Trial Outcomes & Findings for Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx) (NCT NCT00962078)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

71 participants

Primary outcome timeframe

value at day 21 minus value at day 1

Results posted on

2019-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Interval Training interval training in lung transplant candidates interval training: at 100 percent of peak Watt	Continuous Training continuous training in lung transplant candidates continuous endurance training: at 60 percent of peak Watt
Overall Study STARTED	35	36
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interval Training n=35 Participants interval training in lung transplant candidates interval training: at 100 percent of peak Watt	Continuous Training n=36 Participants continuous training in lung transplant candidates continuous endurance training: at 60 percent of peak Watt	Total n=71 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 6 • n=5 Participants	55 years STANDARD_DEVIATION 7 • n=7 Participants	54 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment Germany	36 participants n=5 Participants	35 participants n=7 Participants	71 participants n=5 Participants
FEV1%	24 % predicted STANDARD_DEVIATION 8 • n=5 Participants	27 % predicted STANDARD_DEVIATION 7 • n=7 Participants	25 % predicted STANDARD_DEVIATION 8 • n=5 Participants

PRIMARY outcome

Timeframe: value at day 21 minus value at day 1

Outcome measures

Outcome measures
Measure	Interval Training n=30 Participants interval training in lung transplant candidates interval training: at 100 percent of peak Watt	Continuous Training n=30 Participants continuous training in lung transplant candidates continuous endurance training: at 60 percent of peak Watt
Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)	35 meter Standard Deviation 29	36 meter Standard Deviation 42

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Interval Training n=30 Participants interval training in lung transplant candidates interval training: at 100 percent of peak Watt	Continuous Training n=30 Participants continuous training in lung transplant candidates continuous endurance training: at 60 percent of peak Watt
Dyspnoea During Exercise Measured on the Borg Scale	6.2 units on a scale Standard Deviation 1.6	7.2 units on a scale Standard Deviation 1.4

Adverse Events

Interval Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuous Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rainer Gloeckl

Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany

Phone: +49 8652 931630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place