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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048287


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name