COPDNCT03660644
Physical Activity Following Pulmonary Rehabilitation in COPD
A study testing WhatsApp, Pedometer and Step Diary in people with COPD and Physical Activity, run by University of Lincoln at 1 site in United Kingdom.
Trial summary
The aim of this feasibility study is to identify the acceptability of an intervention designed to promote physical activity following pulmonary rehabilitation for individuals with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- COPD, Physical Activity
- What is being tested?
- WhatsApp, Pedometer and Step Diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cluster level
- Pulmonary rehabilitation programmes within Lincolnshire Community Health Services (NHS trust).
- Permission from the lead healthcare professionals of the pulmonary rehabilitation programme for the programme to be involved in the study.
- Patient level
- Adults (age range: 30-100 years) with COPD who are enrolled in pulmonary rehabilitation within Lincolnshire Community Health Services (NHS trust).
- Provide informed consent for their outcome data to be collected.
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- Patients (for telephone interviews)
- Have access to a telephone.
- Adults (age range: 30-100 years) with COPD who are enrolled in pulmonary rehabilitation within Lincolnshire community health services (NHS trust).
- Provide informed consent to participate in a telephone interview (including patients who do/do not consent for their outcome data to be collected).
- Health care professionals
- Involved in delivering the pulmonary rehabilitation programmes allocated to the Intervention Group within Lincolnshire Community Health Services (NHS trust).
- Provide informed consent to participate in a focus group.
- WhatsApp group leaders
- Volunteers (who were members of local COPD support groups, whom held the position of Chair, Treasurer or Secretary, or were ordinary members, and in general, sufficiently stable to be a proactive and regular member of the group)
- Provide informed consent to lead the WhatsApp groups.
Who cannot join
- Cluster level
- Pulmonary rehabilitation programmes which are not within Lincolnshire Community Health Services (NHS trust).
- The lead health care professionals of the pulmonary rehabilitation programmes are unwilling for the programme to be involved in the study.
- Patient level
- Not enrolled on a pulmonary rehabilitation programme within Lincolnshire Community Health Services (NHS trust) or those who drop out of pulmonary rehabilitation following enrolment.
- Unable/unwilling to provide informed consent for their outcome data to be collected.
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- Involved in another research study including the use of an intervention to promote physical activity.
- Patients (telephone interviews)
- Do not have access to a telephone.
- Not enrolled on a pulmonary rehabilitation programme within Lincolnshire Community Health Services (NHS trust) or those who drop out of pulmonary rehabilitation following enrolment.
- Unable/unwilling to provide informed consent to participate in a telephone interview.
- Health care professionals
- Not involved in delivering the pulmonary rehabilitation programmes allocated to the Intervention Group.
- Unable/unwilling to provide informed consent to participate in a focus group.
- WhatsApp group leaders
- Not volunteers (and have not been involved in local COPD support groups, have not held the position of Chair, Treasurer or Secretary, have not been ordinary members, and in general, are not sufficiently stable to be a proactive and regular member of the group)
- Unable/unwilling to provide informed consent to lead the WhatsApp groups.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS pulmonary rehabilitation clinics across Lincolnshire
Lincoln, Lincolnshire
About this study
Official title: Physical Activity Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The aim of this feasibility study is to identify the acceptability of an intervention designed to promote physical activity following pulmonary rehabilitation for individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants in the intervention group will be provided with pedometers and step diaries and added to a WhatsApp group with other graduates of pulmonary rehabilitation for 52 weeks.
Read the detailed description
Evidence suggests that physical activity is not maintained following pulmonary rehabilitation for individuals with COPD. Peer social support, feedback about physical progression and recognition of opportunities to stay active following pulmonary rehabilitation have been identified as facilitators to physical activity following pulmonary rehabilitation. The proposed feasibility study has incorporated these factors into the intervention.
This is a mixed-methods study including a feasibility cluster randomised controlled trial and a qualitative process evaluation. Clusters will be pulmonary rehabilitation programmes across Lincolnshire Community Health Services, NHS Trust (n=8), randomly allocated to the Intervention or Control. Patients in the Intervention group will receive a multi component intervention following pulmonary rehabilitation (pedometer, step diary and WhatsApp) and patients in the Control group will receive standard care following pulmonary rehabilitation.
The primary objective is to identify and report the acceptability of the intervention for patients. The secondary objectives are to: 1) gather information on recruitment and consent rates of patients who are eligible and willing to participate, and to monitor retention of participants throughout the study; 2) understand the patients' and health care professionals' experience and views of the intervention and research procedures; 3) identify and report intervention fidelity throughout the study; 4) provide an estimate of likely changes in the proposed primary outcome for the full randomised controlled trial (average daily step count at 52 weeks following pulmonary rehabilitation) and other secondary health outcomes; 5) obtain the necessary statistical parameters to inform sample size calculations in a future definitive cluster randomised controlled trial. The results from the feasibility study will inform the design of a definitive trial, including whether the specific intervention has the potential to promote physical activity.
- Conditions
- COPD, Physical Activity
- Being tested
- WhatsApp, Pedometer and Step Diary
- Keywords
- COPD, Physical Activity, Pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhatsApp, Pedometer and Step DiaryBehavioural
Participants will be provided with a daily step diary and added to a group chat on WhatsApp. The group chat will be populated by other members of pulmonary rehabilitation programme (cluster) and the WhatsApp group leader will encourage participants to keep active. Participants will be encouraged to record the number of steps walked in a paper diary at the end of each day (i.e. prior to bedtime). This diary will simply have three columns: day of the week; number of steps; comments (optional).
The intervention will last 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| WhatsApp, Pedometer and Step Diary | Experimental | Pedometer, step diary and WhatsApp following pulmonary rehabilitation Receives: Behavioral: WhatsApp, Pedometer and Step Diary |
| Control | No intervention | Usual care following pulmonary rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
The number of patients who comply with the intervention will be measured
Measured: 55 weeks
Secondary outcomes (15)
Recruitment rates
The time taken to achieve planned sample size (clusters, participants) will be measured
Measured: Up to 26 weeks (approximately)
Consent rates
The number of eligible patients willing to consent to take part in the study will be measured
Measured: Up to 26 weeks (approximately)
Attrition rates
The number of patients who withdraw from the study will be measured
Measured: Up to 55 weeks (study completion)
Semi-structured telephone interviews with subsets of patients
Patients' experience/views of the research procedures and intervention will be measured
Measured: At relevant intervals up to 55 weeks (study completion)
Focus groups with health care professionals
Healthcare professionals' experience/views of the research procedures and intervention will be measured
Measured: At relevant intervals up to 55 weeks (study completion)
Content of anonymised WhatsApp chat
The WhatsApp chats will be sent to the research team to measure intervention fidelity.
Measured: At 4 week intervals, up to 55 weeks (study completion)
WhatsApp Checklist
The WhatsApp checklists will be sent to the research team to measure the intervention fidelity.
Measured: At 4 week intervals, up to 55 weeks (study completion)
Step diary (self-reported)
Patients' step diaries will be collected to assess the intervention fidelity.
Measured: 55 weeks (study completion)
Activity levels
Activity levels will be measured by an activity monitor (Actigraph wGT3X-BT). Physical activity will be specified for:
- Time spent in different activity intensities
- Time spent sedentary
- Daily and weekly steps
- Weekly Vector Magnitude Units
Measured: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
PROactive tool
The PROactive tool measures both physical activity amount (from the activity monitor) and physical activity difficulty to compute a reliable measure of physical activity in COPD.
Measured: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
Sleep levels
Sleep will be measured by an activity monitor (Actigraph wGT3X-BT).
Sleep will be specified for:
- Sleep latency
- Total sleep time
- Wake after sleep onset
- Sleep efficiency.
Measured: Baseline, 12 and 52 weeks after pulmonary rehabilitation
Sleep (self-reported sleep habits)
In conjunction with wearing an activity monitor, participants will report the:
- Time went to bed
- Time taken to fall asleep
- Time woke up
Measured: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
Incremental Shuttle Walk Test (ISWT)
The ISWT will measure participants functional capacity.
Measured: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
Chronic Respiratory Questionnaire (CRQ)
The CRQ will measure patients' disease specific quality of life.
Measured: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
Hospital Anxiety and Depression Scale (HADS)
HADS will measure patients' psychological well-being.
Measured: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start13 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom, British Lung Foundation, University College, London, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Hayley Robinson, MSc, Principal investigator, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660644
- Sponsor's protocol ID
- 180203
- Status last verified
- Sep 2019
- First submitted
- 17 May 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03660644
- Acronym / sponsor ID
- 180203
- Conditions
- COPD, Physical Activity
- Keywords
- COPD, Physical Activity, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom, British Lung Foundation, University College, London, University of Oxford
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this feasibility study is to identify the acceptability of an intervention designed to promote physical activity following pulmonary rehabilitation for individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants in the intervention group will be provided with pedometers and step diaries and added to a WhatsApp group with other graduates of pulmonary rehabilitation for 52 weeks.
Detailed description
Evidence suggests that physical activity is not maintained following pulmonary rehabilitation for individuals with COPD. Peer social support, feedback about physical progression and recognition of opportunities to stay active following pulmonary rehabilitation have been identified as facilitators to physical activity following pulmonary rehabilitation. The proposed feasibility study has incorporated these factors into the intervention.
This is a mixed-methods study including a feasibility cluster randomised controlled trial and a qualitative process evaluation. Clusters will be pulmonary rehabilitation programmes across Lincolnshire Community Health Services, NHS Trust (n=8), randomly allocated to the Intervention or Control. Patients in the Intervention group will receive a multi component intervention following pulmonary rehabilitation (pedometer, step diary and WhatsApp) and patients in the Control group will receive standard care following pulmonary rehabilitation.
The primary objective is to identify and report the acceptability of the intervention for patients. The secondary objectives are to: 1) gather information on recruitment and consent rates of patients who are eligible and willing to participate, and to monitor retention of participants throughout the study; 2) understand the patients' and health care professionals' experience and views of the intervention and research procedures; 3) identify and report intervention fidelity throughout the study; 4) provide an estimate of likely changes in the proposed primary outcome for the full randomised controlled trial (average daily step count at 52 weeks following pulmonary rehabilitation) and other secondary health outcomes; 5) obtain the necessary statistical parameters to inform sample size calculations in a future definitive cluster randomised controlled trial. The results from the feasibility study will inform the design of a definitive trial, including whether the specific intervention has the potential to promote physical activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WhatsApp, Pedometer and Step Diary | Experimental | Behavioral: WhatsApp, Pedometer and Step DiaryPedometer, step diary and WhatsApp following pulmonary rehabilitation |
| Control | No intervention | –Usual care following pulmonary rehabilitation. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Cluster level
- Pulmonary rehabilitation programmes within Lincolnshire Community Health Services (NHS trust).
- Permission from the lead healthcare professionals of the pulmonary rehabilitation programme for the programme to be involved in the study.
- Patient level
- Adults (age range: 30-100 years) with COPD who are enrolled in pulmonary rehabilitation within Lincolnshire Community Health Services (NHS trust).
Key exclusion criteria (17 listed)
- Cluster level
- Pulmonary rehabilitation programmes which are not within Lincolnshire Community Health Services (NHS trust).
- The lead health care professionals of the pulmonary rehabilitation programmes are unwilling for the programme to be involved in the study.
- Patient level
- Not enrolled on a pulmonary rehabilitation programme within Lincolnshire Community Health Services (NHS trust) or those who drop out of pulmonary rehabilitation following enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WhatsApp, Pedometer and Step DiaryParticipants will be provided with a daily step diary and added to a group chat on WhatsApp. The group chat will be populated by other members of pulmonary rehabilitation programme (cluster) and the WhatsApp group leader will encourage participants to keep active. Participants will be encouraged to record the number of steps walked in a paper diary at the end of each day (i.e. prior to bedtime). This diary will simply have three columns: day of the week; number of steps; comments (optional). The intervention will last 52 weeks. | Behavioural | WhatsApp, Pedometer and Step Diary |
Primary outcome
Acceptability of the intervention
Time frame: 55 weeks
The number of patients who comply with the intervention will be measured
15 secondary outcomes
Recruitment rates
Time frame: Up to 26 weeks (approximately)
Consent rates
Time frame: Up to 26 weeks (approximately)
Attrition rates
Time frame: Up to 55 weeks (study completion)
Semi-structured telephone interviews with subsets of patients
Time frame: At relevant intervals up to 55 weeks (study completion)
Focus groups with health care professionals
Time frame: At relevant intervals up to 55 weeks (study completion)
Content of anonymised WhatsApp chat
Time frame: At 4 week intervals, up to 55 weeks (study completion)
WhatsApp Checklist
Time frame: At 4 week intervals, up to 55 weeks (study completion)
Step diary (self-reported)
Time frame: 55 weeks (study completion)
Activity levels
Time frame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
PROactive tool
Time frame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
Sleep levels
Time frame: Baseline, 12 and 52 weeks after pulmonary rehabilitation
Sleep (self-reported sleep habits)
Time frame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
Incremental Shuttle Walk Test (ISWT)
Time frame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
Chronic Respiratory Questionnaire (CRQ)
Time frame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
Hospital Anxiety and Depression Scale (HADS)
Time frame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayley Robinson, MSc principal investigator
University of Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WhatsApp, Pedometer and Step Diary in people with COPD and Physical Activity, run by University of Lincoln at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention (time frame: 55 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.