Chronic Obstructive Pulmonary DiseaseNCT02802618
Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD
A study testing Interactive 3D visualization technique in people with Chronic Obstructive Pulmonary Disease, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Interactive 3D visualization technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
- Stadium II-IV of COPD
- Must be able to comprehend the Swedish language
Who cannot join
- Not diagnosed with COPD
- Does not understand written and verbal Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of physiotherapy, Karolinska University Hospital
Stockholm, 14186
About this study
Official title: Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in Chronic Obstructive Pulmonary Disease (COPD)
A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL
The purpose of this study was therefore to develop a pulmonary educational program in interactive 3D visualization technology and to evaluate differences between education with 3D technique or conventional technique in patient with COPD.
Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is one of the major health scourges. In 2002 COPD was the fifth leading cause of death and estimates show that COPD becomes in 2030 the third leading cause of death worldwide. The dominant cause of COPD is tobacco smoking. COPD now affects men and women almost equally. The most common symptoms of COPD are breathlessness, excessive sputum production, and a chronic cough which causes decrease in health related quality of life (HRQL). Dyspnea and movement limitations are also common symptoms in patients with COPD and this often leads to reduced levels of physical activity, physical capacity and HRQL. The Leicester Cough Questionnaire (LCQ) is a valid evaluation tool for HRQL in patients with chronic cough. Currently no specific cough questionnaire exists in Swedish.
Pulmonary rehabilitation including education and exercise training improves health. The Physiotherapy department has conducted rehabilitation programs for patients with COPD since 1995. The COPD-program has several times been updated according to existing evidence.
Education in anatomy, physiology, physical therapy and self-training is a big part of the physical therapist's workday. The education imparts complex knowledge. It is demanding to mediate this as education is expected to raise the patient's desire to understand, create opportunities to understand and leave a lasting impression. In effective learning repetition, own search for information, stimulation, emotional impact and experience are important factors. Information technology is developing rapidly and patient's use of this technology is increasing. It is therefore essential that education is adapted to new requirements. Interactive 3 dimensional (3D) visualization techniques can be used to represent the human body. Interactive 3D technique used in patient education has not yet been studied.
A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL
In the current study it will be investigated whether och not there are differences between pulmonary educational program in interactive 3D visualization technology and in conventional technique in patients with COPD.
Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Interactive 3D visualization technique
- Keywords
- Validity, Reliability, Rehabilitation, Translation, Education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive 3D visualization techniqueOther
The pulmonary rehabilitation consists of exercise training during two times/week for 10 weeks and a theoretic part presented with 3D visualization technique.
| Study group | Role | What they receive |
|---|---|---|
| Interactive 3D visualization technique | Experimental | The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with 3D technique.
Patients randomized into education by 3D technique. Receives: Other: Interactive 3D visualization technique |
| Conventional technique | No intervention | The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with conventional technique. Patients randomized into education by conventional technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved health related quality of life
COPD Assessment Test
Measured: Change from Baseline health related quality of life at 10 weeks
Secondary outcomes (12)
Improved health related quality of life
S:t George´s Respiratory Questionnaire
Measured: Change from Baseline health related quality of life at 10 weeks
Improved health related quality of life
Leicester Cough Questionnaire
Measured: Change from Baseline health related quality of life at 2 and 10 weeks
Improved exercise self efficacy
SCI Exercise Self Efficacy Scale (SCI=Spinal Cord Injury)
Measured: Change from Baseline exercise self efficacy at 10 weeks
Improved physical performance
JAMAR Hydraulic Hand Dynamometer
Measured: Change from Baseline physical performance at 10 weeks
Improved physical performance
6 minute walk test
Measured: Change from Baseline physical performance at 10 weeks
Attendance to rehabilitation programme
Attendance record
Measured: 10 weeks
Improved knowledge of content in rehabilitation programme
Questionaire
Measured: Change from Baseline knowledge of content in rehabilitation programme at 6 months
Compliance to treatment
Single question about compliance to treatment
Measured: 6 months
Compliance to physical activity
Single question about compliance to physical activity
Measured: 6 months
Visits to hospital, primary care
Single question about number of visits to hospital and primary care
Measured: 6 months
Motivation with rehabilitation programme
Visual analog scale, focus group interview
Measured: 6 months
Stimulation with the of rehabilitation programme
Visual analog scale, focus group interview
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startOct 2013
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Heart and Lung Association, Landstingens Ömsesidiga Försäkringsbolag (Löf), Flemingsberg Science, The Mats Kleberg Foundation
- Responsible party
- Principal investigator, Ulrika Einarsson, Karolinska University Hospital
- Investigators
- Ulrika Einarsson, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802618
- Sponsor's protocol ID
- 2013/1276-31/3
- Status last verified
- Mar 2025
- First submitted
- 27 May 2016
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sonnerfors P, Nordlin AK, Nykvist M, Thunstrom U, Einarsson U. Interactive 3D visualisation technique used in pulmonary rehabilitation in chronic obstructive pulmonary disease: A randomised controlled study evaluating quality of life, compliance and use of health care. Digit Health. 2025 Jan 17;11:20552076241308940. doi: 10.1177/20552076241308940. eCollection 2025 Jan-Dec.
PubMed 39830146
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02802618
- Acronym / sponsor ID
- 2013/1276-31/3
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Validity, Reliability, Rehabilitation, Translation, Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- The Swedish Heart and Lung Association, Landstingens Ömsesidiga Försäkringsbolag (Löf), Flemingsberg Science, The Mats Kleberg Foundation
- Study start
- Oct 2013
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- 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.
A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL
The purpose of this study was therefore to develop a pulmonary educational program in interactive 3D visualization technology and to evaluate differences between education with 3D technique or conventional technique in patient with COPD.
Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability.
Detailed description
Chronic obstructive pulmonary disease (COPD) is one of the major health scourges. In 2002 COPD was the fifth leading cause of death and estimates show that COPD becomes in 2030 the third leading cause of death worldwide. The dominant cause of COPD is tobacco smoking. COPD now affects men and women almost equally. The most common symptoms of COPD are breathlessness, excessive sputum production, and a chronic cough which causes decrease in health related quality of life (HRQL). Dyspnea and movement limitations are also common symptoms in patients with COPD and this often leads to reduced levels of physical activity, physical capacity and HRQL. The Leicester Cough Questionnaire (LCQ) is a valid evaluation tool for HRQL in patients with chronic cough. Currently no specific cough questionnaire exists in Swedish.
Pulmonary rehabilitation including education and exercise training improves health. The Physiotherapy department has conducted rehabilitation programs for patients with COPD since 1995. The COPD-program has several times been updated according to existing evidence.
Education in anatomy, physiology, physical therapy and self-training is a big part of the physical therapist's workday. The education imparts complex knowledge. It is demanding to mediate this as education is expected to raise the patient's desire to understand, create opportunities to understand and leave a lasting impression. In effective learning repetition, own search for information, stimulation, emotional impact and experience are important factors. Information technology is developing rapidly and patient's use of this technology is increasing. It is therefore essential that education is adapted to new requirements. Interactive 3 dimensional (3D) visualization techniques can be used to represent the human body. Interactive 3D technique used in patient education has not yet been studied.
A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL
In the current study it will be investigated whether och not there are differences between pulmonary educational program in interactive 3D visualization technology and in conventional technique in patients with COPD.
Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive 3D visualization technique | Experimental | Other: Interactive 3D visualization techniqueThe pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with 3D technique. Patients randomized into education by 3D technique. |
| Conventional technique | No intervention | –The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with conventional technique. Patients randomized into education by conventional technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
- Stadium II-IV of COPD
- Must be able to comprehend the Swedish language
Key exclusion criteria (2 listed)
- Not diagnosed with COPD
- Does not understand written and verbal Swedish
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 |
|---|---|---|
| Interactive 3D visualization techniqueThe pulmonary rehabilitation consists of exercise training during two times/week for 10 weeks and a theoretic part presented with 3D visualization technique. | Other | Interactive 3D visualization technique |
Primary outcome
Improved health related quality of life
Time frame: Change from Baseline health related quality of life at 10 weeks
COPD Assessment Test
12 secondary outcomes
Improved health related quality of life
Time frame: Change from Baseline health related quality of life at 10 weeks
Improved health related quality of life
Time frame: Change from Baseline health related quality of life at 2 and 10 weeks
Improved exercise self efficacy
Time frame: Change from Baseline exercise self efficacy at 10 weeks
Improved physical performance
Time frame: Change from Baseline physical performance at 10 weeks
Improved physical performance
Time frame: Change from Baseline physical performance at 10 weeks
Attendance to rehabilitation programme
Time frame: 10 weeks
Improved knowledge of content in rehabilitation programme
Time frame: Change from Baseline knowledge of content in rehabilitation programme at 6 months
Compliance to treatment
Time frame: 6 months
Compliance to physical activity
Time frame: 6 months
Visits to hospital, primary care
Time frame: 6 months
Motivation with rehabilitation programme
Time frame: 6 months
Stimulation with the of rehabilitation programme
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Results publication: PubMed 39830146Sonnerfors P, Nordlin AK, Nykvist M, Thunstrom U, Einarsson U. Interactive 3D visualisation technique used in pulmonary rehabilitation in chronic obstructive pulmonary disease: A randomised controlled study evaluating quality of life, compliance and use of health care. Digit Health. 2025 Jan 17;11:20552076241308940. doi: 10.1177/20552076241308940. eCollection 2025 Jan-Dec.
- 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.
Ulrika Einarsson, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive 3D visualization technique in people with Chronic Obstructive Pulmonary Disease, run by Karolinska University Hospital at 1 site in Sweden.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Improved health related quality of life (time frame: Change from Baseline health related quality of life at 10 weeks). 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 NCT02802618, 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 6 Mar 2025.