Does neuromuscular electrical stimulation of the proximal leg muscles improve leg muscle endurance, exercise endurance and activity levels in people with lung cancer?
| ISRCTN | ISRCTN86814835 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86814835 |
| Secondary identifying numbers | N0192170447 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 17/08/2012
- 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
Not provided at time of registration
Contact information
Dr Vincent Crosby
Scientific
Scientific
Hospital Palliative Care Team
E Floor East Block
University Hospital NHS Trust
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 |
|---|---|
| matthew.maddocks@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does neuromuscular electrical stimulation (NMES) of the thigh muscles of people with lung cancer improve muscle endurance, exercise endurance and physical activity levels as assessed by exercise on a Cybex machine, the endurance shuttle walking test (ESWT) and an ActivPal monitor respectively? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Lung |
| Intervention | A pilot study. Block randomisation to one of two groups. Group 1: 4 weeks with NMES device Group 2:- 4 weeks without device followed by 4 weeks with device |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/11/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 16 |
| Key inclusion criteria | 16 people with non-small cell cancer and an East Oncology Group (EOG) performance status of 0 to 1 and who have lost less than 10% of their normal body weight. |
| Key exclusion criteria | 1. Pain or pathology limiting walking ability for the shuttle walking tests or limiting leg exercise on the cybex machine 2. History of ischaemic heart disease 3. Radiotherapy or chemotherapy in the previous 4 weeks as this may increase fatigue 4. Presence of a pacemaker - because the NMES device delivers a small electrical current, it is possible that this will interfere with the functioning of the pacemaker |
| Date of first enrolment | 02/11/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hospital Palliative Care Team
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Queen's Medical Centre University Hospital NHS Trust (UK)
No information available
Nottingham Healthcare Trust (UK)
No information available
NHS R&D Support Funding
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2009 | Yes | No |
