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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031173
Receipt No. R000035589
Scientific Title Combined effect of progressive resistance training and physical activity counseling in patients with chronic obstructive pulmonary disease: a randomized controlled crossover study.
Date of disclosure of the study information 2018/02/06
Last modified on 2018/10/14

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Basic information
Public title Combined effect of progressive resistance training and physical activity counseling in patients with chronic obstructive pulmonary disease: a randomized controlled crossover study.
Acronym Combined effect of progressive resistance training and physical activity counseling in patients with COPD
Scientific Title Combined effect of progressive resistance training and physical activity counseling in patients with chronic obstructive pulmonary disease: a randomized controlled crossover study.
Scientific Title:Acronym Combined effect of progressive resistance training and physical activity counseling in patients with COPD
Region
Japan

Condition
Condition COPD patients
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study investigated the effects of combined progressive resistance training (PRT) and counseling on physical activity in patients with chronic obstructive pulmonary disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The evaluations were performed at baseline and post the intervention(after 8 week).
The primary outcomes were assessed by measuring PA using a pedometer and quadriceps muscle strength (QS) using a dynamometer, muscle thickness and echo intensity, body composition.
Key secondary outcomes The secondary outcomes were assessed to grip strength, COPD assessment test, Timed up and go test, 5 repetition stand time, hospital anxiety and depression scale (HADS), the Nagasaki university respiratory ADL questionnaire, SGRQ, SF-36, mini nutritional assessment, life space assessment, 6-minute walk test, Instruction manual of Japanese version of Montreal cognitive assessment.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Participants in the PRT group completed an 8-week program involving once a week PRT and counseling. The PRT group performed four resistance training sessions(squat, leg extension, calf raises, stair climbing), wherein the load on the modified Borg scale was 4-7 per set; each week the set or number of repetitions, intensity was increased, or the rest time between sets was decreased. Counseling was done via pedometer feedback.
Interventions/Control_2 CON group maintained their usual lifestyle(8 week).
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Study inclusion criteria were patients diagnosed with COPD based on GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria.
Key exclusion criteria Exclusion criteria were patients within 1 month of an exacerbation, and those with a comorbidity including cardiac failure, heart pacemakers, diabetes, rheumatoid arthritis or orthopedic surgery.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiharu Fujisawa
Organization Shinko Hospital
Division name Rehabilitation Center
Zip code
Address 1-4-47, Wakinohamacho, Chuo-ku, Kobe
TEL 078-261-6711
Email chiharu.fujisawa@shinkohp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiharu Fujisawa
Organization Shinko Hospital
Division name Rehabilitation Center
Zip code
Address 1-4-47, Wakinohamacho, Chuo-ku, Kobe
TEL 078-261-6711
Homepage URL
Email chiharu.fujisawa@shinkohp.or.jp

Sponsor
Institute Shinko Hospital
Institute
Department

Funding Source
Organization Japan Science and Technoligy Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 02 Month 06 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 Completed
Date of protocol fixation
2016 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 04 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
2018 Year 02 Month 06 Day
Last modified on
2018 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035589

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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