general physical recovery after surgery and the cost of care after surgery. The investigators anticipate that patients who undergo HIIT before surgery will have less complications and better recovery after surgery, a significantly improved quality of life, and lower costs of care.

Conditions

Postoperative Complications; Physical Activity; Surgery--Complications

Keywords

Prehabilitation; Exercise; Surgery

Outcome Measures

Primary Outcomes (1)

• Change in Cardiorespiratory Fitness

  Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)

  At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)

Secondary Outcomes (14)

• Clavien-Dindo Scale

  At hospital discharge (approximately 7-14 days postoperatively)

• Change in the Post-Operative Morbidity Score (POMS)

  On postoperative day 5, postoperative day 7 and at hospital discharge (approximately 7-14 days postoperatively)

• The Comprehensive Classification Index (CCI)

  At hospital discharge (approximately 7-14 days postoperatively)

• Change in Pulmonary function

  At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)

• Change in Maximum Inspiratory pressure

  At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)

Study Arms (2)

Control

ACTIVE COMPARATOR

This arm will complete a standard prehabilitation intervention.

Other: Control

HIIT Intervention

EXPERIMENTAL

This group will complete a pre-operative high intensity interval training programme.

Other: Exercise - HIIT Intervention

Interventions

Control OTHER

The control group will receive standard pre-operative care. This involves standard pre-operative advice and a moderate intensity preoperative exercise programme.

Control

Exercise - HIIT Intervention OTHER

The HIIT intervention will take the form of a supervised programme, completed for at least two weeks, up to 5 days per week preoperatively. The HIIT intervention will be performed on a cycle ergometer. Exercise sessions will be individually supervised and scheduled at a time of convenience for each participant. Each exercise session will last 40 minutes and will include warm-up, exercise training and cool-down components. Lactate threshold, measured during the baseline CPT, will be used to determine the exercise intensity. The training protocol will prescribe 15 second intervals of exercise and passive recovery. The highest resistance reached during the baseline CPET (measured in watts) will be recorded as the peak power output (PPO). During training, participants will undergo a 5-minute warm-up at 50% PPO, followed by up to 30 minutes of HIIT with intervals of 15 seconds at 100% PPO with 15 second recovery periods at 0 watts.

HIIT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled for either oesophagectomy (2-stage or 3-stage) or major lung resection for the management of primary oesophageal or lung cancer.
• Date of surgery ≥ 2 weeks from baseline assessment
• Ability to provide written informed consent
• Absence of significant co-morbidities, including metastatic disease, which may adversely impact postoperative outcome
• Successful completion of a medically supervised cardiopulmonary exercise test
• Patients with oesophageal cancer scheduled for multimodal therapy including preoperative chemo(radio)therapy and oesophagectomy will be recruited and tested prior to treatment commencement.

You may not qualify if:

• The American Thoracic Society/American College of Chest Physicians (ATS/ACCP) absolute contraindications for exercise testing will be applied.
• Patients undergoing video assisted lobectomy for early lung cancer will be excluded.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Health Research Board, Ireland: collaborator
• Irish Cancer Society: collaborator

Study Sites (1)

University of Dublin, Trinity College

Dublin, Ireland

RECRUITING

Related Publications (1)

• Sheill G, Guinan E, O'Neill L, Normand C, Doyle SL, Moore S, Newell J, McDermott G, Ryan R, Reynolds JV, Hussey J. Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial. BMC Cancer. 2020 Apr 15;20(1):321. doi: 10.1186/s12885-020-06795-4.

  PMID: 32293334 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Juliette Hussey, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gráinne Sheill, PhD

CONTACT

01-8964809; sheillg@tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiotherapy

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: June 7, 2019
• Study Start: July 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

IE (1)