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
Protocol serial number	10860
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	University Hospitals of Leicester NHS Trust (UK) - Pulmonary Rehabilitation Department

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

CLAHRC Research Office, Ward 25
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Phone	+44 (0)116 258 3652
Email	samantha.harrison@uhl-tr.nhs.uk

Study information

Primary study design	Observational
Study design	Single-centre observational study
Secondary study design	Single-centre
Study type	Participant 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(s)	Incremental Shuttle Walk Test (ISWT) measured at baseline and repeated after a 30-minute rest.
Key secondary outcome measure(s)	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)
Completion date	01/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

CLAHRC Research Office, Ward 25

Leicester
LE3 9QP
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes