Preoperative HIIT in Elderly Cancer Patients (eHIITCa)

September 12, 2018 updated by: University of Nottingham

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Baseline and 4 weeks
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
Time Frame: Baseline and 4 weeks
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)
Time Frame: After 4 weeks of HIIT.
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.
Time Frame: Baseline and 4 weeks.
Assessment of the effect HIIT has on rate of muscle protein synthesis in this group.
Baseline and 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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