NCT02437006

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) .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 7, 2015

Status Verified

March 1, 2014

Enrollment Period

3 years

First QC Date

March 31, 2015

Last Update Submit

May 4, 2015

Conditions

Stroke

Keywords

strokeexercise capacity

Outcome Measures

Primary Outcomes (1)

  • change values of symptom-limit exercise capacity

    value was showed by oxygen uptake (mL/kg/min)

    baseline and after four-week training

Secondary Outcomes (1)

  • change values of sympathetic nerve tests

    baseline and after four-week training

Study Arms (3)

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

exerciseOTHER

cycle ergometry

High-intensity exerciseLow-intensity exercise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • aphasia,
  • apraxia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University, College of Health Sciences

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Miao-Ju Hsu, PHD

    Kaohsiung Medical University, College of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miao-Ju Hsu, PHD

CONTACT

88673121101mjhsu@kmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

May 7, 2015

Study Start

March 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 7, 2015

Record last verified: 2014-03

Locations

TW(1)