Comparison of Intermittent vs. Continuous Walking in MS | NCT02726373

Studies
Comparison of Intermittent vs. Continuous Walking in MS

NCT02726373

Sponsor

Hunter College of City University of New York

Status

Completed

Last Update Posted

Apr 4, 2016Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Multiple Sclerosis, Endurance

Interventions

type of walking

Countries

Not provided

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 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 30, 2016

First Submission Date that Met QC Criteria

Mar 30, 2016

First Posted Date

Apr 1, 2016Estimated

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 31, 2016

Last Update Posted Date

Apr 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Herb Karpatkin, Assistant Professor, Hunter College of City University of New YorkPrincipal Investigator

Lead Sponsor

Hunter College of City University of New YorkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective: To compare effects of an intermittent and continuous walking program on walking endurance and fatigue in people with multiple sclerosis (MS).A randomized crossover prospective method was used.The intervention consisted of eight 6-minute-long walks (2x/week for 4 weeks). The continuous condition consisted of 6 continuous minutes of walking. The intermittent condition consisted of three 2-minute bouts with 2-minute rests. After a 4-week detraining period, participants performed the second training condition.

Detailed Description

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intermittent walking training	Experimental		Other: type of walking
Continuous Walking Training	Active Comparator		Other: type of walking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
type of walking	Other	Subjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over	Continuous Walking Training Intermittent walking training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pre to post change in 6 Minute walk test distance		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Visual Analog Scale of fatigue	Measurements to be taken at baseline and after each 4 week intervention	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive diagnosis of MS
Ambulatory for at least 6 minutes with or without an assistive device (e.g. cane, crutches or orthotics)
Ability to read, understand, and sign an informed consent form

Exclusion Criteria:

Evidence of exacerbation in the prior three months as defined by a treating physician
Orthopedic or cardiovascular condition that would interfere with ability to walk for 6 continuous minutes,
Currently being on an active physical rehabilitation program

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided