Multiple SclerosisNCT03963492
Intermittent vs Continuous Walking in People With Multiple Sclerosis
A study testing Walking in people with Multiple Sclerosis, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study will compare the effectiveness of a traditional, continuous walking rehabilitation program for people with MS to the novel intervention of an intermittent or interval walking rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 28 Feb 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified difficulty walking
- Definitive diagnosis of multiple sclerosis from a neurologist
- Signed an approved consent form
- Ability to ambulate for unaided for 6-minutes continuously with or without an assistive device (e.g. a cane or brace)
- Has not had a multiple sclerosis relapse in the past 6 weeks
Who cannot join
- Unwilling or unable to complete assessments
- Unwilling or able to complete assessments and or intervention without the use of portable functional electrical stimulation devices
- Medical history of concomitant condition unrelated to multiple sclerosis which may impact results including: other neurological conditions including stroke, Parkinson's disease, or orthopedic, or cardiopulmonary conditions that affect walking
- Had a major change in exercise habits in the past three months
- Individuals reporting change in any disease modifying treatment or steroid use during the past 6 weeks
- Unable to walk for 6 minutes continuously without physical assistance
Show all 10Show fewer
- Medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of deep vein thrombosis, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes
- Has an abnormal response to exercise
- Cannot adhere to protocol
- Determined to be unsafe at the discretion of the research team including individuals unwilling to wear safety "gait belt" during testing or not willing to wear proper footwear.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, 06112
About this study
Official title: Intermittent vs. Continuous Walking Training in People With Multiple Sclerosis: a Comparison of Effectiveness
This study will compare the effectiveness of a traditional, continuous walking rehabilitation program for people with MS to the novel intervention of an intermittent or interval walking rehabilitation program. Half of the participants will receive the continuous walking program while the other half will receive the novel intermittent walking program.
Read the detailed description
The typical rehabilitation of walking difficulties for people with MS has included practice walking. In general, this includes training to build walking endurance by having the person with MS walk until he/she becomes tired and needs to stop. Although this model has been used successfully to treat people with other diagnoses, it has limited effectiveness in improving walking ability and endurance in people with MS because of fatigue. Recently, a different model has been considered: intermittent or interval walking training. Interval walking training is organized such that seated rest breaks are intentionally interspersed between walking training bouts that end before the person with MS becomes too tired to continue. Exploratory research has shown that people with MS can walk faster and farther when using interval walking training, and may have more improvements in walking ability and endurance after using interval walking training. This study will compare the effectiveness of the traditional model of continuous walking training to the promising new model of interval walking training. This will help to determine whether interval or continuous walking training is superior in improving walking ability and endurance in people with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Walking
- Keywords
- Walking, Gait, Fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingOther
Participants will undergo training in either the CONT or INT walking interventions 2x/week for 6 weeks for a total plan of 12 training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Walking | Active comparator | Participants in the Continuous Walking (CONT) arm will undergo training 2x/week for 6 weeks for a total plan of 12 training sessions. The intervention for the CONT group will be to complete a 6-minute long walk without rest breaks Receives: Other: Walking |
| Interval Walking | Experimental | Participants in the Interval Walking (INT) arm will undergo training 2x/week for 6 weeks for a total plan of 12 training sessions. The intervention for the (INT) group will be to complete three 2-minute-long walks with 2-minute seated rest breaks between each walk Receives: Other: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute Walk Test distance
Is a measurement of the distance (in meters) walked at best pace in six minutes.
Measured: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Secondary outcomes (6)
Change in 12-item Multiple Sclerosis Walking Scale score
A survey that measures a participant's perception of how his/her walking ability is affected by multiple sclerosis. The scale ranges from 0-100 with lower scores representing a lesser impact of multiple sclerosis on the participant's walking ability. There are no subscales.
Measured: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Fatigue Severity Scale score
A survey that measures a participant's perception of the impact of the symptom of fatigue on a person's ability to participate in life roles. The scale ranges from from 9-63, with lower scores representing a lower impact of fatigue on the ability to perform the activities listed in the scale.There are no subscales.
Measured: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Step Length
The distance (in centimeters) traversed in one step from initial contact of one foot to the initial contact of the opposite foot.
Measured: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Step Time
The time (in seconds) taken to complete one step from initial contact of one foot to the initial contact of the opposite foot.
