Contact information
Type
Scientific
Primary contact
Miss Samantha Harrison
ORCID ID
Contact details
CLAHRC Research Office
Ward 25
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
+44 (0)116 258 3652
samantha.harrison@uhl-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10860
Study information
Scientific title
A single-centre observational study to establish reference values for the incremental shuttle walk test in a healthy population
Acronym
ISWT
Study hypothesis
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
Leicestershire, Northamptonshire and Rutland Research Ethics Committee 2, 13/01/2010, ref: 09/H0402/108
Study design
Single-centre observational study
Primary study design
Observational
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/02/2010
Overall trial end date
01/11/2011
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/02/2010
Recruitment end date
01/11/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CLAHRC Research Office, Ward 25
Leicester
LE3 9QP
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
c/o Carolyn Maloney
Gwendolen House
Gwendolen Road
Leicester
LE5 4PY
United Kingdom
+44 (0)116 258 4109
carolyn.maloney@uhl-tr.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospitals of Leicester NHS Trust (UK) - Pulmonary Rehabilitation Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23959208
Publication citations
-
Results
Harrison SL, Greening NJ, Houchen-Wolloff L, Bankart J, Morgan MD, Steiner MC, Singh SJ, Age-specific normal values for the incremental shuttle walk test in a healthy British population., J Cardiopulm Rehabil Prev, 33, 5, 309-313, doi: 10.1097/HCR.0b013e3182a0297e.