Preoperative HIIT in Elderly Cancer Patients

Cancer Clinical Trial

— eHIITCa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671617
• Other study ID #: eHIITCa
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• High intensity interval training (HIIT)
Preoperative HIIT protocol.

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby	Derbyshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2AT (VO2 at anaerobic threshold)	Change in anaerobic threshold seen during maximal exercise test (pre and post intervention).	Baseline and 4 weeks
Secondary	VO2peak	Change in peak volume of oxygen consumption during maximal exercise test (pre and post intervention).	Baseline and 4 weeks
Secondary	Subjective acceptability of HIIT preoperatively (via questionnaire)	Assessment of whether our HIIT protocol is acceptable to patients in this age group.	After 4 weeks of HIIT.
Secondary	Muscle protein synthesis rate changes with HIIT.	Assessment of the effect HIIT has on rate of muscle protein synthesis in this group.	Baseline and 4 weeks.