A study to establish reference values for the incremental shuttle walk test in a healthy population
| ISRCTN | ISRCTN70138213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70138213 |
| Secondary identifying numbers | 10860 |
- Submission date
- 17/12/2010
- Registration date
- 18/02/2011
- Last edited
- 02/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Samantha Harrison
Scientific
Scientific
CLAHRC Research Office, Ward 25
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| Phone | +44 (0)116 258 3652 |
|---|---|
| samantha.harrison@uhl-tr.nhs.uk |
Study information
| Study design | Single-centre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A single-centre observational study to establish reference values for the incremental shuttle walk test in a healthy population |
| Study acronym | ISWT |
| Study objectives | To establish normal values for the Incremental Shuttle Walk Test (ISWT) in a group of healthy adults who are aged between 40 and 90 years. |
| Ethics approval(s) | Leicestershire, Northamptonshire and Rutland Research Ethics Committee 2, 13/01/2010, ref: 09/H0402/108 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Subjects attend an initial visit at Glenfield Hospital where once they have consented to participate in the study all the necessary subjective information, including height, weight and blood pressure, will be obtained. Subjects also complete a lung function test and a muscle strength test during this first visit. Once subjects' medical notes have been received and reviewed, subjects attend a second visit at Glenfield Hospital. During the second visit they complete the exercise performance test and fill in three questionnaires. In the time between the two study visits subjects wear an activity monitor on two consecutive weekdays. Incremental Shuttle Walk Test (ISWT): Before commencing the test a standardised set of verbal instructions will be played to the subject via a CD player. The test requires participants to walk up and down a 10 metre course which is marked out by two cones placed 9 metres apart. The walking speed is externally paced and is dictated by a pre-recorded audio signal (a 'bleep') which is played on a CD player. The test is maximal and progressive. The test will stop when the subject completes the test, their legs feel too tired, they are too breathless to continue or they fail to keep up with the speed of the test. A failure to keep up with the speed of the test is characterised by a subject being more than 0.5 metre away from the next cone after one verbal instruction to speed up has been given. Subjects will be asked to speed up if they fail to be within 0.5 metre of the next cone before the 'bleep'. HR and Sa02 will be monitored via a pulse oximeter throughout the ISWT and recorded pre and post the ISWT. The Borg breathlessness score will also recorded pre and post and rating of physical exertion (RPE) will be recorded post the ISWT. The test is repeated after a 30-minute rest. |
| Intervention type | Other |
| Primary outcome measure | Incremental Shuttle Walk Test (ISWT) measured at baseline and repeated after a 30-minute rest. |
| Secondary outcome measures | Measured on a one-off occassion: 1. Isometric quadriceps strength measured using a Kern CH 50 K 100 Strain Gauge 2. Physical activity measured using the Duke Physical Activity Questionnaire and The Physical Activity Questionnaire 3. Anxiety and depression measured using The Hospital Anxiety and Depression Scale (HADS) |
| Overall study start date | 01/02/2010 |
| Completion date | 01/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Patients over the age of 40 years, either sex 2. Medical Research Council (MRC) grade of 1 or 2 3. Normal spirometry diagnosed by forced expiratory volume in one second (FEV1) greater than 80% or FEV1/forced vital capacity (FVC) ratio of greater than 70% of their predicted age group average (NICE, 2004; BTS, 2005) 4. Willingness to participate (informed consent) |
| Key exclusion criteria | 1. Subjects less than 40 years old or more than 90 years old 2. Subjects with any co-morbidities that affect their mobility 3. Subjects with known cardiovascular disease or any unstable cardiac conditions 4. Body mass index (BMI) less than 18.5 or greater than 40 kg/m2 (Food Standards Agency [FSA]) 5. Subjects with a resting systolic blood pressure (SBP) greater than 180 mmHg or resting diastolic blood pressure (DBP) greater than 100 mmHg 6. Subjects with pulmonary dysfunction diagnosed by FEV1 less than 80% or FEV1/FVC less than 70% of their predicted age group average (NICE, 2004; BTS, 2005) 7. Subjects without the capacity to give informed consent; if they are confused or if they are impaired by pain |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 01/11/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CLAHRC Research Office, Ward 25
Leicester
LE3 9QP
United Kingdom
LE3 9QP
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Carolyn Maloney
Gwendolen House
Gwendolen Road
Leicester
LE5 4PY
England
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| carolyn.maloney@uhl-tr.nhs.uk | |
| Website | http://www.uhl-tr.nhs.uk/ |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Hospital/treatment centre
University Hospitals of Leicester NHS Trust (UK) - Pulmonary Rehabilitation Department
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 | 01/09/2013 | Yes | No |
