Clinical trial NCT02671617: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Abdominal Cavity
Aged
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: VO2AT (VO2 at anaerobic threshold)
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: VO2peak
timeFrame: Baseline and 4 weeks
measure: Subjective acceptability of HIIT preoperatively (via questionnaire)
timeFrame: After 4 weeks of HIIT.
measure: Muscle protein synthesis rate changes with HIIT.
timeFrame: Baseline and 4 weeks.
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
Study officials:
affiliation: Nottingham University
name: John Williams, MBChB FRCA PhD
role: PRINCIPAL_INVESTIGATOR
References: