Early Intervention With a Low-intensity Leg Cycling Exerc... | NCT02437006

Studies
Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke

NCT02437006

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Unknown status

Last Update Posted

May 7, 2015Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

exercise

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Mar 31, 2015

First Submission Date that Met QC Criteria

May 4, 2015

First Posted Date

May 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2015

Last Update Posted Date

May 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are recruited, and they are assessed and recorded with clinical characteristics, sympathetic nerve testing, and twice symptom-limit exercise capacity tests. The second stage would recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three groups (control, low-intensity, high-intensity). They are evaluated before and after the four-week interval with clinical characteristics and twice symptom-limit exercise capacity tests (baseline and after four-week training) .

Detailed Description

This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are recruited, and they are assessed and recorded with sympathetic nerve testing, anthropometry, and twice symptom-limit exercise capacity tests.The second stage would recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three groups. The control group undergoes traditional rehabilitation only, The low-intensity exercise group receives a low-intensity four-week cycle ergometry and traditional rehabilitation. The The high-intensity exercise group gets a high-intensity four-week cycle ergometry and traditional rehabilitation. They are evaluated by sympathetic tests, anthropometry, functional scales and activity questionnaires, and symptom-limit exercise capacity tests before and after the four-week training.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rehabilitation	No Intervention	half an hour physical and half an hour occupational therapy in rehabilitation
Low-intensity exercise	Experimental	Low-intensity exercise plus rehabilitation	Other: exercise
High-intensity exercise	Experimental	High-intensity exercise plus rehabilitation	Other: exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise	Other	cycle ergometry	High-intensity exercise Low-intensity exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change values of symptom-limit exercise capacity	value was showed by oxygen uptake (mL/kg/min)	baseline and after four-week training

Secondary Outcomes

Measure	Description	Time Frame
change values of sympathetic nerve tests	change value was measure by blood pressure (from lying to stand, mm-Hg) at baseline and after four weeks	baseline and after four-week training

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stroke onset longer than two weeks,
eligible for exercise testing by Doctor

Exclusion Criteria:

aphasia,
apraxia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miao-Ju Hsu, PHD	Contact	88673121101	2673	mjhsu@kmu.edu.tw

Overall Officials

Name	Affiliation	Role
Miao-Ju Hsu, PHD	Kaohsiung Medical University, College of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University, College of Health Sciences	Recruiting	Kaohsiung City		807	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided