UMIN-CTR Clinical Trial

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
Email	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
Email	qqqz3sm9k@gmail.com

Sponsor
Institute	Sakakibara Heart Institute of Okayama
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048287