CompletedNCT00962078Updated Sep 23, 2019Results posted

Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

An interventional study of continuous endurance training and interval training in COPD, Pre-Lung-Transplantation and Hypercapnia, sponsored by Schön Klinik Berchtesgadener Land. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-23.

Sponsored by Schön Klinik Berchtesgadener Land · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year after the study started (first participant enrolled Jul 2008, registered Jul 2009).

Phase: Not applicable
Study type: Interventional
Enrollment: 71
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

COPD
Pre-Lung-Transplantation
Hypercapnia
Respiratory Insufficiency

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Keywords

COPD
Pre-Lung-Transplantation
Intervall versus continuous training
6 MWD

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 71 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Schön Klinik Berchtesgadener Land is the lead sponsor of 51 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 71 participants (actual)

Study arms

Other
interval training
interval training in lung transplant candidates
Other: interval training
Other
Continuous Training
continuous training in lung transplant candidates
Other: continuous endurance training

Interventions

Othercontinuous endurance training
at 60 percent of peak Watt
Otherinterval training
at 100 percent of peak Watt

What researchers measure

Primary outcomes

Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
Time frame: value at day 21 minus value at day 1

Secondary outcomes

Dyspnoea During Exercise Measured on the Borg Scale
The Borg scale is a numeric scale that ranges from 0 to 10 points to rate dyspnea. The scale is like follows: 0 Nothing at all 1. Very slight 2. Slight 3. Moderate 4. Somewhat severe 5. Severe 7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal
Time frame: mean values from day 1 to day 21

Results

Posted Sep 23, 2019

Participant flow

Participant flow — Overall Study
Milestone	Interval Training	Continuous Training
Started	35	36
Completed	30	30
Not completed	5	6

Outcome measures

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

Time frame:: value at day 21 minus value at day 1
Reported as:: Mean · meter

Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
meter	Interval Training	Continuous Training
Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)	35 ± 29	36 ± 42

SecondaryDyspnoea During Exercise Measured on the Borg Scale

The Borg scale is a numeric scale that ranges from 0 to 10 points to rate dyspnea. The scale is like follows: 0 Nothing at all 1. Very slight 2. Slight 3. Moderate 4. Somewhat severe 5. Severe 7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal

Time frame:: mean values from day 1 to day 21
Reported as:: Mean · units on a scale

Dyspnoea During Exercise Measured on the Borg Scale
units on a scale	Interval Training	Continuous Training
Dyspnoea During Exercise Measured on the Borg Scale	6.2 ± 1.6	7.2 ± 1.4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Interval Training	—	0/35 (0%)	0/35 (0%)
Continuous Training	—	0/36 (0%)	0/36 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Interval Training	Continuous Training	Total
Mean	52 ± 6	55 ± 7	54 ± 7

Sex: Female, Male
Sex: Female, Male(Participants)	Interval Training	Continuous Training	Total
Female	18	20	38
Male	17	16	33

Region of Enrollment
Region of Enrollment(participants)	Interval Training	Continuous Training	Total
Germany	36	35	71

FEV1%
FEV1%(% predicted)	Interval Training	Continuous Training	Total
Mean	24 ± 8	27 ± 7	25 ± 8

Study locations

1 site

Klinikum Berchtesgadener Land
Schönau am Königssee, 83471, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00962078
Lead sponsor: Schön Klinik Berchtesgadener Land
Responsible party: Klaus Kenn (Dr, Schön Klinik Berchtesgadener Land) — Principal investigator
First posted: Aug 19, 2009
Start date: Jul 2008
Primary completion: Oct 2010
Completion: Oct 2010
Results posted: Sep 23, 2019
Last update: Sep 23, 2019

Study contacts

Klaus Kenn, Dr.med.

study director · Klinikum Berchtesgadener Land, Schön-Kliniken

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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