The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke

NCT02855424 | Unknown DMC

• 1 other identifier: KUMHIRB-F(II)-2016002
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Poor cardiopulmonary endurance is observed in individuals with acute stroke, even in chronic. In addition, the poor fitness may obstacle activities of daily life, decrease activities of autonomic system, and increase risks of recurrent, therefore, the cardiopulmonary endurance training should be included into the early-stage rehabilitation program. The ergocycling training could improve cardiopulmonary endurance for individuals with stroke. Moreover, the low-intensity exercise training can increase the willingness, and it is safer than the moderate-intensity exercise training. However, it needs to be evaluated whether the low-intensity exercise training can bring sufficient benefits, compared to the moderate-intensity exercise training. Objectives of the study is to compare the exercise benefits between the low-intensity and moderate-intensity exercise training, and then these would offer optimal exercise prescription and considerations in clinical practice.

Conditions

Stroke

Keywords

stroke; exercise capacity

Outcome Measures

Primary Outcomes (1)

• changed value of symptom-limit exercise tolerance tests

  One doctor and one therapist monitor the test. EKG and self-report are used.

  Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up

Secondary Outcomes (7)

• changed activity of autonomic nervous system (ANS)

  Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up

• 10-meter walking test

  Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up

• changed score of the Barthel index

  Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up

• changed score of the Stroke-Specific Quality of Life Scale (SSQOL)

  Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up

• changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)

  Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up

Study Arms (3)

control

NO INTERVENTION

traditional rehabilitation merely, no ergocycling training

the low-intensity exercise group

EXPERIMENTAL

traditional rehabilitation plus the low-intensity ergocycling exercise training

Other: the low-intensity exercise group

the moderate-intensity exercise group

EXPERIMENTAL

traditional rehabilitation plus the moderate-intensity ergocycling exercise training

Other: the moderate-intensity exercise group

Interventions

the low-intensity exercise group OTHER

Totally 20-time training, frequency 2-6 time/week, total 20 times.

the low-intensity exercise group

the moderate-intensity exercise group OTHER

Totally 20-time training, frequency 2-6 time/week,total 20 times.

the moderate-intensity exercise group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the first-ever stroke
• period of ischemic stroke onset is longer than two weeks, and less than six months, and the doctors agree with exercise training
• unilateral hemiplegia
• no obvious deficits of cognition. Scores of three items in the National Institutes of Health Stroke Scale are zero
• be willing to join this study and give their consent

You may not qualify if:

• aphasia
• orthopedic problems (severe arthritis), neurologic injury (eg. peripheral nerve injury) that can interfere with movement of the lower limb, or cannot sit independently
• with pace maker, severe cardiac arrhythmia, or heart failure
• abnormal electrocardiography in rest, is not suitable for exercise tolerance test according to the American College of Sports Medicine guidance, for example, the atrioventricular block (AV block).

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Miao-Ju Hsu, PHD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miao-Ju Hsu, PHD

CONTACT

886-7-3121101; mjhsu@kmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: August 4, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: August 5, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share