Unique ID issued by UMIN | UMIN000009849 |
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Receipt number | R000011526 |
Scientific Title | Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric - |
Date of disclosure of the study information | 2013/02/01 |
Last modified on | 2015/07/23 09:33:23 |
Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric -
Appropriate evaluation metric of exercise training for COPD
Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric -
Appropriate evaluation metric of exercise training for COPD
Japan |
Chronic obstructive pulmonary disease
Medicine in general | Pneumology |
Others
NO
To find the appropriate metric to evaluate the effect of exercise training, the exercise training will be performed for 8 weeks in patients with severe to very severe COPD, evaluating the changes in their symptoms, blood biomarkers, nutritional status, and exercise capacities. In addition, in patients with weight loss (body mass index (BMI) of less than 21 kg/m2) and those without weight loss (BMI of 21 kg/m2 or more), whether the evaluation metric affects the outcomes of exercise training will also be investigated.
Others
To find the appropriate metric to evaluate the effect of exercise training.
Exploratory
Pragmatic
Not applicable
The evaluations will be done 3 times:
i) at Week 4,
ii) at Week 8 soon after pulmonary rehabilitation (PR), and
iii) at Week 12 (i.e., 4 weeks after the completion of PR).
As primary outcomes, we will examine the correlation between the change in exercise capacity (peak oxygen uptake) and the plasma ghrelin level.
As secondary outcomes, we will examine the correlations between the changes in exercise capacity (peak oxygen uptake) and i) other blood biomarkers, including plasma vascular endothelial growth factor (VEGF) level, ii) weight, iii) pulmonary function test results, iv) food intake, v) free-living physical activity measured by an accelerometer, vi) DEXA (measurement of lean body mass, body mineral content, and fat mass), vii) symptoms, and viii) respiratory muscle strength.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Educational,Counseling,Training
Behavior,custom |
Pulmonary rehabilitation including exercise training for 8 weeks on an outpatient basis. Exercise training will be conducted in 3 sets daily, 3 times a week for 8 weeks (i.e., 24 days) using electromechanically braked cycle ergometers. The initial exercise level of each set will be set for 6 min at the work rate corresponding to 40% of the peak oxygen uptake achieved on the baseline cardiopulmonary exercise testing (CPET). As tolerated by the subject, the exercise duration will be initially increased to 10 min. After that, the training work rate will be increased by 5 W and then extended to the work rate corresponding to 80% of the baseline peak oxygen uptake.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Severe to very severe COPD (forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) of less than 70% and FEV1 percent predicted of less than 50%) (after using a bronchodilator)
2) Clinically stable and able to participate in pulmonary rehabilitation
3) Between 20 and 85 years old
4) Signed the agreement for participation in this study
1) Malignant tumours
2) Active infection
3) Severe heart disease
4) Hepatic dysfunction (serum aspartate aminotransferase and alanine aminotransferase levels at least twice the upper limit of normal)
5) Renal dysfunction (serum creatinine levels of 2.0 mg/dL or more)
6) Asthma (after the inhalation of salbutamol, 12% or more reversibility compared to the FEV1 before inhalation and 200 mL or more improvement of FEV1)
7) Definitely or possibly pregnant
8) Change in drug regimen within 4 weeks before participation in this study
9) Judged to be unable to participate in this study by their physician.
20
1st name | |
Middle name | |
Last name | Ryoji Maekura |
National Hospital Organization Toneyama National Hospital, Toyonaka, Japan
Department of Respiratory Medicine, Deputy Director
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
06-6853-2001
rmaekura@toneyama.go.jp
1st name | |
Middle name | |
Last name | Keisuke Miki |
National Hospital Organization Toneyama National Hospital, Toyonaka, Japan
Dep. of Respiratory Medicine, and Lab. Chief, Lab. of Respiratory Science, Div. of Clinical Research
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
06-6853-2001
mikisuke@toneyama.go.jp
National Hospital Organization Toneyama National Hospital
National Hospital Organization
Other
NO
2013 | Year | 02 | Month | 01 | Day |
Unpublished
Open public recruiting
2012 | Year | 12 | Month | 12 | Day |
2013 | Year | 02 | Month | 01 | Day |
2013 | Year | 01 | Month | 23 | Day |
2015 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011526
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