To quantify the effectiveness of one- legged exercise training in improving functional status of patients with COPD in comparison to two- legged exercise training during a 10 week pulmonary rehabilitation programme.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome variable in the study is: time trial endurance performance test
(sec).
Secondary outcome
Other parameters that will be measured at rest are: FEV1 (L/sec), FVC (L),
Quality of life (questionnaire), ADL (questionnaire).
Parameters that will be measured during maximal exercise are Peak VE (L/min),
Peak VO2 (L/min), Peak CO2 output (L/min), SaO2 (%) HR (beats/min), dyspnea
(visual analog scale), f (breaths/min), peak power (W), energy expenditure
(Joules).
PAEE will be measured during 7 days of free living by combined sensing of
acceleration and heart rate with Actiheart-monitors.
Background summary
Improving exercise capacity is an important part of pulmonary rehabilitation
programmes in patients with chronic obstructive pulmonary disease (COPD).
Most patients with COPD are so limited by shortness of breath (dyspnea), even
at modest levels of ventilation, that their training is restricted to low
intensity training. As a result, COPD patients find it difficult to improve
exercise capacity by low intensity exercise training. One- legged exercise
training might allow training at a relatively higher intensity at a lower
ventilatory load. Therefore, one- legged exercise training might improve
exercise capacity more significantly than two- legged exercise training in
patients with COPD.
Study objective
To quantify the effectiveness of one- legged exercise training in improving
functional status of patients with COPD in comparison to two- legged exercise
training during a 10 week pulmonary rehabilitation programme.
Study design
Patients will be randomly allocated to the one-legged or the two-legged
exercise training group after completing baseline assessments. Both the groups
train three times per week for a 10 week period, with 20 minute training
sessions (without the w-up and c-down period). The one legged warming- up
lasts 4 minutes, 2 minutes for each leg. The intensity for the warming-up for
the 1L- group is set at 20% Wmax attained on the baseline one- legged
incremental cycle test. Patients of the one- legged group start the test
session with the leg they used at the start of the warming-up. The goal of the
training sessions is to train with maximum intensity for a period of 20
minutes. If necessary, intensity will be reduced to obtain 20 minutes of
cycling in the first training session. Patients of the 1L- group switch leg
after 2 minutes of cycling during the training session. The 1L- group start the
training session at an intensity of 60% Wmax attained on the baseline one-
legged incremental test. Intensity of training in the training session is
lowered when patients are not able to obtain 20 minutes of interval training
(excluding the warming up and cooling down period). Training intensity will be
increased by 5W when exercise duration (20 min) is reached for two successive
sessions. Patients will be encouraged by the same person every test and in the
same manner. Water will be available on request. Patients are free to stop the
training session at any time without consequences. After the training session
there is an 4 minutes one- legged cooling- down period.
Time trial performance, ventilatory parameters, quality of life (QOL),
activities of daily living (ADL), physical activity energy expenditure (PAEE),
dyspnea and exercise capacity parameters will be measured.
Patients of the 2L- group cycle with two legs in the 4 minutes warming- up. The
intensity for the warming- up for the 2L- group is set at 20% Wmax attained on
the baseline two- legged incremental test. The goal of the training sessions is
to train at maximum training intensity/workload for a period of 20 minutes
(excluding the warming up and cooling down). If necessary, intensity will be
reduced to obtain 20 minutes of continuous cycling. The 2L- group cycle with
two legs during the training sessions. They start the training session at 60%
Wmax attained on the baseline two- legged incremental test. Intensity of
training in the training session is lowered when patients are not able to
obtain 20 minutes of interval training. Training intensity will be increased by
5W when exercise duration (20 min) is reached for two successive sessions. Toe
clips are used to keep the feet on the pedals during exercise training.
Patients will be encouraged by the same person every session and in the same
manner. Water will be available on request. Patients are free to stop the
training session at any time without consequences. After the training session
there is a 4 minutes two- legged cooling- down period. Time trial performance,
ventilatory parameters, quality of life (QOL), activities of daily living
(ADL), physical activity energy expenditure (PAEE), dyspnea and exercise
capacity parameters will be measured.
Intervention
One leg training. Patients in the one- legged group switch leg after 2 minutes
of cycling during the training session on an electromechanically braked cycle.
Patients can rest their inactive foot on a crossbar of the ergometer.
Study burden and risks
The risk and burden of this study is deemed minimal in comparison to regular
exercise training in lung rehabilitation programmes. Patients with
comorbidities that limit their exercise tolerance will not be included in this
study.
Exercise training is seen as an important part of pulmonary rehabilitation of
patients with COPD. In this study in one group, two- legged endurance
rehabilitation training is replaced by one- legged endurance rehabilitation
training. Using one- legged training instead of two- legged training does not
involve any risks for the patients. Moreover, they are expected to experience
less dyspnea (shortness of breath).
The ventilatory parameters measured in this study are routinely measured during
the assessments of new COPD patients in pulmonary rehabilitation centers. There
are no risks involved in using the different questionnaires of activity in
daily living (ADL).
Exercise training
Exercise training is seen as an important part of pulmonary rehabilitation of
patients with COPD. Using one- legged training instead of habitual two- legged
training does not involve any additional risk for the patients in the one-
legged exercise training group. Moreover, they are expected to experience less
dyspnea (shortness of breath). Dolmage et al 9 showed that cyclic one- legged
exercise training improved aerobic capacity compared with conventional two-
legged training in patients with COPD.
The ventilatory parameters (FEV1, FVC, Peak VE, Peak VO2, Peak CO2, SaO2),
measured in this study are routinely measured during the assessments of new
COPD patients in pulmonary rehabilitation centers so there is no additional
risk in measuring these parameters. The burden of using different
questionnaires of activity in daily living (ADL), dyspnea and quality of life
(QOL) is deemed minimal.
Time trial tests
Time trial test protocols are frequently used to evaluate performance before
and after training in healthy subjects. Time trial test protocols appear to be
more reliable than open ended test protocols since their reproducibility is
higher. The use of these time trial test to evaluate performance is now
globally accepted. There are no additional risks of these time trial endurance
exercise performance tests in comparison with the routinely used open-ended
endurance exercise performance test, and therefore the risk of use of a time
trial test in patients with COPD patients is deemed minimal.
Activity and heart rate monitoring by Actiheart
Accelerometry has no recorded risks despite its widespread use. Actiheart
monitors are placed on the chest with ECG electrodes and have been specifically
designed to cause minimal discomfort, weighing around 8 grams. Patients undergo
cardio-pulmonary stress tests before allocation to the compact programme group,
and therefore it is unlikely for unexpected ECG-abberations to be detected
during Actiheart monitoring.
The single discomfort that is known to occasionally arise from the wearing of
Actiheart monitors is minor skin-irritation from the ECG-electrodes. If at any
time during the measurements subjects should indicate any hindrance or
discomfort from the Actiheart, they will be asked if they wish to take the
monitor off, and it will be repeated to them that they can end their
participation at any moment without any consequence. Subjects can contact
either the main investigator or the independent medical doctor at any time
during the course of the study should they have questions regarding protocol
adherence or any other questions related to the study.
Additional information:
The patients in this study will receive an invitation letter, containing a
written explanation of the aims and procedures of the study and a verbal
explanation;
Attached to the invitation letter, an explanation about the insurance will be
provided
Patients can contact investigator drs. Willem Gosens and the independent MD
before, during, and after the study.
The data will be analysed, described, and kept by W. Gosens, PhD student.
Patients can end their participation at any point without explanation.
Universiteitssingel 50
Postbus 616, 6200 MD, Maastricht
Nederland
Universiteitssingel 50
Postbus 616, 6200 MD, Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
•patient has provided written informed consent;
•patient is diagnosed with COPD (FEV1 / FVC postbronchodilatoir < 70%);
•patient is clinically stable;
•patient has stopped smoking;
•patient has an indication for lung rehabilitation
Exclusion criteria
•patient is hypoxic at rest (PaO2 < 55 mg Hg)
•patient has experienced exacerbations in the last 8 weeks before commencement of the study
•patient has problems adapting to the disease, requiring a more behavioural intervention (extended programme).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL26791.068.09 |