Multiple SclerosisHIIT-MSNCT02702804
High Intensity Interval Training for People With Mild Multiple Sclerosis: A Feasibility Study
A study testing High Intensity Interval Training in people with Multiple Sclerosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Exercise has been shown to improve quality of life in people with multiple sclerosis but most exercise programmes are carried out at low to moderate intensities. The next stage in the management of the condition is to establish if people with mild Multiple Sclerosis can exercise, safely and effectively at a higher… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- High Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Apr 2016to 8 Nov 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of MS more than three months
- EDSS score of less than 2.5
- Aged 18-65
- No more than one relapse in the last 2 years
- Participants on disease modifying therapy (Interferon and Grateramer Acetate) must have been stable on this treatment for at least 3 months prior to entering the study
Who cannot join
- Failure to meet any of the inclusion criteria
- Experiencing illness or injury that impairs their ability to be physically active
- Living more than 20 miles away from Centre for Sport and Exercise Science
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Sheffield Hallam University
Sheffield, South Yorkshire, S10 2BP
Royal Hallamshire Hospital
Sheffield, S10 2JF
About this study
Exercise has been shown to improve quality of life in people with multiple sclerosis but most exercise programmes are carried out at low to moderate intensities. The next stage in the management of the condition is to establish if people with mild Multiple Sclerosis can exercise, safely and effectively at a higher intensity. High intensity interval training (HIIT) involves repeated bursts of hard exercise interspersed with periods of rest. High intensity interval trainingcould be a time efficient and safe option for people with Multiple Sclerosis. Potential improvements are; cardiovascular fitness, resistance to fatigue, balance, quality of life and attitude to physical exercise.
Participants will attend two sessions per week for 6 weeks. Each session will involve 6-10 sets of 60 seconds of high intensity cycling followed by 60 seconds rest. Potential participants must have a clinical diagnosis of Mulitple Sclerosis for more than 3 months, an EDSS score of less than 2.5, aged 18-65, and had no more than one relapse in the last 2 years.
From this study the investigators hope to discover if High Intensity Interval Training is a safe and enjoyable form of physical activity for people with mild Multiple Sclerosis. This will then hopefully lead to further large research trials.
Read the detailed description
Multiple Sclerosis is an autoimmune disease that is typically progressive and involves damage to the nerve cells in the central nervous system. Living with multiple sclerosis can be a difficult experience both physically and psychologically. Some of the most common symptoms for people with MS include excessive fatigue, limb weakness, motor abnormalities and sexual dysfunction with symptoms dependant on the central nervous system pathology. Multiple Sclerosis is the most common cause of disability in young to middle aged adults in the developing world. The relatively high incidence rates and longitudinal nature of the condition has a large economic impact on the health care system, people with Multiple Sclerosis and their families. Treatments are now able to better manage the condition but there is still no cure and the fundamental cause is still unknown, so symptom management and maintenance of function is crucial. Exercise and rehabilitation are increasingly being looked at to allow patients to better manage their condition and assist people with multiple sclerosis to self-manage their care.
For many years people with multiple sclerosis have limited their activity levels to in order to not exasperate their symptoms. Since then research has shown that supervised exercise (aerobic and strength) training can be beneficial for people with mild to moderate multiple sclerosis. Current evidence now suggests that exercise may actually go even further than improving function and better managing symptoms in multiple sclerosis, but may actually have a disease modifying effect, suggesting that guidance for long-term prescription is imperative.
High intensity interval training (HIIT) describes exercise that is characterised by short bursts of vigorous effort followed by periods of rest or low intensity exercise. High intensity interval trainingis an extremely variable mode of exercise with sessions altered by intensity, duration and number of intervals as well as the duration and activity chosen during the rest period. High intensity interval training has been shown to be an effective alternative to traditional endurance training so often used in exercise interventions. It has also been suggested that High intensity interval trainingis more enjoyable than moderate intensity exercise. These findings are important because lack of time and lack of enjoyment are two of the most commonly quoted barriers to regular activity.
The project utilises a pre-experimental one-group pre-test - post-test design. The participants will be assessed at baseline, followed by an intervention and then measured again at follow up.Patients will be purposively recruited from the multiple sclerosis clinic at the Royal Hallamshire Hospital in Sheffield. Potential participants will be identified by consultant neurologists to the research assistant from clinic lists/patient records. Patients who satisfy the inclusion and exclusion criteria will be given/sent a recruitment letter and participant information sheet informing them about the study. The letter will contain a tear-off slip for patients to return to the research team indicating their interest or not in study participation. It will be clearly stated in the letter that there is no obligation or pressure to participate and that if patients are not interested their future medical care will not be jeopardised. Patients who respond to the letter of invitation will be invited into the Centre for Sport and Exercise Science for a consultation.
Once a participant has been recruited and provided informed consent they will attend a baseline assessment. Each participant will undergo a VO2peak test on a cycle ergometer. Gas measurement will be conducted breath by breath by means of telemetric spirometry, heart rate will be measured by Polar system. The test will be conducted to volitional exhaustion or will be terminated when any of the following criteria are met:
- symptom exacerbation
- symptoms indicating risk for the safety or health of the patients
- plateau in oxygen uptake with increasing workload and/ or
- respiratory exchange rate greater than 1.15
Three questionnaires will be administered to the participants to determine the effects of the exercise interventions on physical activity level (Godin Leisure Time Questionnaire), fatigue (modified fatigue impact scale), and health perception (SF-36). Participants will also be given an ActiGraph accelerometer to wear for 7-days. The procedures will be repeated at follow up by a blinded assessor.
Participants will attend two sessions per week for the 6 week intervention. Each session will consist of 6-10 sets of 60 second high intensity intervals interspersed with 60 seconds recovery. The workload during each interval will be set at 80-90% of peak power achieved during the VO2peak test. This is predicted to elicit 85-95% heart rate reserve in the participants. After each interval the participant's heart rate and rate of perceived exertion (RPE) will be collected. After each session a researcher will complete an Adverse Event form to record if an event occurred or not. Additionally the participant will complete a physical activity enjoyment (Perceived activity enjoyment scale) after one session per week.
Outcomes will be assessed at two-time-points: baseline and after the 6-week intervention. Personal characteristics (e.g. postcode, marital status ethnicity, etc.) and condition specific data (e.g. time since diagnosis, medication, onset of symptoms, use of health care resources etc.) will be collected.
- Conditions
- Multiple Sclerosis
- Being tested
- 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.
High Intensity Interval TrainingOther
High Intensity Interval Training
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | Participants will attend two sessions per week for the 6 week intervention. Each session will consist of 6-10 sets of 60 second high intensity intervals interspersed with 60 seconds recovery. The workload during each interval will be set at 80-90% of peak power achieved during the VO2peak test. This is predicted to elicit 85-95% heart rate reserve in the participants. After each interval the participant's heart rate and rate of perceived exertion (RPE) will be collected. After each session a researcher will complete an Adverse Event form to record if an event occurred or not. Additionally the participant will complete a physical activity enjoyment (Perceived activity enjoyment scale) after one session per week. Receives: Other: High Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited to the study who adhere to high intensity interval training intervention
Adherence will be measured through attendance to the exercise sessions and compliance to the prescribed intensity
Measured: 12 months
Number of participants with treatment related adverse events as recorded by the research team
The research team will complete an adverse event form after each session, stating whether any adverse events occurred or not. For additional safety monitoring participants will be given a diary to record how they feel immediately after the exercise session, several hours after and the next day.
Measured: 12 months
Secondary outcomes (3)
Physical fitness
changes to physical fitness will be measured using the VO2peak cycle ergometer test
Measured: baseline and at 6 weeks which is study completion
Impact of treatment intervention on multiple sclerosis
Number of Participants with Adverse Events That Are Related to Treatment intervention
Measured: baseline and at 6 weeks which is study completion
Impact of treatment intervention on multiple sclerosis
Number of participants who record changes on the quality of life questions due to the impact of treatment
Measured: baseline and at 6 weeks which is study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start21 Apr 2016
- Primary completionNov 2017
- Study completion8 Nov 2017
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University
- Responsible party
- Sponsor
- Investigators
- Basil Sharrack, Professor, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702804
- Sponsor's protocol ID
- STH18899
- Acronym
- HIIT-MS
- Status last verified
- Aug 2018
- First submitted
- 18 Feb 2016
- Last updated
- 14 Nov 2019
- 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 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training for People With Mild Multiple Sclerosis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02702804
- Acronym / sponsor ID
- HIIT-MS / STH18899
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 9 Mar 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.
Exercise has been shown to improve quality of life in people with multiple sclerosis but most exercise programmes are carried out at low to moderate intensities. The next stage in the management of the condition is to establish if people with mild Multiple Sclerosis can exercise, safely and effectively at a higher intensity. High intensity interval training (HIIT) involves repeated bursts of hard exercise interspersed with periods of rest. High intensity interval trainingcould be a time efficient and safe option for people with Multiple Sclerosis. Potential improvements are; cardiovascular fitness, resistance to fatigue, balance, quality of life and attitude to physical exercise.
Participants will attend two sessions per week for 6 weeks. Each session will involve 6-10 sets of 60 seconds of high intensity cycling followed by 60 seconds rest. Potential participants must have a clinical diagnosis of Mulitple Sclerosis for more than 3 months, an EDSS score of less than 2.5, aged 18-65, and had no more than one relapse in the last 2 years.
From this study the investigators hope to discover if High Intensity Interval Training is a safe and enjoyable form of physical activity for people with mild Multiple Sclerosis. This will then hopefully lead to further large research trials.
Detailed description
Multiple Sclerosis is an autoimmune disease that is typically progressive and involves damage to the nerve cells in the central nervous system. Living with multiple sclerosis can be a difficult experience both physically and psychologically. Some of the most common symptoms for people with MS include excessive fatigue, limb weakness, motor abnormalities and sexual dysfunction with symptoms dependant on the central nervous system pathology. Multiple Sclerosis is the most common cause of disability in young to middle aged adults in the developing world. The relatively high incidence rates and longitudinal nature of the condition has a large economic impact on the health care system, people with Multiple Sclerosis and their families. Treatments are now able to better manage the condition but there is still no cure and the fundamental cause is still unknown, so symptom management and maintenance of function is crucial. Exercise and rehabilitation are increasingly being looked at to allow patients to better manage their condition and assist people with multiple sclerosis to self-manage their care.
For many years people with multiple sclerosis have limited their activity levels to in order to not exasperate their symptoms. Since then research has shown that supervised exercise (aerobic and strength) training can be beneficial for people with mild to moderate multiple sclerosis. Current evidence now suggests that exercise may actually go even further than improving function and better managing symptoms in multiple sclerosis, but may actually have a disease modifying effect, suggesting that guidance for long-term prescription is imperative.
High intensity interval training (HIIT) describes exercise that is characterised by short bursts of vigorous effort followed by periods of rest or low intensity exercise. High intensity interval trainingis an extremely variable mode of exercise with sessions altered by intensity, duration and number of intervals as well as the duration and activity chosen during the rest period. High intensity interval training has been shown to be an effective alternative to traditional endurance training so often used in exercise interventions. It has also been suggested that High intensity interval trainingis more enjoyable than moderate intensity exercise. These findings are important because lack of time and lack of enjoyment are two of the most commonly quoted barriers to regular activity.
The project utilises a pre-experimental one-group pre-test - post-test design. The participants will be assessed at baseline, followed by an intervention and then measured again at follow up.Patients will be purposively recruited from the multiple sclerosis clinic at the Royal Hallamshire Hospital in Sheffield. Potential participants will be identified by consultant neurologists to the research assistant from clinic lists/patient records. Patients who satisfy the inclusion and exclusion criteria will be given/sent a recruitment letter and participant information sheet informing them about the study. The letter will contain a tear-off slip for patients to return to the research team indicating their interest or not in study participation. It will be clearly stated in the letter that there is no obligation or pressure to participate and that if patients are not interested their future medical care will not be jeopardised. Patients who respond to the letter of invitation will be invited into the Centre for Sport and Exercise Science for a consultation.
Once a participant has been recruited and provided informed consent they will attend a baseline assessment. Each participant will undergo a VO2peak test on a cycle ergometer. Gas measurement will be conducted breath by breath by means of telemetric spirometry, heart rate will be measured by Polar system. The test will be conducted to volitional exhaustion or will be terminated when any of the following criteria are met:
- symptom exacerbation
- symptoms indicating risk for the safety or health of the patients
- plateau in oxygen uptake with increasing workload and/ or
- respiratory exchange rate greater than 1.15
Three questionnaires will be administered to the participants to determine the effects of the exercise interventions on physical activity level (Godin Leisure Time Questionnaire), fatigue (modified fatigue impact scale), and health perception (SF-36). Participants will also be given an ActiGraph accelerometer to wear for 7-days. The procedures will be repeated at follow up by a blinded assessor.
Participants will attend two sessions per week for the 6 week intervention. Each session will consist of 6-10 sets of 60 second high intensity intervals interspersed with 60 seconds recovery. The workload during each interval will be set at 80-90% of peak power achieved during the VO2peak test. This is predicted to elicit 85-95% heart rate reserve in the participants. After each interval the participant's heart rate and rate of perceived exertion (RPE) will be collected. After each session a researcher will complete an Adverse Event form to record if an event occurred or not. Additionally the participant will complete a physical activity enjoyment (Perceived activity enjoyment scale) after one session per week.
Outcomes will be assessed at two-time-points: baseline and after the 6-week intervention. Personal characteristics (e.g. postcode, marital status ethnicity, etc.) and condition specific data (e.g. time since diagnosis, medication, onset of symptoms, use of health care resources etc.) will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Other: High Intensity Interval TrainingParticipants will attend two sessions per week for the 6 week intervention. Each session will consist of 6-10 sets of 60 second high intensity intervals interspersed with 60 seconds recovery. The workload during each interval will be set at 80-90% of peak power achieved during the VO2peak test. This is predicted to elicit 85-95% heart rate reserve in the participants. After each interval the participant's heart rate and rate of perceived exertion (RPE) will be collected. After each session a researcher will complete an Adverse Event form to record if an event occurred or not. Additionally the participant will complete a physical activity enjoyment (Perceived activity enjoyment scale) after one session per week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical Diagnosis of MS more than three months
- EDSS score of less than 2.5
- Aged 18-65
- No more than one relapse in the last 2 years
- Participants on disease modifying therapy (Interferon and Grateramer Acetate) must have been stable on this treatment for at least 3 months prior to entering the study
Key exclusion criteria (3 listed)
- Failure to meet any of the inclusion criteria
- Experiencing illness or injury that impairs their ability to be physically active
- Living more than 20 miles away from Centre for Sport and Exercise Science
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 |
|---|---|---|
| High Intensity Interval TrainingHigh Intensity Interval Training | Other | High Intensity Interval Training |
Primary outcome
Number of participants recruited to the study who adhere to high intensity interval training intervention
Time frame: 12 months
Adherence will be measured through attendance to the exercise sessions and compliance to the prescribed intensity
Number of participants with treatment related adverse events as recorded by the research team
Time frame: 12 months
The research team will complete an adverse event form after each session, stating whether any adverse events occurred or not. For additional safety monitoring participants will be given a diary to record how they feel immediately after the exercise session, several hours after and the next day.
3 secondary outcomes
Physical fitness
Time frame: baseline and at 6 weeks which is study completion
Impact of treatment intervention on multiple sclerosis
Time frame: baseline and at 6 weeks which is study completion
Impact of treatment intervention on multiple sclerosis
Time frame: baseline and at 6 weeks which is study completion
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 14 Nov 2019.
- 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.
Basil Sharrack, Professor principal investigator
Sheffield Teaching Hospitals NHS FT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training in people with Multiple Sclerosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
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 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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Number of participants recruited to the study who adhere to high intensity interval training intervention (time frame: 12 months). The study lists 2 primary outcomes in all. 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 14 Nov 2019.