COPD, Hypercapnia, Pre-Lung-Transplantation, Respiratory Insufficiency
Conditions
Keywords
COPD, Pre-Lung-Transplantation, Intervall versus continuous training, 6 MWD
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.
Interventions
at 60 percent of peak Watt
OTHERinterval training
at 100 percent of peak Watt
Sponsors
Schön Klinik Berchtesgadener Land
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD) | value at day 21 minus value at day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnoea During Exercise Measured on the Borg Scale | mean values from day 1 to day 21 | 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interval Training interval training in lung transplant candidates
interval training: at 100 percent of peak Watt | 35 |
| Continuous Training continuous training in lung transplant candidates
continuous endurance training: at 60 percent of peak Watt | 36 |
| Total | 71 |
Baseline characteristics
| Characteristic | Interval Training | Continuous Training | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 6 | 55 years STANDARD_DEVIATION 7 | 54 years STANDARD_DEVIATION 7 |
| FEV1% | 24 % predicted STANDARD_DEVIATION 8 | 27 % predicted STANDARD_DEVIATION 7 | 25 % predicted STANDARD_DEVIATION 8 |
| Region of Enrollment Germany | 36 participants | 35 participants | 71 participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 |
Outcome results
Primary
Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
Time frame: value at day 21 minus value at day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interval Training | Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD) | 35 meter | Standard Deviation 29 |
| Continuous Training | Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD) | 36 meter | Standard Deviation 42 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interval Training | Dyspnoea During Exercise Measured on the Borg Scale | 6.2 units on a scale | Standard Deviation 1.6 |
| Continuous Training | Dyspnoea During Exercise Measured on the Borg Scale | 7.2 units on a scale | Standard Deviation 1.4 |