Multiple SclerosisNCT04416243
Feasibility of a High-intensity Interval Training Program in Persons With Multiple Sclerosis Who Have Walking Disability
A study testing Recumbent Stepping, High-Intensity Interval Training in people with Multiple Sclerosis, run by University of North Texas, Denton, TX at 1 site in United States.
Trial summary
There is considerable evidence to support the efficacy of moderate intensity continuous (MIC) exercise benefitting clinically-relevant outcomes in persons with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Recumbent Stepping, High-Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 14 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or over
- a self-reported diagnosis of multiple sclerosis
- self-reported Expanded Disability Status Scale (EDSS) score < 8.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 7.0
- relapse free in past 30 days
- willing and able to visit Berry College or University of North Texas on three testing occasions and twenty four training occasions
- asymptomatic status for maximal exercise testing; (g) physician approval for undertaking exercise testing
- a self-reported ability to speak, read, and understand English
Who cannot join
- Any persons who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-group, Feasibility, and Initial Efficacy Study of a High-intensity Interval Training Program Using Adaptive Equipment in Persons With Multiple Sclerosis Who Have Walking Disability
There is considerable evidence to support the efficacy of moderate intensity continuous (MIC) exercise benefitting clinically-relevant outcomes in persons with multiple sclerosis (MS). However, persons with MS who have walking impairments (pwMS-wd) are severely deconditioned and may achieve superior benefits by engaging in high-intensity interval training (HIIT), especially while utilizing adaptive equipment, such as with recumbent arm/leg stepping (RSTEP). Of the published studies on HIIT in MS, HIIT yielded significant improvements in cardiorespiratory fitness in all but one study. In those studies that directly compared HIIT to MIC exercise, the data indicated a potential superiority of HIIT as compared to MIC in improving physiological conditioning in a time efficient manner. However, this evidence is specific to those with MS with mild to moderate disability engaging in cycle/arm ergometry and an investigation of HIIT in pwMS-wd is needed as the feasibility and potential benefits of engaging in HIIT in pwMS-wd is relatively unknown.
The primary aim of the proposed study is to assess the feasibility of a 12-week, RSTEP HIIT program in pwMS-wd. The secondary aim is to examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms as clinically-relevant efficacy outcomes following the 12-week, RSTEP HIIT intervention. It is hypothesized that the intervention will be feasible and lead to positive changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms. This work is informed by recently published data, which indicate that a single bout of RSTEP HIIT taxes the cardiorespiratory system significantly more than MIC exercise, yet without untoward effects on walking, gait, cognition, mood, or enjoyment. These data suggest that RSTEP HIIT may be an acceptable, safe, and tolerable stimulus for chronic exercise training.
- Conditions
- Multiple Sclerosis
- Being tested
- Recumbent Stepping, High-Intensity Interval Training
- Keywords
- multiple sclerosis, adaptive equipment, rehabilitation, recumbent stepping, high-intensity interval training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recumbent Stepping, High-Intensity Interval TrainingBehavioural
The intervention will involve 12 weeks of supervised, progressive (i.e., intensity increases after midpoint testing based on reassessment of aerobic fitness) HIIT sessions two to three times per week. HIIT exercise sessions will be manualized and led by exercise leaders. Secondary outcomes testing will occur at baseline (week 0), midpoint (following week 6 of training), and post-intervention (following week 12 of training).
The individual HIIT sessions will involve 10 cycles of 60s intervals at the wattage associated with 90% VO2peak followed by 60s of active recovery intervals at 15 watts, totaling 20 min in length. All exercise sessions will begin and end with a 5-minute warm-up and cool-down, respectively. Required power output for each interval of the exercise session will be individualized and completely automated. VO2peak from baseline and midpoint testing will be used to determine exercise intensity for weeks 1-6 and weeks 7-12, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Recumbent Stepping, High-Intensity Interval Training | Experimental | Not described Receives: Behavioral: Recumbent Stepping, High-Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment, Retention, and Adherence Rates
Participant recruitment, retention, and adherence rates will be recorded.
Measured: From recruitment to end of treatment at 12 weeks.
Time Needs
Staff training, communication, recruitment, and intervention time will be recorded.
Measured: From recruitment to end of treatment at 12 weeks.
Monetary Needs
Monetary research costs will be recorded.
Measured: From recruitment to end of treatment at 12 weeks.
Data Management and Safety Reporting
Time from submission of Institutional Review Board application to approval will be recorded. All time spent collecting, entering, and checking data will be recorded.
Measured: From recruitment to end of treatment at 12 weeks.
Participant Burden Reporting
Participants' experience, burden, and perceptions will be assessed via a short survey at the end of the 12 weeks.
Measured: From recruitment to end of treatment at 12 weeks.
Safety Reporting
Adverse events, serious adverse events, and clinical emergencies will be recorded.
Measured: From recruitment to end of treatment at 12 weeks.
Secondary outcomes (8)
Change in Aerobic Capacity
Participants will complete a standardized graded maximal exercise step on a recumbent stepper. The highest recorded 30-second volume of oxygen consumption (VO2) value will be recorded as VO2peak, expressed in mL/kg/min, when at least 1 of the following criteria are satisfied: (1) respiratory exchange ratio 1.10 or greater; (2) peak heart rate within 10 beats per minute of age-predicted maximum(i.e., 220-age); or (3) ratings of perceived exertion of 7 or greater.
Measured: Week 0, Following Week 6, Following Week 12
Change in 6-Minute Walk Distance
Participants will walk for a total of 6 minutes along a single course 75-feet in length with two, 180-degree turns. Total distance travelled (ft) will be recorded.
Measured: Week 0, Following Week 6, Following Week 12
Change in 25-Foot Walk Speed
Participants will be instructed to walk as fast as possible along a 25-foot path. Participants time recorded as walking speed (ft/s) will be collected twice. The average of the two trials will be reported.
Measured: Week 0, Following Week 6, Following Week 12
Change in Sedentary, Light, and Moderate-to-Vigorous Counts of Physical Activity
Participants will be asked to wear an accelerometer for 7 consecutive days for a minimum of 10 hours of wear time. Using the accelerometer software, sedentary, light, and moderate-to-vigorous counts of physical activity will be generated based on disability status.
Measured: Week 0, Following Week 6, Following Week 12
Change in the Brief International Cognitive Assessment in MS Scores
Participants will complete the oral version of the Symbol Digit Modalities Test, the first five recall trials of the California Verbal Learning Test-2, and the first three recall trials of the Brief Visuospatial Memory Test-Revised. The Symbol Digit Modalities Test reports the correct number of responses with a maximum score of 110. The California Verbal Learning test reports the total number of correct words identified over five trials, with a maximum score of 90. The Brief Visuospatial Memory Test-Revised reports the total raw score across the three trials, with a maximum score of 36.
Measured: Week 0, Following Week 6, Following Week 12
Change in 9-Hole Peg Test Score
Participants are instructed to pick up pegs and place them one at a time into one of nine holes as fast as possible and then to remove the pegs, one at a time, with the same hand. The time (s) to complete this activity will be recorded and averaged on two trials for the dominant hand and then the non-dominant hand.
Measured: Week 0, Following Week 6, Following Week 12
Change in Fatigue Scores
Participants will be asked to complete the Fatigue Severity Scale, which is a self-report measure comprised of 9 items that assess the severity of fatigue symptoms. This Likert scale ranges from 1 (strongly disagree) and 7 (strongly agree) and measures the degree of fatigue severity over the past week. All items will be summed for a final score with higher scores indicating greater fatigue severity and a maximum score of 63.
Measured: Week 0, Following Week 6, Following Week 12
Change in Depressive Symptoms Scores
Depressive symptoms will be measured by the Depression sub-scale of the Hospital Anxiety and Depression Scale (HADS-D). The HADS-D includes 7 items that measure depression and are rated on a 4-point scale ranging between 0 (not at all) to 3 (most of the time). Positively worded items are reverse-scored and then added with negatively worded items to create a total sum with a maximum value of 21.
Measured: Week 0, Following Week 6, Following Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start19 Dec 2019
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas, Denton, TX
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Berry College
- Responsible party
- Principal investigator, Stephanie Silveira, University of North Texas, Denton, TX
- Investigators
- Stephanie L Silveira, PhD, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416243
- Sponsor's protocol ID
- 2018-19-24
- Status last verified
- Apr 2023
- First submitted
- 28 May 2020
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hubbard EA, Motl RW, Elmer DJ. Feasibility and initial efficacy of a high-intensity interval training program using adaptive equipment in persons with multiple sclerosis who have walking disability: study protocol for a single-group, feasibility trial. Trials. 2020 Nov 25;21(1):972. doi: 10.1186/s13063-020-04887-x.
PubMed 33239079
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-group, Feasibility, and Initial Efficacy Study of a High-intensity Interval Training Program Using Adaptive Equipment in Persons With Multiple Sclerosis Who Have Walking Disability
- ClinicalTrials.gov ID
- NCT04416243
- Acronym / sponsor ID
- 2018-19-24
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, adaptive equipment, rehabilitation, recumbent stepping, high-intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of North Texas, Denton, TXUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Berry College
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 4 Jun 2020 (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.
There is considerable evidence to support the efficacy of moderate intensity continuous (MIC) exercise benefitting clinically-relevant outcomes in persons with multiple sclerosis (MS). However, persons with MS who have walking impairments (pwMS-wd) are severely deconditioned and may achieve superior benefits by engaging in high-intensity interval training (HIIT), especially while utilizing adaptive equipment, such as with recumbent arm/leg stepping (RSTEP). Of the published studies on HIIT in MS, HIIT yielded significant improvements in cardiorespiratory fitness in all but one study. In those studies that directly compared HIIT to MIC exercise, the data indicated a potential superiority of HIIT as compared to MIC in improving physiological conditioning in a time efficient manner. However, this evidence is specific to those with MS with mild to moderate disability engaging in cycle/arm ergometry and an investigation of HIIT in pwMS-wd is needed as the feasibility and potential benefits of engaging in HIIT in pwMS-wd is relatively unknown.
The primary aim of the proposed study is to assess the feasibility of a 12-week, RSTEP HIIT program in pwMS-wd. The secondary aim is to examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms as clinically-relevant efficacy outcomes following the 12-week, RSTEP HIIT intervention. It is hypothesized that the intervention will be feasible and lead to positive changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms. This work is informed by recently published data, which indicate that a single bout of RSTEP HIIT taxes the cardiorespiratory system significantly more than MIC exercise, yet without untoward effects on walking, gait, cognition, mood, or enjoyment. These data suggest that RSTEP HIIT may be an acceptable, safe, and tolerable stimulus for chronic exercise training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recumbent Stepping, High-Intensity Interval Training | Experimental | Behavioral: Recumbent Stepping, High-Intensity Interval Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 or over
- a self-reported diagnosis of multiple sclerosis
- self-reported Expanded Disability Status Scale (EDSS) score < 8.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 7.0
- relapse free in past 30 days
- willing and able to visit Berry College or University of North Texas on three testing occasions and twenty four training occasions
Key exclusion criteria (1 listed)
- Any persons who do not meet the inclusion criteria
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 |
|---|---|---|
| Recumbent Stepping, High-Intensity Interval TrainingThe intervention will involve 12 weeks of supervised, progressive (i.e., intensity increases after midpoint testing based on reassessment of aerobic fitness) HIIT sessions two to three times per week. HIIT exercise sessions will be manualized and led by exercise leaders. Secondary outcomes testing will occur at baseline (week 0), midpoint (following week 6 of training), and post-intervention (following week 12 of training). The individual HIIT sessions will involve 10 cycles of 60s intervals at the wattage associated with 90% VO2peak followed by 60s of active recovery intervals at 15 watts, totaling 20 min in length. All exercise sessions will begin and end with a 5-minute warm-up and cool-down, respectively. Required power output for each interval of the exercise session will be individualized and completely automated. VO2peak from baseline and midpoint testing will be used to determine exercise intensity for weeks 1-6 and weeks 7-12, respectively. | Behavioural | Recumbent Stepping, High-Intensity Interval Training |
Primary outcome
Recruitment, Retention, and Adherence Rates
Time frame: From recruitment to end of treatment at 12 weeks.
Participant recruitment, retention, and adherence rates will be recorded.
Time Needs
Time frame: From recruitment to end of treatment at 12 weeks.
Staff training, communication, recruitment, and intervention time will be recorded.
Monetary Needs
Time frame: From recruitment to end of treatment at 12 weeks.
Monetary research costs will be recorded.
Data Management and Safety Reporting
Time frame: From recruitment to end of treatment at 12 weeks.
Time from submission of Institutional Review Board application to approval will be recorded. All time spent collecting, entering, and checking data will be recorded.
Participant Burden Reporting
Time frame: From recruitment to end of treatment at 12 weeks.
Participants' experience, burden, and perceptions will be assessed via a short survey at the end of the 12 weeks.
Safety Reporting
Time frame: From recruitment to end of treatment at 12 weeks.
Adverse events, serious adverse events, and clinical emergencies will be recorded.
8 secondary outcomes
Change in Aerobic Capacity
Time frame: Week 0, Following Week 6, Following Week 12
Change in 6-Minute Walk Distance
Time frame: Week 0, Following Week 6, Following Week 12
Change in 25-Foot Walk Speed
Time frame: Week 0, Following Week 6, Following Week 12
Change in Sedentary, Light, and Moderate-to-Vigorous Counts of Physical Activity
Time frame: Week 0, Following Week 6, Following Week 12
Change in the Brief International Cognitive Assessment in MS Scores
Time frame: Week 0, Following Week 6, Following Week 12
Change in 9-Hole Peg Test Score
Time frame: Week 0, Following Week 6, Following Week 12
Change in Fatigue Scores
Time frame: Week 0, Following Week 6, Following Week 12
Change in Depressive Symptoms Scores
Time frame: Week 0, Following Week 6, Following Week 12
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 19 Apr 2023.
- Derived from this study: PubMed 33239079Hubbard EA, Motl RW, Elmer DJ. Feasibility and initial efficacy of a high-intensity interval training program using adaptive equipment in persons with multiple sclerosis who have walking disability: study protocol for a single-group, feasibility trial. Trials. 2020 Nov 25;21(1):972. doi: 10.1186/s13063-020-04887-x.
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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.
Stephanie L Silveira, PhD principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recumbent Stepping, High-Intensity Interval Training in people with Multiple Sclerosis, run by University of North Texas, Denton, TX 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 7 inclusion and 1 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 19 Apr 2023. 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?
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?
Recruitment, Retention, and Adherence Rates (time frame: From recruitment to end of treatment at 12 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416243, which also lists 1 linked publication.
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 19 Apr 2023.