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Preoperative HIIT in Elderly Cancer Patients (eHIITCa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671617
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Tracking Information
First Submitted Date  ICMJE January 18, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date September 14, 2018
Study Start Date  ICMJE August 2016
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative HIIT in Elderly Cancer Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cancer
Intervention  ICMJE Other: High intensity interval training (HIIT)
Preoperative HIIT protocol.
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2018)
40
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2016)
48
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671617
Other Study ID Numbers  ICMJE eHIITCa
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual patient data will be made available.
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Williams, MBChB FRCA PhD Nottingham University
PRS Account University of Nottingham
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP