Chronic Obstructive Pulmonary DiseaseIMPACTNCT06330623
Developing Personalised Relative Physical Activity Thresholds in COPD.
An observational study of Chronic Obstructive Pulmonary Disease, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The aim of this observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2023to 31 Mar 2026
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Phase 1: Patients from the COPD nursing ward, previous research studies and pulmonary rehabilitation programme. Phase 2: Patients from the pulmonary rehabilitation programme.
Who may be able to join
- Willing and able to provide informed consent for participation in the research.
- The patient has a confirmed diagnosis of COPD using spirometry (based on GOLD criteria (Agustí et al., 2023).
- Male or female, aged 40+ years
- Able to communicate in written and spoken English.
- Willing and able to provide informed consent for participation in the research.
- The patient has a confirmed diagnosis of COPD using spirometry (based on GOLD criteria.
Show all 9Show fewer
- The patient is referred for PR at the UHL.
- Male or female, aged 40+ years
- Able to communicate in written and spoken English
Who cannot join
- Unable to provide valid informed consent.
- Severe psychiatric disorders
- Aged less than 40 years
- Unable to understand written or spoken English.
- Phase 2:
- Unable to provide valid informed consent.
Show all 13Show fewer
- Lack of motivation to participate in PR programme.
- Any-contra-indications absolute or relative to exercise training.
- Has had a cardiac event within last 6 weeks
- Severe psychiatric disorders
- Patients with a history of MRSA +ve screens (patients can be assessed and given an exercise programme but cannot attend the classes. Patients need to have 3 consecutive -ve MRSA swabs before they can attend).
- Aged less than 40 years
- Unable to understand written or spoken English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Leicester Biomedical Research Centre - Respiratory
Leicester, Leicestershire, LE67 2DU
About this study
Official title: Developing Personalised, Relative Intensity Physical Activity Thresholds for Accelerometer-Derived Measures of Physical Activity in COPD (IMPACT)
The aim of this observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity.
The main questions this study aims to answer are:
Read more
- Phase 1: What does physical activity (intensity) mean to people with COPD?
- Phase 2: Are there differences between time spent in absolute and relative physical activity for people with COPD?
Phase 1 Participants will take part in semi-structured interview (30-45 minutes) about living with COPD and perceptions of physical activity and how they perceive intensity. This will also include photovoice and photo-elicitation. Demographic information will be recorded and participants will also complete several respiratory symptom questionnaires.
Phase 2:
Participants will take part in physical activity testing before and after pulmonary rehabilitation while wearing physical activity monitors. Demographic information will be recorded and participants will also complete several respiratory symptom and physical activity questionnaires. Participants will also wear the physical activity monitors for 8 days after the pre-testing sessions and after their final pulmonary rehabilitation class.
Sub-study:
Participants will be asked to take images of barriers during physical activity, facilitators during physical activity, feelings during physical activity and types of physical activity they take part in for 8 days after their final pulmonary rehabilitation class. Participants will then take part in a semi-structured interview about the images their have taken while doing physical activity.
Read the detailed description
Physical activity (PA) helps prevent and manage non-communicable diseases such as chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) has been shown to benefit people living with COPD by reducing breathlessness, increasing muscle strength, and improving the management of exacerbations. However, the improvement in PA in individuals with COPD remains inconsistent following PR. Despite the personalised nature of PA prescription during PR, the evaluation of free-living PA data has been limited to a 'one size fits all' approach using absolute intensity categories. Reduced exercise tolerance can result in PA being perceived at a high intensity relative to a person's exercise capacity, despite the absolute intensity being low. Exploring both the relative and absolute intensity of PA could offer additional insights and clinical relevance for the evaluation of physical activity in COPD populations.
The aim of this research is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity PA in a user-friendly format for PR teams and service users.
Phase 1 objective: To explore what PA means to people with COPD in the context of relative intensity and pulmonary rehabilitation.
Phase 2 objective: To examine the differences between time spent in physical activity intensity expressed in absolute and relative terms for people with COPD.
Phase 1: Semi-structured interviews will take place where participants will discuss their COPD and their perceptions of physical activity and relative intensity. The interviews will be in person (Biomedical research centre, Leicester) or over the phone/video call. The participants will complete several questionnaires about respiratory symptoms. Before taking part in the interviews, participants will also be asked to take pictures, using a camera provided, of when they are doing physical activity. This will be for a 7 day period before the interview.
Phase 2: Participants will take part in exercise testing and complete questionnaires pre and post pulmonary rehabilitation while wearing activity and gait monitors. Participants will also be asked to wear the activity monitors for 8-days after the pre-testing sessions and 8-days after their last pulmonary rehabilitation class. Following their last pulmonary rehabilitation class, 20 participants will be asked to take photographs during the period they are wearing accelerometers and motion sensors. When the participants return the devices, they will take part in an interview to discuss the images they have taken while taking part in physical activity.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Absolute Intensity, Activity Monitors, Chronic Obstructive Pulmonary Disease, Exercise Capacity, Physical Activity, Relative Intensity
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Cohort | These participants will be recruited from: * Previous research studies * COPD nursing ward * Pulmonary rehabilitation | |
| Phase 2 Cohort | These participants will be recruited from the pulmonary rehabilitation service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Semi-structured Interviews
Semi-structured interview with individuals with COPD
Measured: 30-45 minutes
Phase 2 - Differences between time spent in PA intensity expressed in absolute and relative intensity.
Differences between time spent in PA intensity expressed in absolute and relative using activity monitors (wrist and waist) for eight days before and after the PR programme.
Measured: 8 days
Secondary outcomes (12)
Phase 1 - Medical Research Council (MRC) Dyspnoea Scale
Medical Research Council (MRC) Dyspnoea Scale Minimum value: 1 Maximum value: 5 The higher the score, the worse the outcome (breathlessness).
Measured: 2 minutes
Phase 1 - COPD Assessment Test (CAT)
COPD Assessment Test (CAT)
Measured: 5 minutes
Phase 1 - Chronic Respiratory Questionnaire (CRQ-SR)
Chronic Respiratory Questionnaire (CRQ-SR)
Measured: 5 minutes
Phase 1 - Photovoice and photo-elicitation
Photovoice is a qualitative research method that focuses on participants identifying and addressing important topics that matter to them through photography. This will gain greater insight from the participants about their experiences of participating in PA. Participant-generated images will be used to inform the photo-elicitation aspect of the interview to enable participants to capture in real time, more graphically illustrate their experiences and perceptions of different types of PA.
Measured: 7 days
Phase 2 - Medical Research Council (MRC) Dyspnoea Scale
Medical Research Council (MRC) Dyspnoea Scale
Measured: 2 minutes
Phase 2 - COPD Assessment Test (CAT)
COPD Assessment Test (CAT)
Measured: 5 minutes
Phase 2 - Chronic Respiratory Questionnaire (CRQ-SR)
Chronic Respiratory Questionnaire (CRQ-SR)
Measured: 5 minutes
Phase 2 - Gait Analysis
Gait Analysis - Speed, Variability, Asymmetry
Measured: 45 minutes
Phase 2 - Exercise Capacity (ISWT)
Incremental Shuttle Walk Test
Measured: 30-45 minutes
Phase 2 - Exercise Capacity (ESWT)
Endurance Shuttle Walk Test
Measured: 15-30 minutes
Phase 2 - Clinical PROactive Physical Activity instrument in COPD (C-PPAC)
Clinical PROactive Physical Activity instrument in COPD (C-PPAC)
Measured: 5 minutes
Phase 2 - Photovoice and photo-elicitation
Photovoice is a qualitative research method that focuses on participants identifying and addressing important topics that matter to them through photography. This will gain greater insight from the participants about their experiences of participating in PA. Participant-generated images will be used to inform the photo-elicitation aspect of the interview to enable participants to capture in real time, more graphically illustrate their experiences and perceptions of different types of PA.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start22 Nov 2023
- Primary completion28 Oct 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- University of Leicester University of Leicester, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330623
- Sponsor's protocol ID
- 0929
- Other IDs
- 321985
- Acronym
- IMPACT
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will only be available in publications.
Publications
Lloyd-Evans PHI, Malcolm D, Singh SJ, Rowlands AV, Chaplin E, Ward S, Orme MW. Intensity is in the eye of the beholder: a qualitative photovoice study of perceptions of physical activity intensity for people with chronic obstructive pulmonary disease. BMC Pulm Med. 2026 Jul 21. doi: 10.1186/s12890-026-04520-8. Online ahead of print.
PubMed 42482213
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Personalised, Relative Intensity Physical Activity Thresholds for Accelerometer-Derived Measures of Physical Activity in COPD (IMPACT)
- ClinicalTrials.gov ID
- NCT06330623
- Acronym / sponsor ID
- IMPACT / 0929
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Absolute Intensity, Activity Monitors, Chronic Obstructive Pulmonary Disease, Exercise Capacity, Physical Activity, Relative Intensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 26 Mar 2024 (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 observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity.
The main questions this study aims to answer are:
- Phase 1: What does physical activity (intensity) mean to people with COPD?
- Phase 2: Are there differences between time spent in absolute and relative physical activity for people with COPD?
Phase 1 Participants will take part in semi-structured interview (30-45 minutes) about living with COPD and perceptions of physical activity and how they perceive intensity. This will also include photovoice and photo-elicitation. Demographic information will be recorded and participants will also complete several respiratory symptom questionnaires.
Phase 2:
Participants will take part in physical activity testing before and after pulmonary rehabilitation while wearing physical activity monitors. Demographic information will be recorded and participants will also complete several respiratory symptom and physical activity questionnaires. Participants will also wear the physical activity monitors for 8 days after the pre-testing sessions and after their final pulmonary rehabilitation class.
Sub-study:
Participants will be asked to take images of barriers during physical activity, facilitators during physical activity, feelings during physical activity and types of physical activity they take part in for 8 days after their final pulmonary rehabilitation class. Participants will then take part in a semi-structured interview about the images their have taken while doing physical activity.
Detailed description
Physical activity (PA) helps prevent and manage non-communicable diseases such as chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) has been shown to benefit people living with COPD by reducing breathlessness, increasing muscle strength, and improving the management of exacerbations. However, the improvement in PA in individuals with COPD remains inconsistent following PR. Despite the personalised nature of PA prescription during PR, the evaluation of free-living PA data has been limited to a 'one size fits all' approach using absolute intensity categories. Reduced exercise tolerance can result in PA being perceived at a high intensity relative to a person's exercise capacity, despite the absolute intensity being low. Exploring both the relative and absolute intensity of PA could offer additional insights and clinical relevance for the evaluation of physical activity in COPD populations.
The aim of this research is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity PA in a user-friendly format for PR teams and service users.
Phase 1 objective: To explore what PA means to people with COPD in the context of relative intensity and pulmonary rehabilitation.
Phase 2 objective: To examine the differences between time spent in physical activity intensity expressed in absolute and relative terms for people with COPD.
Phase 1: Semi-structured interviews will take place where participants will discuss their COPD and their perceptions of physical activity and relative intensity. The interviews will be in person (Biomedical research centre, Leicester) or over the phone/video call. The participants will complete several questionnaires about respiratory symptoms. Before taking part in the interviews, participants will also be asked to take pictures, using a camera provided, of when they are doing physical activity. This will be for a 7 day period before the interview.
Phase 2: Participants will take part in exercise testing and complete questionnaires pre and post pulmonary rehabilitation while wearing activity and gait monitors. Participants will also be asked to wear the activity monitors for 8-days after the pre-testing sessions and 8-days after their last pulmonary rehabilitation class. Following their last pulmonary rehabilitation class, 20 participants will be asked to take photographs during the period they are wearing accelerometers and motion sensors. When the participants return the devices, they will take part in an interview to discuss the images they have taken while taking part in physical activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Cohort | – | –These participants will be recruited from: * Previous research studies * COPD nursing ward * Pulmonary rehabilitation |
| Phase 2 Cohort | – | –These participants will be recruited from the pulmonary rehabilitation service. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Phase 1: Patients from the COPD nursing ward, previous research studies and pulmonary rehabilitation programme. Phase 2: Patients from the pulmonary rehabilitation programme.
Key inclusion criteria (9 listed)
- Willing and able to provide informed consent for participation in the research.
- The patient has a confirmed diagnosis of COPD using spirometry (based on GOLD criteria (Agustí et al., 2023).
- Male or female, aged 40+ years
- Able to communicate in written and spoken English.
- Willing and able to provide informed consent for participation in the research.
Key exclusion criteria (13 listed)
- Unable to provide valid informed consent.
- Severe psychiatric disorders
- Aged less than 40 years
- Unable to understand written or spoken English.
- Unable to provide valid informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phase 1 - Semi-structured Interviews
Time frame: 30-45 minutes
Semi-structured interview with individuals with COPD
Phase 2 - Differences between time spent in PA intensity expressed in absolute and relative intensity.
Time frame: 8 days
Differences between time spent in PA intensity expressed in absolute and relative using activity monitors (wrist and waist) for eight days before and after the PR programme.
12 secondary outcomes
Phase 1 - Medical Research Council (MRC) Dyspnoea Scale
Time frame: 2 minutes
Phase 1 - COPD Assessment Test (CAT)
Time frame: 5 minutes
Phase 1 - Chronic Respiratory Questionnaire (CRQ-SR)
Time frame: 5 minutes
Phase 1 - Photovoice and photo-elicitation
Time frame: 7 days
Phase 2 - Medical Research Council (MRC) Dyspnoea Scale
Time frame: 2 minutes
Phase 2 - COPD Assessment Test (CAT)
Time frame: 5 minutes
Phase 2 - Chronic Respiratory Questionnaire (CRQ-SR)
Time frame: 5 minutes
Phase 2 - Gait Analysis
Time frame: 45 minutes
Phase 2 - Exercise Capacity (ISWT)
Time frame: 30-45 minutes
Phase 2 - Exercise Capacity (ESWT)
Time frame: 15-30 minutes
Phase 2 - Clinical PROactive Physical Activity instrument in COPD (C-PPAC)
Time frame: 5 minutes
Phase 2 - Photovoice and photo-elicitation
Time frame: 8 days
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 19 May 2026.
- Derived from this study: PubMed 42482213Lloyd-Evans PHI, Malcolm D, Singh SJ, Rowlands AV, Chaplin E, Ward S, Orme MW. Intensity is in the eye of the beholder: a qualitative photovoice study of perceptions of physical activity intensity for people with chronic obstructive pulmonary disease. BMC Pulm Med. 2026 Jul 21. doi: 10.1186/s12890-026-04520-8. Online ahead of print.
- Individual participant dataSharing planned: No. The data will only be available in publications.
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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.
University of Leicester University of Leicester principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University of Leicester 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 9 inclusion and 13 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 19 May 2026. 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?
Phase 1 - Semi-structured Interviews (time frame: 30-45 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330623, which also lists 1 linked publication.
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 19 May 2026.