NCT03477526

Brief Summary

As the result of our last study "Long Term effects of an Inpatient Pulmonary Program in Patients with Pulmonary Fibrosis" already demonstrated the positive effects of a Pulmonary Rehabiliation on the mental status. In this current study the aim will be to analyse the personality type regarding anxiety and depression

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1 day

First QC Date

March 19, 2018

Last Update Submit

November 10, 2020

Conditions

Keywords

pulmonary fibrosisCOPDpulmonary rehabilitationmental status (anxiety and depression)quality of lifephysical activity

Outcome Measures

Primary Outcomes (1)

  • Anxiety score

    Hospital Anxiety and Depression scale

    3 weeks

Secondary Outcomes (1)

  • Anxiety score

    3 months

Study Arms (2)

COPD patients (GOLD stage III-IV)

EXPERIMENTAL
Procedure: Pulmonary rehabilitation program

IPF patients

ACTIVE COMPARATOR
Procedure: Pulmonary rehabilitation program

Interventions

3 weeks, ...

COPD patients (GOLD stage III-IV)IPF patients

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD GOLD III-IV
  • IPF according Pulmonary Guidelines

You may not qualify if:

  • \< 30% FVC comorbidities with a negativ influence on the prognosis neurological and orthopaedic deficits, which make the participation of the pulmonary rehabilitation impossible non-compliance no written informed consent of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisPulmonary Disease, Chronic ObstructivePulmonary FibrosisAnxiety DisordersDepressionMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosisMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 26, 2018

Study Start

February 26, 2019

Primary Completion

February 27, 2019

Study Completion

February 27, 2019

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations