Condition category
Cancer
Date applied
21/09/2010
Date assigned
27/10/2010
Last edited
15/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Rachel Garrod

ORCID ID

Contact details

Pulmonary Rehabilitation
Dulwich Hospital
East London Grove
London
SE22 8PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 6

Study information

Scientific title

The effect of post operative physical training on activity after curative surgery for Non Small Cell Lung Cancer: Restoring Activity Post Surgery (RAPS)

Acronym

RAPS

Study hypothesis

Does structured, physiotherapy led cycle ergometry strength training and a home walking programme, provided after curative surgery for lung cancer, result in improved activity at 4 weeks post discharge compared with usual care?

Ethics approval

East London Research Ethics Committee 1 (previously: East London & The City Research Ethics Committee Alpha) approved on the 12th of August 2010 (ref: 10/H0704/36)

Study design

Randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Non Small Cell Lung Cancer NSCLC)

Intervention

Patients will be randomised to:
1. Intervention Group: Training programme
1.1. Structured, physiotherapy-led cycle ergometry strength training programme once a day during inpatient stay
Symptom limited constant load cycle ergometry protocol: Following patient familiarisation with the ergometer, correct seat adjustment (recording seat height/position), patient completes warm-up phase during 0-2 minutes consisting of unloaded pedalling at 50-60rpm. Intensity of cycling is increased steadily during the 3rd minute to achieve max 60-90% Heart Rate Reserve (Target HR range = ([HRmax – HRrest] x percent intensity) + HRrest but also taking account of the following correction factor: 12/25% reduction in pre-op max load for Lobectomy/Pneumonectomy (Pelletier et al., 1990. Thorax 45(7): 497; 502). Patients will be advised to exercise at an intensity relating to Borg CR10 Breathlessness Scale (BBS) 3-4 and Borg Rating of Perceived Exertion (RPE) 13-15, pedalling rate should be held between 50-60 rpm. Patient should aim to complete >5 minutes Day 1 Post-Op, increasing to maximal duration 30 minutes at Day 5. Warm-down of at least 2 minutes unloaded pedalling until observed HR/SpO2% return towards resting values (~10 bpm of rest).
1.2. Home walking programme
Daily – aiming to get patients to achieve 30 mins walking per day so self-managed with bi-weekly phone calls from research tea

2. Control Group: Usual care

Follow up for all arms is 4 weeks post discharge.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Physical activity monitoring (time spent in moderate intensity activity measured using Actiwatch). The Actiwatch spectrum (Phillips Respironics) is worn like a wristwatch. It records the amplitude of physical activity. Data are downloaded by the researchers and the patient needs to do nothing other than wear it. Actiwatch data is collated daily for a period of three days pre-operatively, during in-patient stay to a maximum of 5 days and 3 days before the 4 week follow up.

Secondary outcome measures

1. Quadriceps muscle strength– measured as maximum voluntary contraction force
2. Exercise tolerance using Incremental Shuttle Walk Test
3. Quality of Life using EORTC and SF36 questionnaires
4. Length of hospital stay
5. Post-operative complications

Outcomes are measured pre-operatively, 5 days post-operatively (or sooner if discharge is earlier – then on day of discharge), and 4 weeks post-operatively.

Overall trial start date

01/09/2010

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (either sex) with lung cancer referred for curative lung resection (lobectomy and or pneumonectomy) via open thoracotomy or Video Assisted Thoracotomy (VATS).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

125

Participant exclusion criteria

1. Patients who have open and closed thoracotomy performed but no other surgical procedure
2. Admission greater than 48 hours to Intensive Care Unit post surgery

Recruitment start date

01/09/2010

Recruitment end date

30/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pulmonary Rehabilitation
London
SE22 8PT
United Kingdom

Sponsor information

Organisation

Kings College NHS Foundation Trust (UK)

Sponsor details

Jennie Lee House
34 Love Walk
Denmark Hill
London
SE5 5AD
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

British Lung Foundation (UK) - (ref: CAN09/1)

Alternative name(s)

BLF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24703523

Publication citations

Additional files

Editorial Notes