NCT02962219

Brief Summary

The purpose of this feasibility study is to determine whether a structured exercise programme prior to oesophagectomy has: acceptable adherence, is safe, and improves physiological measures of physical fitness above standard care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 28, 2016

Last Update Submit

November 8, 2016

Conditions

Postoperative Complications (Cardiopulmonary)Oesophageal Adenocarcinoma

Keywords

oesophagectomy

Outcome Measures

Primary Outcomes (14)

  • Recruitment rate

    The number of participants recruited from all eligible patients

    0 months

  • Drop-out rate

    Number of patients that drop-out from trial

    12 months

  • Decline rate

    Number of patients that decline to participate in the trial

    0 months

  • Change in physical activity levels

    Measured with International Physical Activity Questionnaire (IPAQ)

    0 and 4 months

  • Change in attitudes to exercise

    Measured with Determinates of Physical Activity Questionnaire (DPAQ)

    0 and 4 months

  • Trial Adherence

    Physical activity diary used to assess adherence

    12 months

  • Adverse Events

    The number of adverse events during the trial assessed using CTCAE

    12 months

  • Change in physiological fitness

    Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer

    0 and 4 months

  • Change in respiratory muscle strength

    Assessed with mean inspiratory pressure testing in cmH20

    0 and 4 months

  • Post-operative cardiopulmonary complications

    Cardiopulmonary complication rates as per ECCG definition.

    90-days post surgery

  • Post-operative non-cardiopulmonary complications

    Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.

    90-days post surgery

  • Post-operative length of stay

    Duration of post-operative stay in days

    90-days post surgery

  • Post-operative mortality

    Number of post-operative deaths

    90-days post surgery

  • Change in Quality of Life

    Assessed using QLQ C30 and OG25

    0, 4, 7 months

Study Arms (2)

Intervention

EXPERIMENTAL

A pre-operative personalised exercise programme (my-PEP).

Behavioral: Pre-operative Exercise Programme (my-PEP)

Control

OTHER

Standard care

Behavioral: Home Exercise Programme (HEP)

Interventions

Pre-operative Exercise Programme (my-PEP)BEHAVIORAL

A pre-operative personalised exercise programme (my-PEP) consisting of: 1) actions to promote exercise, using behavioural change techniques (BCTs), 2) home inspiratory muscle training (IMT), 3) a home exercise programme (HEP) - which is also current standard care, 4) a 4 week hospital-supervised aerobic and muscle strengthening programme (Hos-PEP) .

Intervention
Home Exercise Programme (HEP)BEHAVIORAL

Written advice on exercise at home

Control

Eligibility Criteria

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

You may qualify if:

  • Patients with oesophageal adenocarcinoma (OAC) who are scheduled for neoadjuvant chemotherapy and subsequent oesophagectomy.
  • Must have histological evidence of OAC
  • Must be capable of giving informed consent and complying with trial procedures.

You may not qualify if:

  • Patients with oesophageal squamous cell carcinoma.
  • Patients with concomitant illness or disability that makes them unsuitable for an exercise programme, as determined by a clinician (e.g. severe musculoskeletal or neurological disease, unstable angina, severe aortic stenosis, uncontrolled dysrhythmias and uncompensated heart failure).
  • WHO performance status 3 (capable of only limited self-care, confined to a bed or chair more that 50% of waking hours) or greater.
  • Grade 5 (too breathless to leave the house, or breathless when undressing) on MRC dyspnoea scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Postoperative ComplicationsAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 11, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

April 1, 2018

Last Updated

November 11, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)