Preoperative HIIT in Elderly Cancer Patients

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: High intensity interval training (HIIT)

• Registration Number: NCT02671617
• Lead Sponsor: University of Nottingham

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 Timeline

• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-02
• Study Start: 2016-08
• Primary Completion: 2018-07
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity interval training	High intensity interval training (HIIT)	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)

Primary Outcome Measures

Name	Time	Method
VO2AT (VO2 at anaerobic threshold)	Baseline and 4 weeks	Change in anaerobic threshold seen during maximal exercise test (pre and post intervention).

Secondary Outcome Measures

Name	Time	Method
Subjective acceptability of HIIT preoperatively (via questionnaire)	After 4 weeks of HIIT.	Assessment of whether our HIIT protocol is acceptable to patients in this age group.
VO2peak	Baseline and 4 weeks	Change in peak volume of oxygen consumption during maximal exercise test (pre and post intervention).
Muscle protein synthesis rate changes with HIIT.	Baseline and 4 weeks.	Assessment of the effect HIIT has on rate of muscle protein synthesis in this group.

Trial Locations

Locations (1)

Royal Derby Hospital; 🇬🇧 Derby, Derbyshire, United Kingdom