NCT00962078

Brief Summary

The purpose of this study is to study the effects of a complex pulmonary rehabilitation program on mobility measured by 6 minute walking distance (6MWD) and physical activity, measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL (SF36, EuroQul)), anxiety and depression (HADS)and PaCO2-behavior under physical activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
9 years until next milestone

Results Posted

Study results publicly available

September 23, 2019

Completed
Last Updated

September 23, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

July 27, 2009

Results QC Date

March 6, 2019

Last Update Submit

August 21, 2019

Conditions

COPDPre-Lung-TransplantationHypercapniaRespiratory Insufficiency

Keywords

COPDPre-Lung-TransplantationIntervall versus continuous training6 MWD

Outcome Measures

Primary Outcomes (1)

  • Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)

    value at day 21 minus value at day 1

Secondary Outcomes (1)

  • Dyspnoea During Exercise Measured on the Borg Scale

    mean values from day 1 to day 21

Study Arms (2)

interval training

OTHER

interval training in lung transplant candidates

Other: interval training

Continuous Training

OTHER

continuous training in lung transplant candidates

Other: continuous endurance training

Interventions

continuous endurance trainingOTHER

at 60 percent of peak Watt

Continuous Training
interval trainingOTHER

at 100 percent of peak Watt

interval training

Eligibility Criteria

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

You may qualify if:

  • pre-LTx (listed for lung-transplantation or currently undergoing evaluation)
  • COPD Stadium IV GOLD
  • α-1-Antitrypsin-deficiency-Emphysema
  • respiratory Insufficiency
  • oxygen therapy (LTOT)

You may not qualify if:

  • serious Exacerbation (Symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation
  • clinical signs of manifest heart insufficiency
  • acute coronar syndrome
  • left heart insufficiency(EF \< 40%)
  • missing Compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypercapniaRespiratory Insufficiency

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsRespiration Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Rainer Gloeckl
Organization
Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany
rgloeckl@schoen-klinik.de
+49 8652 931630

Study Officials

  • Klaus Kenn, Dr.med.

    Klinikum Berchtesgadener Land, Schön-Kliniken

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 27, 2009

First Posted

August 19, 2009

Study Start

July 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

September 23, 2019

Results First Posted

September 23, 2019

Record last verified: 2019-08

Locations

DE(1)