Trial Outcomes & Findings for Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection (NCT NCT01963923)
NCT ID: NCT01963923
Last Updated: 2020-05-01
Results Overview
Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three weeks after hospital discharge in comparison with the control group.
COMPLETED
NA
40 participants
Exercise tolerance 3 weeks after hospital discharge
2020-05-01
Participant Flow
During the study period, 40 patients were recruited (20 per arm) but only 12 patients in the control group and 10 patients in the rehabilitation group were included in the analysis due to losses in follow-up
Participant milestones
| Measure |
Control Group
|
Rehabilitation Group
|
|---|---|---|
|
3 Weeks Post-surgery
STARTED
|
20
|
20
|
|
3 Weeks Post-surgery
COMPLETED
|
12
|
10
|
|
3 Weeks Post-surgery
NOT COMPLETED
|
8
|
10
|
|
3 Months Post-surgery
STARTED
|
12
|
10
|
|
3 Months Post-surgery
COMPLETED
|
10
|
9
|
|
3 Months Post-surgery
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection
Baseline characteristics by cohort
| Measure |
Control Group
n=12 Participants
|
Rehabilitation Group
n=10 Participants
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
70.9 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Exercise tolerance 3 weeks after hospital dischargeMaximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three weeks after hospital discharge in comparison with the control group.
Outcome measures
| Measure |
Rehabilitation Group
n=10 Participants
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
|
Control Group
n=12 Participants
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|---|---|---|
|
Exercise Tolerance
|
459.7 Seconds
Standard Deviation 264.7
|
341 Seconds
Standard Deviation 216.3
|
PRIMARY outcome
Timeframe: Exercise tolerance 3 months after surgeryMaximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three months after hospital discharge in comparison with the control group.
Outcome measures
| Measure |
Rehabilitation Group
n=9 Participants
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
|
Control Group
n=10 Participants
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|---|---|---|
|
Exercise Tolerance
|
560.3 Seconds
Standard Deviation 273.3
|
271.5 Seconds
Standard Deviation 95
|
SECONDARY outcome
Timeframe: Quality of life 3 weeks after surgeryHealth-Related Quality of Life measured with the 36-Item Short-Form Health Survey Version 2 (SF-36) three weeks post-surgery. This scale is scored on a 0 - 100 scale, with higher scores referring to a better health-related quality of life. The scale compromises 8 subscales and two summaries (physial and mental).
Outcome measures
| Measure |
Rehabilitation Group
n=10 Participants
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
|
Control Group
n=12 Participants
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|---|---|---|
|
Health-Related Quality of Life
|
38 units on a scale
Standard Deviation 8.6
|
42.1 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Quality of life post-surgeryHealth-Related Quality of Life measured with the 36-Item Short-Form Health Survey Version 2 (SF-36) three months post-surgery. This scale is scored on a 0 - 100 scale, with higher scores referring to a better health-related quality of life. The scale compromises 8 subscales and two summaries (physial and mental).
Outcome measures
| Measure |
Rehabilitation Group
n=9 Participants
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
|
Control Group
n=10 Participants
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|---|---|---|
|
Health-Related Quality of Life
|
45.8 units on a scale
Standard Deviation 5.8
|
44.7 units on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 3 weeks post-surgeryUpper body strength measured with the Arm-Curl Test of the Senior Fitness Test. The test measures the number of curl-arm movements with a 2.27kg or a 3.61 kg dumbbell for women and men respectively during 30 seconds.
Outcome measures
| Measure |
Rehabilitation Group
n=10 Participants
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
|
Control Group
n=10 Participants
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|---|---|---|
|
Upper Body Strength
|
17 Repetitions
Standard Deviation 3.4
|
17 Repetitions
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 3 months post-surgeryUpper body strength measured with the Arm-Curl Test of the Senior Fitness Test. The test measures the number of curl-arm movements with a 2.27kg or a 3.61 kg dumbbell for women and men respectively during 30 seconds.
Outcome measures
| Measure |
Rehabilitation Group
n=10 Participants
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
|
Control Group
n=9 Participants
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|---|---|---|
|
Upper Body Strength
|
16.1 Repetitions
Standard Deviation 3.1
|
16 Repetitions
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 3 weeks post-surgeryLower body strength measured with the sit-to-stand Test. The test consist of counting the number of full stands from a chair that can be completed in 30 seconds with arms folded across chest.
Outcome measures
| Measure |
Rehabilitation Group
n=10 Participants
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
|
Control Group
n=10 Participants
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|---|---|---|
|
Lower Body Strength
|
13.2 Repetitions
Standard Deviation 5.86
|
12.2 Repetitions
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: 3 months post-surgeryLower body strength measured with the sit-to-stand Test. The test consist of counting the number of full stands from a chair that can be completed in 30 seconds with arms folded across chest.
Outcome measures
| Measure |
Rehabilitation Group
n=10 Participants
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Pulmonary Rehabilitation Program: The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
|
Control Group
n=9 Participants
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|---|---|---|
|
Lower Body Strength
|
11.5 Repetitions
Standard Deviation 2.55
|
14.9 Repetitions
Standard Deviation 5.6
|
Adverse Events
Rehabilitation Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Esther Gimenez Moolhuyzen
Complejo Hospitalario Universitario A Coruña
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place