UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042295 |
|---|---|
| Receipt number | R000048287 |
| Scientific Title | Effect of home-based exercise therapy for peripheral arterial disease patients underwent endovascular treatment: A clinical controlled design |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2021/05/05 18:10:54 |
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Basic information
Public title
Effect of home-based exercise therapy for peripheral arterial disease patients underwent endovascular treatment
Acronym
Effect of home-based exercise therapy for peripheral arterial disease patients underwent endovascular treatment
Scientific Title
Effect of home-based exercise therapy for peripheral arterial disease patients underwent endovascular treatment: A clinical controlled design
Scientific Title:Acronym
Effect of home-based exercise therapy for peripheral arterial disease patients underwent endovascular treatment: A clinical controlled design
Region
| Japan |
Condition
Condition
Peripheral arterial disease
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the effect of home-based exercise therapy on physical activity in PAD patients after EVT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity (number of steps)
Key secondary outcomes
WIQ, SEPA, Vascu QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Remaining home-based exercise therapy guidance for patients with peripheral arterial disease after endovascular treatment, focusing on remote guidance.
Telephone instruction 2 times.(1 and 2 weeks after discharge)
Physical activity survey using a triaxial accelerometer and mailing the results 3 times.(3 times every other month for 3 months after discharge)
Interventions/Control_2
Physical activity in patients with peripheral arterial disease after endovascular treatment.
Physical activity survey using a triaxial accelerometer: 3 times every other month for 3 months.
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with peripheral arterial disease who have undergone endovascular treatment at the Sakakibara Heart Institute of Okayama and who have given consent for the study.
Key exclusion criteria
(1) unable to walk independently before EVT; (2) diagnosis of dementia; (3) lower extremity amputation; (4) critical limb ischemia; (5) not responding to the post-discharge survey; and (6) missing data.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Otsuka |
Organization
Sakakibara Heart Institute of Okayama
Division name
Department of Rehabilitation
Zip code
700-0804
Address
2-5-1,Nakai-cho,Kita-ku,Okayama city,Okayama,Japan
TEL
0862257111
qqqz3sm9k@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Otsuka |
Organization
Sakakibara Heart Institute of Okayama
Division name
Department of Rehabilitation
Zip code
700-0804
Address
2-5-1,Nakai-cho,Kita-ku,Okayama city,Okayama,Japan
TEL
0862257111
Homepage URL
qqqz3sm9k@gmail.com
Sponsor or person
Institute
Sakakibara Heart Institute of Okayama
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics committee of Sakakibara Heart Institute of Okayama
Address
2-5-1,Nakai-cho,Kita-ku,Okayama city,Okayama,Japan
Tel
0862257111
Sakakibara-hp@sakakibara-hp.com
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
| 2020 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/ptr/advpub/0/advpub_E10056/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/ptr/advpub/0/advpub_E10056/_article/-char/ja
Number of participants that the trial has enrolled
30
Results
The main outcome, the number of steps, increased significantly in the intervention group before and 3 months after discharge.
The sub-outcome quality of life indexes, WIQ pain score and speed score, increased significantly in the intervention group at 3 months after surgery. Significant increases in SEPA were only found in the intervention group before and 3 months after discharge.
Results date posted
| 2020 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PAD patients who underwent EVT according to the TASC classification.
Participant flow
After EVT, all patients began standing and walking exercises the day after surgery. After independence in walking, exercise therapy with a treadmill was started according to TASC II.
After discharge, the control group received no additional instruction and physical activity was measured every month.
The intervention group received telephone instruction every 1 or 2 weeks and physical activity measurements and written instruction every month.
Adverse events
None
Outcome measures
The primary outcome: the change in the number of steps from pre-EVT to 3 months after discharge. Secondary outcomes: WIQ, SEPA and Vascu QOL.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048287
