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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02726373
Other study ID # INTCON1
Secondary ID
Status Completed
Phase N/A
First received March 30, 2016
Last updated March 31, 2016
Start date January 2013
Est. completion date December 2014

Study information

Verified date March 2016
Source Hunter College
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
type of walking
Subjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hunter College

Outcome

Type Measure Description Time frame Safety issue
Primary Pre to post change in 6 Minute walk test distance 4 weeks No
Secondary Visual Analog Scale of fatigue Measurements to be taken at baseline and after each 4 week intervention 4 weeks No