Clinical trial NCT02802618: Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD
Official title: Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Validity
Reliability
Rehabilitation
Translation
Education
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: The Swedish Heart and Lung Association
name: Landstingens Ömsesidiga Försäkringsbolag (Löf)
name: Flemingsberg Science
name: The Mats Kleberg Foundation
First posted: 2016-06-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
* Stadium II-IV of COPD
* Must be able to comprehend the Swedish language

Exclusion Criteria:

* Not diagnosed with COPD
* Does not understand written and verbal Swedish

Primary outcomes:
measure: Improved health related quality of life
timeFrame: Change from Baseline health related quality of life at 10 weeks
Secondary outcomes:
measure: Improved health related quality of life
timeFrame: Change from Baseline health related quality of life at 10 weeks
measure: Improved health related quality of life
timeFrame: Change from Baseline health related quality of life at 2 and 10 weeks
measure: Improved exercise self efficacy
timeFrame: Change from Baseline exercise self efficacy at 10 weeks
measure: Improved physical performance
timeFrame: Change from Baseline physical performance at 10 weeks
measure: Improved physical performance
timeFrame: Change from Baseline physical performance at 10 weeks
measure: Attendance to rehabilitation programme
timeFrame: 10 weeks
measure: Improved knowledge of content in rehabilitation programme
timeFrame: Change from Baseline knowledge of content in rehabilitation programme at 6 months
measure: Compliance to treatment
timeFrame: 6 months
measure: Compliance to physical activity
timeFrame: 6 months
measure: Visits to hospital, primary care
timeFrame: 6 months
measure: Motivation with rehabilitation programme
timeFrame: 6 months
measure: Stimulation with the of rehabilitation programme
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of physiotherapy, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Ulrika Einarsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.