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A behaviour-change intervention to reduce sedentary time in people with chronic obstructive pulmonary disease

A behaviour-change intervention to reduce sedentary time in people with chronic obstructive pulmonary disease: a randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001534471
Enrollment
70
Registered
2016-11-08
Start date
2016-12-21
Completion date
2019-05-01
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This multi-centre randomised controlled trial will investigate the effectiveness and feasibility of a six-week behaviour change intervention to reduce sedentary time in people with COPD. Eligible participants with COPD on the waiting list for pulmonary rehabilitation at Royal Prince Alfred Hospital and Prince of Wales Hospital, Sydney, will be randomised to either a six-week behaviour-change intervention to reduce sedentary time or to a sham intervention. The intervention uses goal setting and motivational interviewing techniques to determine individualised ways of replacing sedentary behaviour with light intensity physical activity. Outcomes will include sedentary time according to self-report and objective device-based measures, feasibility of the intervention, functional exercise capacity, quality of life, patient activation, and anxiety and depression. Semi-structured interviews will also be conducted to obtain qualitative data on participant satisfaction and acceptance of the different components of the intervention.

Interventions

The behaviour change intervention will consist of weekly sessions with a physiotherapist for six weeks. In Weeks 1, 3 and 6, participants will receive a one on one, face-to-face session in the setting of their choice (i.e., in the participants’ own home or at the pulmonary rehabilitation site) lasting approximately one hour. In the other three weeks of the intervention, participants will receive supportive phone calls of up to 30 minutes. All six sessions will be conducted by the same principal

The behaviour change intervention will consist of weekly sessions with a physiotherapist for six weeks. In Weeks 1, 3 and 6, participants will receive a one on one, face-to-face session in the setting of their choice (i.e., in the participants’ own home or at the pulmonary rehabilitation site) lasting approximately one hour. In the other three weeks of the intervention, participants will receive supportive phone calls of up to 30 minutes. All six sessions will be conducted by the same principal investigator, who has been trained in the use of the 'capability', 'opportunity', 'motivation' and 'behaviour' (COM-B) model and the Behaviour Change Wheel, to ensure that the intervention is delivered consistently across participants. During the initial session, a behavioural analysis will be conducted using the COM-B model to determine what needs to change (in terms of capability, opportunity and motivation) for each individual participant to achieve the two target behaviours and reduce their sedentary time. Participants will also be asked to report their stage of readiness for change and complete the Perceived Competence Scale, which assesses their feelings of competence about engaging in a heath behaviour. These two questionnaires have been adapted for the study to assist the principal investigator in tailoring the intervention to meet the individual needs and progress of each participant. Based on the behavioural analysis and the results of the questionnaires, appropriate behaviour change techniques will be selected to facilitate movement through the stages of readiness for change. These include: 1. Information about the health consequences of sedentary behaviour. Written and verbal education will be provided regarding the health risks associated with too much sedentary time, and how these risks can be reduced by replacing sitting and lying down with light intensity physical activity. 2. Guided goal setting to reduce sedentary time. Participants will be asked to implement one goal per week that involves replacing sitting or lying down with light intensity physical activity (e.g., “I am going to eat my breakfast standing up at the kitchen bench instead of sitting down at the table”), or standing up and moving for two minutes after 30 minutes of continuous sedentary time (e.g., “I am going to walk around the house for two minutes after 30 minutes of reading in bed”). The aim is to progress that goal over the intervention period, so that by the final week participants will have integrated six goals into their day to reduce sedentary time. Action planning will be used to specify when, where, and how participants will reduce their sedentary time. Participants will record their weekly goals and action plans in a workbook. 3. Self-monitoring and review of behaviour goals. The workbook will also contain a simple daily checklist that participants can use to self-monitor their goals (e.g., “Today, did you achieve your goal of eating breakfast standing up at the kitchen bench? Yes/No. If not, what was stopping you?”). Self-reported achievement of goals will be interpreted from this checklist. 4. Problem solving of barriers to achieving weekly goals. Participants will be prompted to identify potential barriers to reducing sedentary time, and to generate strategies to overcome these barriers. This may involve restructuring the home environment, advising on social support to enable more light intensity physical activity, or using intrinsic cues embedded in an activity to remind participants to break up prolonged bouts of sedentary time (e.g., using the television ad breaks as a prompt to stand and move up when watching television). 5. Feedback on sedentary time. The Jawbone UP3 (Jawbone, San Francisco, USA) is a commercially available accelerometer worn on the wrist that will be used to provide feedback on prolonged bouts of sedentary time. The device has a vibrating alert function and will be programmed to vibrate after 30 minutes of sustained inactivity. This real-time feedback aims to remind participants to move if they accumulate 30 minutes of sustained inactivity. Participants will be asked to wear the Jawbone during all waking hours for the six-week intervention period. 6. Motivational interviewing techniques. These will include positive reinforcement; using recollections of previous success with reducing sedentary time to inform new goals; addressing any maladaptive beliefs participants may have about COPD or about sedentary behaviour; and acknowledging any difficulties they may have and redirecting them towards a solution. Standardised definitions of the behaviour change techniques mentioned above can be found in the Behaviour Change Taxonomy. Compliance with the behaviour change intervention will be monitored by (1) keeping a register of attendance for face-to-face sessions and a log of call times for phone sessions, and (2) reviewing the participants’ workbook and daily checklist at each face-to-face session.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Medical diagnosis of chronic obstructive pulmonary disease (forced expiratory volume in one second (FEV1) / forced vital capacity ratio of < 0.7); Clinically stable, defined as no change in medication in the four weeks preceding recruitment; Able to mobilise independently with or without a walking aid; Expected to wait eight weeks or more on the waiting list for a pulmonary rehabilitation program.

Exclusion criteria

Have participated in a supervised exercise training program within the last six months; have limited spoken and/or written English which prevents them from participating in the intervention.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026