Preoperative HIIT in Elderly Cancer Patients

NCT02671617 | Completed

• 1 other identifier: eHIITCa
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Abdominal Cavity; Aged

Outcome Measures

Primary Outcomes (1)

• VO2AT (VO2 at anaerobic threshold)

  Change in anaerobic threshold seen during maximal exercise test (pre and post intervention).

  Baseline and 4 weeks

Secondary Outcomes (3)

• VO2peak

  Baseline and 4 weeks

• Subjective acceptability of HIIT preoperatively (via questionnaire)

  After 4 weeks of HIIT.

• Muscle protein synthesis rate changes with HIIT.

  Baseline and 4 weeks.

Study Arms (2)

Control

NO INTERVENTION

Control: This group of patients will receive 'current best practice' as per UK NHS recommendations for their specific cancer management prior to surgery.

High intensity interval training

EXPERIMENTAL

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)

Interventions

High intensity interval training (HIIT) OTHER

Preoperative HIIT protocol.

High intensity interval training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John Williams, MBChB FRCA PhD

  Nottingham University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 2, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)