Measured: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Stride Velocity
The speed with which it takes a person to complete one stride from initial contact of one foot to the next initial contact of the same foot
Measured: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Cadence
The number of steps (the initial contact of one foot to the initial contact of the opposite foot taken per minute
Measured: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Jul 2019
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Randomized controlled pre-post study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Rehabilitation Hospital, City University of New York, School of Public Health
- Responsible party
- Principal investigator, Evan T. Cohen, SHRP Department of Rehabilitation and Movemen, Rutgers, The State University of New Jersey
- Investigators
- Evan T Cohen, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963492
- Sponsor's protocol ID
- Pro2019000453
- Status last verified
- May 2022
- First submitted
- 16 May 2019
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent vs. Continuous Walking Training in People With Multiple Sclerosis: a Comparison of Effectiveness
- ClinicalTrials.gov ID
- NCT03963492
- Acronym / sponsor ID
- Pro2019000453
- Conditions
- Multiple Sclerosis
- Keywords
- Walking, Gait, Fatigue
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 Pandemic
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Mount Sinai Rehabilitation Hospital, City University of New York, School of Public Health
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 24 May 2019 (actual)
- 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.
This study will compare the effectiveness of a traditional, continuous walking rehabilitation program for people with MS to the novel intervention of an intermittent or interval walking rehabilitation program. Half of the participants will receive the continuous walking program while the other half will receive the novel intermittent walking program.
Detailed description
The typical rehabilitation of walking difficulties for people with MS has included practice walking. In general, this includes training to build walking endurance by having the person with MS walk until he/she becomes tired and needs to stop. Although this model has been used successfully to treat people with other diagnoses, it has limited effectiveness in improving walking ability and endurance in people with MS because of fatigue. Recently, a different model has been considered: intermittent or interval walking training. Interval walking training is organized such that seated rest breaks are intentionally interspersed between walking training bouts that end before the person with MS becomes too tired to continue. Exploratory research has shown that people with MS can walk faster and farther when using interval walking training, and may have more improvements in walking ability and endurance after using interval walking training. This study will compare the effectiveness of the traditional model of continuous walking training to the promising new model of interval walking training. This will help to determine whether interval or continuous walking training is superior in improving walking ability and endurance in people with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled pre-post study
| Arm | Type | Receives |
|---|---|---|
| Continuous Walking | Active comparator | Other: WalkingParticipants in the Continuous Walking (CONT) arm will undergo training 2x/week for 6 weeks for a total plan of 12 training sessions. The intervention for the CONT group will be to complete a 6-minute long walk without rest breaks |
| Interval Walking | Experimental | Other: WalkingParticipants in the Interval Walking (INT) arm will undergo training 2x/week for 6 weeks for a total plan of 12 training sessions. The intervention for the (INT) group will be to complete three 2-minute-long walks with 2-minute seated rest breaks between each walk |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identified difficulty walking
- Definitive diagnosis of multiple sclerosis from a neurologist
- Signed an approved consent form
- Ability to ambulate for unaided for 6-minutes continuously with or without an assistive device (e.g. a cane or brace)
- Has not had a multiple sclerosis relapse in the past 6 weeks
Key exclusion criteria (10 listed)
- Unwilling or unable to complete assessments
- Unwilling or able to complete assessments and or intervention without the use of portable functional electrical stimulation devices
- Medical history of concomitant condition unrelated to multiple sclerosis which may impact results including: other neurological conditions including stroke, Parkinson's disease, or orthopedic, or cardiopulmonary conditions that affect walking
- Had a major change in exercise habits in the past three months
- Individuals reporting change in any disease modifying treatment or steroid use during the past 6 weeks
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 |
|---|---|---|
| WalkingParticipants will undergo training in either the CONT or INT walking interventions 2x/week for 6 weeks for a total plan of 12 training sessions. | Other | Continuous Walking, Interval Walking |
Primary outcome
Change in 6-minute Walk Test distance
Time frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Is a measurement of the distance (in meters) walked at best pace in six minutes.
6 secondary outcomes
Change in 12-item Multiple Sclerosis Walking Scale score
Time frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Fatigue Severity Scale score
Time frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Step Length
Time frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Step Time
Time frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Stride Velocity
Time frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Change in Cadence
Time frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- 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.
Evan T Cohen, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking in people with Multiple Sclerosis, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 5 inclusion and 10 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: paused, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Change in 6-minute Walk Test distance (time frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)). 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 12 May 2022.