Multiple Sclerosis, EnduranceNCT02726373
Comparison of Intermittent vs. Continuous Walking in MS
A study testing type of walking in people with Multiple Sclerosis, Endurance, run by Hunter College of City University of New York.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Endurance
- What is being tested?
- type of walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effect of Intermittent vs. Continuous Walking Training on Walking Endurance and Fatigue in People With Multiple Sclerosis: a Randomized, Crossover Trial.
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.
- Conditions
- Multiple Sclerosis, Endurance
- Being tested
- type of walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type of walkingOther
Subjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over
| Study group | Role | What they receive |
|---|---|---|
| Intermittent walking training | Experimental | Not described Receives: Other: type of walking |
| Continuous Walking Training | Active comparator | Not described Receives: Other: type of walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre to post change in 6 Minute walk test distance
Measured: 4 weeks
Secondary outcomes (1)
Visual Analog Scale of fatigue
Measurements to be taken at baseline and after each 4 week intervention
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, EnduranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herb Karpatkin, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726373
- Sponsor's protocol ID
- INTCON1
- Status last verified
- Mar 2016
- First submitted
- 30 Mar 2016
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent vs. Continuous Walking Training on Walking Endurance and Fatigue in People With Multiple Sclerosis: a Randomized, Crossover Trial.
- ClinicalTrials.gov ID
- NCT02726373
- Acronym / sponsor ID
- INTCON1
- Conditions
- Multiple Sclerosis, Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent walking training | Experimental | Other: type of walking |
| Continuous Walking Training | Active comparator | Other: type of walking |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| type of walkingSubjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over | Other | Continuous Walking Training, Intermittent walking training |
Primary outcome
Pre to post change in 6 Minute walk test distance
Time frame: 4 weeks
1 secondary outcome
Visual Analog Scale of fatigue
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing type of walking in people with Multiple Sclerosis, Endurance, run by Hunter College of City University of New York.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre to post change in 6 Minute walk test distance (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.