Preoperative HIIT in Elderly Cancer Patients (eHIITCa)

A Randomised Control Trial to Assess Efficacy of Preoperative High Intensity Interval Training in Elderly Patients Scheduled for Oncological Abdominal Surgery

This randomized control trial will determine the effect of short term high intensity interval training (HIIT) on physical fitness, in an elderly patient group with active cancer, prior to surgical resection.

Half of the recruited patients will act as a control group and the other half will undergo a HIIT protocol.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: High intensity interval training (HIIT)

Detailed Description

High intensity interval training (HIIT) has been shown to achieve similar and in some studies better improvements in aerobic fitness versus more traditional endurance based exercise over the same time period. HIIT has also been shown to produce these improvements over a shorter timescale than other methods, in the region of 2-6 weeks. One widely reported barrier to exercise is time availability, HIIT training may be a favorable option to increase fitness as the total time spent exercising is significantly less than other methods. HIIT induces improvements in cardiovascular parameters in healthy elderly subjects, investigators aim to investigate whether these improvements can be matched in patients with cancer and further elucidate the mechanisms behind improvements seen with this type of training.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged over 65 years (no upper age limit).
• Histologically proven, radiologically or direct visualisation leading to high clinical suspicion of cancer.
• Sufficient mobility to be able to exercise on a static exercise bike.
• Ability to give informed consent.
• Ability to travel to RDH to complete the HIIT sessions (may also rely upon dependents/relatives to provide transport).

Exclusion Criteria:

• Adjuvant systemic chemotherapy / radiotherapy treatment for this cancer. Participants with a significant past medical history of:
• Myocardial infarction (within last 6 months)
• Unstable Angina
• Heart failure (NYHA class III/IV)
• Uncontrolled Hypertension (BP>160/100)
• Previous stroke/TIA
• Severe respiratory disease inc. known pulmonary hypertension(>25 mmHg), Forced Expiratory Volume in 1 second <1.5l.
• Brittle asthma / exercise induced asthma
• Known cerebral aneurysm.
• Inclusion in a recent (within 3 months) study which included any form of exercise, taking a drug or ionising radiation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control: This group of patients will receive 'current best practice' as per UK NHS recommendations for their specific cancer management prior to surgery.
Experimental: High intensity interval training; Exercise: Participants in this group will attend 3-4 times per week to complete HIIT training during the period from diagnosis to surgery. High intensity interval training (HIIT)	Other: High intensity interval training (HIIT); Preoperative HIIT protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2AT (VO2 at anaerobic threshold)	Change in anaerobic threshold seen during maximal exercise test (pre and post intervention).	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2peak	Change in peak volume of oxygen consumption during maximal exercise test (pre and post intervention).	Baseline and 4 weeks
Subjective acceptability of HIIT preoperatively (via questionnaire)	Assessment of whether our HIIT protocol is acceptable to patients in this age group.	After 4 weeks of HIIT.
Muscle protein synthesis rate changes with HIIT.	Assessment of the effect HIIT has on rate of muscle protein synthesis in this group.	Baseline and 4 weeks.

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: John Williams, MBChB FRCA PhD, Nottingham University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Aged; Abdominal Cavity
• Other Study ID Numbers: eHIITCa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual patient data will be made available.