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Completed

NCT Number: NCT02671617

Preoperative HIIT in Elderly Cancer Patients

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training (HIIT)

Other

Preoperative HIIT protocol.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

A Randomised Control Trial to Assess Efficacy of Preoperative High Intensity Interval Training in Elderly Patients Scheduled for Oncological Abdominal Surgery

Acronym: eHIITCa

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2016
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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