UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009849 |
|---|---|
| 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 |
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Basic information
Public title
Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric -
Acronym
Appropriate evaluation metric of exercise training for COPD
Scientific Title
Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric -
Scientific Title:Acronym
Appropriate evaluation metric of exercise training for COPD
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Others
Basic objectives -Others
To find the appropriate metric to evaluate the effect of exercise training.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoji Maekura |
Organization
National Hospital Organization Toneyama National Hospital, Toyonaka, Japan
Division name
Department of Respiratory Medicine, Deputy Director
Zip code
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL
06-6853-2001
rmaekura@toneyama.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Miki |
Organization
National Hospital Organization Toneyama National Hospital, Toyonaka, Japan
Division name
Dep. of Respiratory Medicine, and Lab. Chief, Lab. of Respiratory Science, Div. of Clinical Research
Zip code
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL
06-6853-2001
Homepage URL
mikisuke@toneyama.go.jp
Sponsor or person
Institute
National Hospital Organization Toneyama National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 23 | Day |
Last modified on
| 2015 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011526
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