Restoring Activity Post Surgery (RAPS)
| ISRCTN | ISRCTN07216922 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07216922 |
| Secondary identifying numbers | Version 6 |
- 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
Contact information
Dr Rachel Garrod
Scientific
Scientific
Pulmonary Rehabilitation
Dulwich Hospital
East London Grove
London
SE22 8PT
United Kingdom
Study information
| Study design | Randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/09/2010 |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Pulmonary Rehabilitation
London
SE22 8PT
United Kingdom
SE22 8PT
United Kingdom
Sponsor information
Kings College NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Jennie Lee House
34 Love Walk
Denmark Hill
London
SE5 5AD
England
United Kingdom
"ROR" |
https://ror.org/01n0k5m85 |
|---|
Funders
Funder type
Charity
British Lung Foundation (UK) - (ref: CAN09/1)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BLF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | |
| Plain English results | 24/01/2022 | No | Yes |
Editorial Notes
24/01/2022: A link to plain English results was added.
