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

NCT ID: NCT02437006

Last Updated: 2015-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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rehabilitation

half an hour physical and half an hour occupational therapy in rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Low-intensity exercise

Low-intensity exercise plus rehabilitation

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

cycle ergometry

High-intensity exercise

High-intensity exercise plus rehabilitation

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

cycle ergometry

Interventions

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exercise

cycle ergometry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* aphasia,
* apraxia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miao-Ju Hsu, PHD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University, College of Health Sciences

Locations

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Kaohsiung Medical University, College of Health Sciences

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Miao-Ju Hsu, PHD

Role: CONTACT

88673121101 ext. 2673

Facility Contacts

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Miao-Ju Hsu, PHD

Role: primary

886-7-3121101 ext. 2673

Other Identifiers

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KMUH-IRB- 20130376

Identifier Type: -

Identifier Source: org_study_id

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