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Trial registered on ANZCTR

Registration number

ACTRN12610000655044

Ethics application status

Approved

Date submitted

7/08/2010

Date registered

11/08/2010

Date last updated

12/03/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Consistency of the language of breathlessness between recalled and experimentally induced breathlessness in adults who are obese

Scientific title

Is the recalled sensation of breathlessness similar to the sensation experienced during exercise in adults who are overweight or obese?

Secondary ID [1]

No secondary ID

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

sensation of breathlessness

Condition category

Condition code

Diet and Nutrition

Obesity

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Submaximal exercise (2 minute step test). This test requires participants to step in place (march on the spot) raising the lifted knee to a height half way between the patella and the anterior iliac crest as many times as they can within 2 minutes. Standard heart rate and oxygen saturation will be monitored for safety. While the test has been shown to be a valid and reliable indicator of cardiovascular fitness levels in older adults and is performed as an alternative for people who cannot safely undergo common exercise tests or protocols, in this study, the 2-minute step test is not being used to assess the fitness level. It is being used to induce breathlessness in a group where exercise safety might be an issue. The test will be performed once only.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Lifestyle

Comparator / control treatment

no exercise (retrospective recall). Participants will rest quietly in a chair for 5 minutes and then undertake a structured interview for the sensation of breathlessness while sitting comfortably in a chair. This interview assesses the recalled sensation of breathlnessness on an average day.

Control group

Active

Outcomes

Primary outcome [1]

Intensity and unpleasentness of breathlnessness visual analogue scales (VAS)

Timepoint [1]

baseline and immediately after cessation of exercise

Primary outcome [2]

Descriptors of breathlessness (volunteered and selected from list of 15 statements)

Timepoint [2]

baseline and immediately after cessation of exercise

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Body mass index (BMI) > 25kg/m2
Willing and able to provide written consent

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Body mass index (BMI) < 25kg/m2
Known pregancy
Chronic obstructive lung diseases (Forced expiratory volume in one second (FEV1) <80 per cent predicted (% pred), FEV1/Forced vital capacity (FVC) <0.7)
Prior diagnosis of heart diseases, lung cancer, severe short term memory loss or memory decline or visual impairment resulting in an inability to see the visual analogue scale (VAS)
Unable to understand English (written, spoken) or speak English

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants will be recruited from the UniSA Exercise Physiology Clinic, Royal Adelaide Hospital Obesity Clinic and previous volunteers with overweight/obesity associated with the UniSA Nutritional Physiology Research Centre (NPRC) who have expressed the willingness to be contacted for future studies. Once consent and confirmation on inclusion /exclusion criteria are completed, participants will complete baseline assessments and then complete the 2 minute step test, after which post exercise assessments will be conducted. This is a same subject, pre -post test design.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

This is a same subject design where all participants receive the same interventions in the same order (recalled sensation at rest followed by sensation of breathlnessness induced by exercise ).

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

23/08/2010

Actual

19/11/2010

Date of last participant enrolment

Anticipated

Actual

5/07/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5000

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Address [1]

City East Campus, North Terrace
Adelaide, South Australia 5000

Country [1]

Australia

Primary sponsor type

University

Name

University of South Australia

Address

City East Campus, North Terrace
Adelaide, South Australia 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committe, University of South Australia

Ethics committee address [1]

Mawson Lakes Campus
University of South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/08/2008

Ethics approval number [1]

P202/08

Summary

Brief summary

Emerging evidence has suggested that the sensation of breathlessness includes domains for intensity, sensory quality (descriptors) and unpleasantness).The sensation of breathlessness differs between people with and without chronic medical conditions and is thought to reflect the different mechanisms initiating the sensation. While breathlessness is common in people who are overweight/ obese, to date, no previous study could be found which specifically describe the sensory quality of breathlessness in this population. It is unclear whether the sensation of breathlessness experienced by people who are overweight/obese is unpleasant and if so, does this unpleasant sensation encourage early cessation of physical activity. There is a difference in the sensory quality between recall and exercise-induced breathlessness in people with chronic pulmonary disease. This might be simply due to the difference in the context under which breathlessness was recalled or induced. However, influence of the memory, emotion, expectation, and other psychological factors could very well play a role.

 This uncontrolled pre-post design aims to determine whether the recalled sensation of breathlessness differs from the sensation induced by exercise in adults with overweight or obesity.
Sixty people between the ages of 18 and 80 years with overweight /obesity (BMI kg/m2 >25) will be invited to participate in this study. Participants will be excluded if they have a prior diagnosis of heart disease, lung cancer, chronic obstructive pulmonary disease, memory or cognitive disorders or a visual disorder which limits the ability to interpret visual analogue scales.
After height, body mass and body mass index have been assessed, participants will complete a structured interview for the sensation of breathlessness before and immediately after breathlessness in induced by a 2 minute step test. This interview includes assessment of breathlessness intensity (visual analogue scale), unpleasantness(visual analogue scale) and sensory quality (descriptors volunteered and selected from a pre-existing list of 15 breathlessness statements). 
Descriptive analysis (e.g. mean, standard deviation, frequency)  are planned for age, gender, weight, height and BMI. Paired t-test will be performed between baseline and exercise-induced VAS scores to determine the degree of breathlessness induced by the 2-minute step test. The frequency of descriptors volunteered and endorsed by each subject will be allocated into sensory categories. Language data will then be converted to a binary form (subjects do or do not volunteer or endorse a particular language category). Within each sensory category, the difference between the recalled and exercise-induced language will be compared using McNemar’s test, with p < 0.05 regarded as significant.

Trial website

nil

Trial related presentations / publications

Williams MT, Cafarella P, Olds T et al. Affective descriptors of the sensation of breathlessness are more highly associated with severity of impairment than physical descriptors in people with chronic obstructive pulmonary disease. Chest. Published Online first: 4 Mar 2010. doi: 10.1378/chest.09-2498 Williams MT, Garrard A, Cafferela P, Petkov J, Frith P. Quality of recalled dyspnoea is different from exercise-induced dyspnoea: an experimental study Australian Journal of Physiotherapy 2009 55;177-183 Williams MT, Cafarella P, Olds T, Petkov J, Frith P. The language of breathlessness differentiates between patients with chronic obstructive pulmonary disease and age-matched adults. Chest 2008;134:489-496
Gerlach Y, Williams MT, Coates A. Weighing up the evidence –A systematic review of measures used for the sensation of breathlessness in obesity. International Journal of Obesity  2013 37:341-349
Gerlach Y, Williams MT, Coates A. Measures of the sensation of breathlessness in people with obesity: a systematic review. Physiotherapy Conference Brisbane October 27-30th 2011.

Public notes

Contacts

Principal investigator

Name

Dr Marie Williams

Address

School of Population Health,Division of Health Sciences, University of South Australia, P4-27D Playford Building, City East Campus , Adelaide , South Australia 5000

Country

Australia

Phone

+61 8 8302 1153

Fax

marie.williams@unisa.edu.au

Contact person for public queries

Name

Dr Marie Williams

Address

School of Population Health,Division of Health Sciences, University of South Australia, P4-27D Playford Building, City East Campus , Adelaide , South Australia 5000

Country

Australia

Phone

+61 8 8302 1153

Fax

+61 8 8302 2794

marie.williams@unisa.edu.au

Contact person for scientific queries

Name

Dr Marie Williams

Address

School of Population Health,Division of Health Sciences, University of South Australia, P4-27D Playford Building, City East Campus , Adelaide , South Australia 5000

Country

Australia

Phone

+61 8 8302 1153

Fax

+61 8 8302 2794

marie.williams@unisa.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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