Preoperative HIIT in Elderly Cancer Patients (eHIITCa)

• ClinicalTrials.gov Identifier: NCT02671617
• Recruitment Status: Completed
• First Posted: February 2, 2016
• Last Update Posted: September 14, 2018
• Sponsor: University of Nottingham
• Information provided by (Responsible Party): University of Nottingham

Tracking Information

• First Submitted Date: January 18, 2016
• First Posted Date: February 2, 2016
• Last Update Posted Date: September 14, 2018
• Study Start Date: August 2016
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 28, 2016)

VO2AT (VO2 at anaerobic threshold) [ Time Frame: Baseline and 4 weeks ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 28, 2016)

• VO2peak [ Time Frame: Baseline and 4 weeks ]
  Change in peak volume of oxygen consumption during maximal exercise test (pre and post intervention).
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Preoperative HIIT in Elderly Cancer Patients
• Official Title: A Randomised Control Trial to Assess Efficacy of Preoperative High Intensity Interval Training in Elderly Patients Scheduled for Oncological Abdominal Surgery

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.

• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Cancer

Intervention

Other: High intensity interval training (HIIT)

Preoperative HIIT protocol.

Study Arms

• 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)

  Intervention: Other: High intensity interval training (HIIT)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2018): 40
• Original Estimated Enrollment (submitted: January 28, 2016): 48
• Actual Study Completion Date: August 2018
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02671617
• Other Study ID Numbers: eHIITCa
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No individual patient data will be made available.

• Responsible Party: University of Nottingham
• Study Sponsor: University of Nottingham
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Nottingham
• Verification Date: September 2018