Condition category
Respiratory
Date applied
17/12/2010
Date assigned
18/02/2011
Last edited
02/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uhl-tr.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes