NCT02802618

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

11.7 years

First QC Date

May 27, 2016

Last Update Submit

March 4, 2025

Conditions

Keywords

ValidityReliabilityRehabilitationTranslationEducation

Outcome Measures

Primary Outcomes (1)

  • Improved health related quality of life

    COPD Assessment Test

    Change from Baseline health related quality of life at 10 weeks

Secondary Outcomes (12)

  • Improved health related quality of life

    Change from Baseline health related quality of life at 10 weeks

  • Improved health related quality of life

    Change from Baseline health related quality of life at 2 and 10 weeks

  • Improved exercise self efficacy

    Change from Baseline exercise self efficacy at 10 weeks

  • Improved physical performance

    Change from Baseline physical performance at 10 weeks

  • Improved physical performance

    Change from Baseline physical performance at 10 weeks

  • +7 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

The pulmonary rehabilitation consists of exercise training during two times/week for 10 weeks and a theoretic part presented with 3D visualization technique.

Interactive 3D visualization technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of physiotherapy, Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ulrika Einarsson, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 16, 2016

Study Start

October 1, 2013

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations