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

K

Kaohsiung Medical University

Status

Unknown

Conditions

Stroke

Treatments

Other: exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT02437006
KMUH-IRB- 20130376

Details and patient eligibility

About

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) .

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • aphasia,
  • apraxia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

120 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Miao-Ju Hsu, PHD

Data sourced from clinicaltrials.gov

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