Preoperative HIIT in Elderly Cancer Patients | NCT02671617

Studies
Preoperative HIIT in Elderly Cancer Patients

NCT02671617

Sponsor

University of Nottingham

Status

Completed

Last Update Posted

Sep 14, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

High intensity interval training (HIIT)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Jul 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Jan 18, 2016

First Submission Date that Met QC Criteria

Jan 28, 2016

First Posted Date

Feb 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2018

Last Update Posted Date

Sep 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
High intensity interval training (HIIT)	Other	Preoperative HIIT protocol.	High intensity interval training

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
VO2peak	Change in peak volume of oxygen consumption during maximal exercise test (pre and post intervention).	Baseline and 4 weeks
Subjective acceptability of HIIT preoperatively (via questionnaire)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Williams, MBChB FRCA PhD	Nottingham University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Derby Hospital		Derby	Derbyshire	DE22 3NE	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual patient data will be made available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D000072696	High-Intensity Interval Training

Ancestor Terms

ID	Term
D064797	Physical Conditioning, Human
D015444	Exercise
D009043	Motor Activity
D009068	Movement

Browse Leaves

Not provided

Browse Branches

Not provided