NCT02188342

Brief Summary

The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

July 10, 2014

Last Update Submit

July 26, 2017

Conditions

Preoperative CareColorectal NeoplasmsAgedExercise

Outcome Measures

Primary Outcomes (1)

  • VO2 peak

    Mean difference in VO2 peak following a HIT programme

    After 31 days of HIT

Secondary Outcomes (5)

  • Anaerobic threshold

    After 31 days of HIT

  • Muscle protein synthesis

    After 31 days of HIT

  • Body composition

    After 31 days of HIT

  • Feasibility

    After 31 days of HIT

  • Quality of life

    After 31 days of HIT

Study Arms (1)

HIT exercise training

EXPERIMENTAL
Behavioral: HIT

Interventions

HITBEHAVIORAL

12 HIT exercise sessions in 31 days on a stationary cycle ergometer

HIT exercise training

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed colorectal cancer
  • Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal Cancer Multidisciplinary Team
  • Male and female
  • years of age

You may not qualify if:

  • Uncontrolled hypertension (BP \> 160/100),
  • Angina,
  • Heart failure (class III/IV),
  • Cardiac arrthymias,
  • Right to left cardiac shunt,
  • Recent cardiac event,
  • Previous stroke/TIA,
  • Aneurysm (large vessel or intracranial),
  • Severe respiratory disease including pulmonary hypertension,
  • COPD/asthma with an FEV1 less than 1.5 l,
  • Coagulation disorders,
  • Scarring disorders.
  • Current neoadjuvant chemo/radiotherapy
  • Inability to complete the consent process Involvement in invasive research study in previous 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Colorectal NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Study Officials

  • John Williams, BSc MBChB FRCA PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 11, 2014

Study Start

January 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations

GB(1)