Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000986471
Ethics application status
Approved
Date submitted
22/07/2016
Date registered
27/07/2016
Date last updated
5/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the feasibility and uptake of adding a behaviour change interventionthat aims to reduce sedentary time, to a standard pulmonary rehabilitation program, in people with chronic obstructive pulmonary disease
Scientific title
Exploring the feasibility and uptake of adding a behaviour change intervention that aims to reduce sedentary time, to a standard pulmonary rehabilitation program, in people with chronic obstructive pulmonary disease
Secondary ID [1] 287056 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 295540 0
Condition category
Condition code
Respiratory 295817 295817 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive 8 weeks of pulmonary rehabilitation coupled with 8 weeks of behaviour change intervention. The 8 week pulmonary rehabilitation program will consist of 2 supervised exercise training sessions a week. Each session will comprise 20 to 30 minutes of walking training and resistance exercises for the lower and upper limbs. These exercise training programs are considered usual care and are run by physiotherapists. In addition to pulmonary rehabilitation, participants in this study will be requested to attend weekly (i.e. total of 8), face-to-face, educational and goal-setting consultations (i.e. the behaviour intervention). These sessions will occur either immediately before or after a supervised exercise training class once a week. Each weekly consultation will last approximately 30 minutes. Participants will be asked to wear an activity tracker called the "UP2" (Jawbone, USA) for 2 to 3 days before each weekly consultation. During the weekly consultation, data from the activity tracker will be downloaded and reviewed. Each participant will receive counselling, using their own UP2 data, with the goal of reducing their sedentary time and increasing participation in physical activity at any intensity. The specific intervention message will be ‘if you have been sitting continuously for 30 minutes, stand up and move for 2 minutes’. Strategies to assist the participants achieve this goal will include motivational interviewing, feedback, vibration prompts from the UP2 and ideas to overcome barriers. A similar intervention has been shown to be effective in reducing sedentary time in healthy older adults, aged between 60 and 92 years. Attendance to weekly consultations will be documented so that adherence can be monitored.
Intervention code [1] 292286 0
Behaviour
Intervention code [2] 292287 0
Rehabilitation
Intervention code [3] 295401 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295510 0
Feasibility / uptake of adding a behaviour change intervention to a standard pulmonary rehabilitation program (composite primary outcome). During the assessments and intervention period, feasibility / uptake will be measured by taking notes of (i) the proportion of people who were approached to participate who consent to participate (ii) the proportion of people who commenced the intervention and also completed the intervention; (iii) the average number of sessions attended by the sample; (iv) the proportion of people who completed baseline assessments, post-intervention assessments and each component of the intervention; and (v) the proportion of people who reported adverse events such as skin irritation associated with monitor use.
Timepoint [1] 295510 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [1] 315736 0
Sedentary time and walking-based physical activity (composite secondary outcome). These will be assessed by the ActivPAL (PAL Technologies Ltd, UK). Participants will be asked to wear the monitor for 7 consecutive days, throughout waking hours. They will be instructed to remove the monitor to sleep and during showering and swimming activities. Data collected over these 7 days will be averaged for analysis. The ActivPAL is a small (0.7 x 5.3 x 3.5 cm) and lightweight (20 g) uniaxial monitor that has been validated to assess physical activity in people with COPD. The monitor attaches to the anterior aspect of the right thigh and combines data pertaining to gravitational acceleration and acceleration from segmental movement of the thigh. Time spent in sedentary behaviour is detected as time spent in supine and sitting.
Timepoint [1] 315736 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [2] 315737 0
Exercise capacity (six-minute walk distance)
Timepoint [2] 315737 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [3] 315738 0
Health-related quality of life (Chronic Respiratory Disease Questionnaire [CRDQ])
Timepoint [3] 315738 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [4] 315739 0
Illness perception (Revised Illness Perception Questionnaire [IPQ-R]).
Timepoint [4] 315739 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [5] 325925 0
Feelings of anxiety and depression (the Hospital Anxiety and Depression Scale [HADS])
Timepoint [5] 325925 0
Baseline and after 8 weeks of intervention commencement

Eligibility
Key inclusion criteria
Adults with stable COPD who have been referred to a pulmonary rehabilitation program at any of the recruitment sites.
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participation in an exercise training program in the previous 12 months; any co-morbid condition that limits their capacity participate in land-based supervised exercise training; cognitive decline and/or an inability to understand spoken and written English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations have not been undertaken as the main purpose of this study is to collect pilot data to inform sample size calculations for a future project grant. We will aim to include 12 participants. To account for possible attrition, we will inflate the sample size by 25% when recruiting participants. Therefore, the number of participants recruited will be 15. All analyses will be performed using the SPSS, version 24.0. Normality in the distribution of data will be checked by the Shapiro-Wilk test. Differences between baseline and post-intervention data will be assessed using either paired t-tests or the Wilcoxon test. A p value < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2017
Actual
Date of last participant enrolment
Anticipated
2/03/2018
Actual
Date of last data collection
Anticipated
30/03/2018
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291616 0
University
Name [1] 291616 0
School of Physiotherapy and Exercise Science (Curtin University)
Country [1] 291616 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Physiotherapy and Exercise Science, Curtin University
GPO Box U1987, Perth, WA
6845, Australia
Country
Australia
Secondary sponsor category [1] 290287 0
Other
Name [1] 290287 0
Community Physiotherapy Services
Address [1] 290287 0
Level 2, 151 Wellington Street
East Perth, WA
6000, Australia
Country [1] 290287 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293148 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [1] 293148 0
Department of Health
189 Royal Street
East Perth WA 6004
Ethics committee country [1] 293148 0
Australia
Date submitted for ethics approval [1] 293148 0
26/08/2016
Approval date [1] 293148 0
03/02/2017
Ethics approval number [1] 293148 0

Summary
Brief summary
This study will not test a hypothesis. It will report the feasibility and uptake of adding a behaviour change intervention, which aims to reduce sedentary time of people with COPD, to a standard pulmonary rehabilitation program. The goal is to provide pilot data to support an NHMRC project grant application (in 2017).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58662 0
A/Prof Kylie Hill
Address 58662 0
School of Physiotherapy and Exercise Science, Curtin University
GPO Box U1987
Perth, WA, 6845
Country 58662 0
Australia
Phone 58662 0
+61 8 9266 2774
Fax 58662 0
+61 8 9266 3699
Email 58662 0
[email protected]
Contact person for public queries
Name 58663 0
A/Prof Kylie Hill
Address 58663 0
School of Physiotherapy and Exercise Science, Curtin University
GPO Box U1987
Perth, WA, 6845
Country 58663 0
Australia
Phone 58663 0
+61 8 9266 2774
Fax 58663 0
+61 8 9266 3699
Email 58663 0
[email protected]
Contact person for scientific queries
Name 58664 0
A/Prof Kylie Hill
Address 58664 0
School of Physiotherapy and Exercise Science, Curtin University
GPO Box U1987
Perth, WA, 6845
Country 58664 0
Australia
Phone 58664 0
+61 8 9266 2774
Fax 58664 0
+61 8 9266 3699
Email 58664 0
[email protected]

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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