NCT04257630

Brief Summary

The aim of this prospective observational trial is to evaluate the influence of Coping strategies on pulmonary rehabilitation outcomes like 6-minute walk distance and Quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

4.9 years

First QC Date

January 28, 2020

Last Update Submit

April 28, 2025

Conditions

Idiopathic Pulmonary FibrosisChronic Obstructive Pulmonary Disease

Keywords

coping strategiespsychological burdenanxietydepressionquality of lifepulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Coping strategies in anxious vs. non-anxious IPF-patients

    Difference in Essener Coping questionnaire in axious (Hospital anxiety and Depression scale \[HADS\]\>=8points) and non-anxious (HADS\<8points) IPF-patients

    Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21)

Secondary Outcomes (18)

  • Correlation between 6-minute walk distance and Essener Coping questionnaire

    Day 1 and Day 21

  • Correlation between Health related Quality of life and Essener Coping questionnaire

    Day 1, Day 21 and 3-months after pulmonary rehabilitation program

  • Correlation between 6-minute walk distance and Hospital Anxiety and Depresion scale

    Day 1 and Day 21

  • Correlation between 6-minute walk distance and COPD anxiety questionnaire

    Day 1 and Day 21

  • Correlation between 6-minute walk distance and Illness Perception Questionnaire

    Day 1 and Day 21

  • +13 more secondary outcomes

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who take part in a pulmonary rehabilitation program at Schoen Klinik Berchtesgadener land will recruited.

You may qualify if:

  • Patients with idiopathic pulmonary fibrosis with a FVC between 30 to 70% predicted or
  • Patients with chronic obstructive pulmonary disease (GOLD stage III and IV)
  • Age: 50-80 years
  • Medical treatment according to recent guidelines (including long-term oxygen therapy and or non invasive ventilation)
  • Written informed consent

You may not qualify if:

  • Non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schoen Klinik BGL

Schoenau Am Königssee, Bavaria, 83471, Germany

Location

Related Publications (2)

  • Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

    PMID: 24127811BACKGROUND

  • Hallas CN, Howard C, Theadom A, Wray J. Negative beliefs about breathlessness increases panic for patients with chronic respiratory disease. Psychol Health Med. 2012;17(4):467-77. doi: 10.1080/13548506.2011.626434. Epub 2012 Feb 13.

    PMID: 22329594BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisPulmonary Disease, Chronic ObstructiveAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor for pulmonary rehabilitation

Study Record Dates

First Submitted

January 28, 2020

First Posted

February 6, 2020

Study Start

February 6, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations

DE(1)