Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors | NCT03479632

Studies
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

NCT03479632

Sponsor

University of Kansas Medical Center

Status

Unknown status

Last Update Posted

Mar 8, 2019Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

Aerobic walking program
Standard physical therapy

Countries

United States

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 2019

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 5, 2018Actual

Primary Completion Date

Dec 5, 2019Estimated

Completion Date

Mar 5, 2020Estimated

First Submitted Date

Mar 19, 2018

First Submission Date that Met QC Criteria

Mar 19, 2018

First Posted Date

Mar 27, 2018Actual

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

Mar 7, 2019

Last Update Posted Date

Mar 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental	The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device.	Behavioral: Aerobic walking program
Control Group	Active Comparator	The control group will receive standard physical therapy (PT).	Behavioral: Standard physical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerobic walking program	Behavioral	Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.	Intervention Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting Heart Rate		Change from Baseline to Week 8

Secondary Outcomes

Measure	Description	Time Frame
Resting blood pressure		Change from Baseline to Week 8
Change in vital capacity (VC)		Change from Baseline to Week 8
Change in forced vital capacity (FVC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Independent ambulation before stroke
Be able to understand and follow verbal commands in English
Have physicians' approval for exercise, and be in stable medical condition
Participant's first stroke
Unable to walk independently according to Functional Ambulation Category (FAC) (<2) after in-patient rehabilitation treatment
Between 6 weeks to 5 years after stroke onset

Exclusion Criteria:

Current cardiovascular abnormalities other than stroke such as ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
Musculoskeletal disorder which prevents subjects from participating in the exercise
Resting blood pressure more than 200/110 mm Hg
Current or previous pulmonary diseases in the past two years
Osteoporosis and restricted passive movement in the major joints of the lower limbs
Subjects will be excluded if they are unable to speak or understand English and/or unable to travel to the University of Kansas Medical Center (KUMC) Neuromuscular Research Laboratory

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdulfattah Alqahtani	Contact	832-228-8799		aalqahtani@kumc.edu

Overall Officials

Name	Affiliation	Role
Wen Liu	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center	Recruiting	Kansas City	Kansas	66160	United States

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