Restoring Activity Post Surgery (RAPS)

ISRCTN	ISRCTN07216922
DOI	https://doi.org/10.1186/ISRCTN07216922
Protocol serial number	Version 6
Sponsor	Kings College NHS Foundation Trust (UK)
Funder	British Lung Foundation (UK) - (ref: CAN09/1)

Submission date: 21/09/2010
Registration date: 27/10/2010
Last edited: 24/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-planned-exercise-programme-after-surgery-for-non-small-cell-lung-cancer-raps

Contact information

Dr Rachel Garrod
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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)
Study acronym	RAPS
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/04/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	125
Key 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).
Key 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
Date of first enrolment	01/09/2010
Date of final enrolment	30/04/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Pulmonary Rehabilitation

London
SE22 8PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			24/01/2022	No	Yes

Editorial Notes

24/01/2022: A link to plain English results was added.