eHIITCa: Preoperative HIIT in Elderly Cancer Patients

Sponsor
University of Nottingham (Other)
Overall Status
Completed
CT.gov ID
NCT02671617
Collaborator
(none)
40
1
2
24
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High intensity interval training (HIIT)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Randomised Control Trial to Assess Efficacy of Preoperative High Intensity Interval Training in Elderly Patients Scheduled for Oncological Abdominal Surgery
Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. VO2AT (VO2 at anaerobic threshold) [Baseline and 4 weeks]

    Change in anaerobic threshold seen during maximal exercise test (pre and post intervention).

Secondary Outcome Measures

  1. VO2peak [Baseline and 4 weeks]

    Change in peak volume of oxygen consumption during maximal exercise test (pre and post intervention).

  2. Subjective acceptability of HIIT preoperatively (via questionnaire) [After 4 weeks of HIIT.]

    Assessment of whether our HIIT protocol is acceptable to patients in this age group.

  3. Muscle protein synthesis rate changes with HIIT. [Baseline and 4 weeks.]

    Assessment of the effect HIIT has on rate of muscle protein synthesis in this group.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Derby Hospital Derby Derbyshire United Kingdom DE22 3NE

Sponsors and Collaborators

  • University of Nottingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT02671617
Other Study ID Numbers:
  • eHIITCa
First Posted:
Feb 2, 2016
Last Update Posted:
Sep 14, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Nottingham

Study Results

No Results Posted as of Sep 14, 2018