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Preoperative HIIT in Elderly Cancer Patients (eHIITCa)

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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

Study Description
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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
Cancer Other: High intensity interval training (HIIT) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : August 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018
Arms and Interventions
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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
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Primary Outcome Measures :
  1. VO2AT (VO2 at anaerobic threshold) [ Time Frame: Baseline and 4 weeks ]
    Change in anaerobic threshold seen during maximal exercise test (pre and post intervention).


Secondary Outcome Measures :
  1. VO2peak [ Time Frame: 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) [ Time Frame: 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. [ Time Frame: Baseline and 4 weeks. ]
    Assessment of the effect HIIT has on rate of muscle protein synthesis in this group.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671617


Locations
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United Kingdom
Royal Derby Hospital
Derby, Derbyshire, United Kingdom, DE22 3NE
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: John Williams, MBChB FRCA PhD Nottingham University
More Information
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02671617    
Other Study ID Numbers: eHIITCa
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual patient data will be made available.
Keywords provided by University of Nottingham:
Abdominal Cavity
Aged