Multiple Sclerosis, ProgressiveNCT02950454
The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.
A study testing High intensity interval training and Continuous moderate exercise in people with Multiple Sclerosis, Progressive, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Progressive
- What is being tested?
- High intensity interval training and Continuous moderate exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with a progressive form of MS
- Aged 18 years or older
- Known to members of staff of the MS service NHS Ayrshire \& Arran
- Ability to attend Douglas Grant Rehabilitation centre twice a week for eight weeks
- EDSS 4-6.0
- Able to cycle on ergometer
Who cannot join
- A relapse of symptoms requiring treatment within the past three months.
- A respiratory condition that would be exacerbated by high intensity exercise including but not limited to: chronic obstructive pulmonary disorder, uncontrolled or poorly controlled asthma.
- Uncontrolled high pressure at screening (>190/100 mmHg)
- Cognitive impairment affecting ability to understand instructions as noted in patient's notes.
- Currently engaging in another research trial for their MS or that may affect their physiological or cardiovascular outcomes
- Weighing more than 110 kg (weight limit of ergometer)
Show all 9Show fewer
- Any pathology or medical intervention that would preclude high intensity exercise, maximal exertion testing or could attenuate the cardiovascular effect of exercise including but not limited to: unstable angina; diabetes; peripheral vascular disease or intermittent claudication; having a pace maker or medicine pump; surgical clips; having another neurological condition other than MS; and pregnancy. To be established from patient's notes and at screening session.
- A serious cardiovascular event in the past year including but not limited to: transient ischaemic attack, cerebrovascular event and myocardial infarction.
- Taking any of the following medication: beta blockers; vasodilators; ACE inhibitors; diuretics or any other medication that could cause exercise induced hypotension; hypoglycaemic insulin; metformin or other oral insulin medicine.
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks.
Read the detailed description
This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks.
The training program will entail 6x1.5 minute intervals working at 80-95% heart rate max on a cycle ergometer. Each interval will be interspersed with 1.5 minutes of working rest at a light resistance of the participant's choosing.
The continuous moderate intensity exercise program will entail 20 minutes on a cycle ergometer working at 60-70% heart rate max.
- Conditions
- Multiple Sclerosis, Progressive
- Being tested
- High intensity interval training, Continuous moderate exercise
- Keywords
- Progressive Multiple Sclerosis, Rehabilitation, Exercise
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingOther
1.5 min intervals at 80-95% heart rate max on cycle ergometer 1.5 min intervals at nominal resistance on cycle ergometer
Continuous moderate exerciseOther
20 min at 60-70% heart rate max on cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 8 weeks of twice weekly high intensity interval training. Session protocol: 2 minute warm up at nominal resistance on cycle ergometer, 6 six intervals of 80-95% heart rate max interspersed with 6 intervals of 1.5 minute working rest. Then 3 minutes cool down. Receives: Other: High intensity interval training |
| control | Active comparator | 8 weeks of twice weekly continuous moderate intensity exercise. Session protocol: 2 minutes warm up at nominal resistance on cycle ergometer, 20 minutes at 60-70% heart rate max. Then 3 minutes cool down. Receives: Other: Continuous moderate exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate max
Maximal heart rate elicited during a maximal exertion test
Measured: 8 weeks
Secondary outcomes (10)
Resting blood pressure
Measured: 8 weeks
Resting heart rate
Measured: 8 weeks
Brain derived neurotrophic factor
Hormone important for brain growth and protection
Measured: 8 weeks
Lactate
Waste materials from exercise in blood
Measured: 8 weeks
Lipoprotein profile
Indication of how much good and how much bad cholesterol is in blood
Measured: 8 weeks
MSIS-29 version 2
Questionnaire giving physical and psychological impact of MS
Measured: 8 weeks
Hospital anxiety and depression scale
Questionnaire giving a score of depression and anxiety
Measured: 8 weeks
Timed 25 foot walk test
Measure of walking speed
Measured: 8 weeks
Symbol digit modalities test
Measure of mental processing speed
Measured: 8 weeks
Fatigue severity scale
Questionnaire which gives measure of fatigue.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, ProgressiveStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Ayrshire and Arran, AKM
- Responsible party
- Principal investigator, Evan Campbell, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950454
- Sponsor's protocol ID
- 1.0
- Status last verified
- Oct 2017
- First submitted
- 28 Oct 2016
- Last updated
- 25 Oct 2017
- 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 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT02950454
- Acronym / sponsor ID
- 1.0
- Conditions
- Multiple Sclerosis, Progressive
- Keywords
- Progressive Multiple Sclerosis, Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Ayrshire and Arran, AKM
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 1 Nov 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.
This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks.
Detailed description
This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks.
The training program will entail 6x1.5 minute intervals working at 80-95% heart rate max on a cycle ergometer. Each interval will be interspersed with 1.5 minutes of working rest at a light resistance of the participant's choosing.
The continuous moderate intensity exercise program will entail 20 minutes on a cycle ergometer working at 60-70% heart rate max.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: High intensity interval training8 weeks of twice weekly high intensity interval training. Session protocol: 2 minute warm up at nominal resistance on cycle ergometer, 6 six intervals of 80-95% heart rate max interspersed with 6 intervals of 1.5 minute working rest. Then 3 minutes cool down. |
| control | Active comparator | Other: Continuous moderate exercise8 weeks of twice weekly continuous moderate intensity exercise. Session protocol: 2 minutes warm up at nominal resistance on cycle ergometer, 20 minutes at 60-70% heart rate max. Then 3 minutes cool down. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with a progressive form of MS
- Aged 18 years or older
- Known to members of staff of the MS service NHS Ayrshire \& Arran
- Ability to attend Douglas Grant Rehabilitation centre twice a week for eight weeks
- EDSS 4-6.0
Key exclusion criteria (9 listed)
- A relapse of symptoms requiring treatment within the past three months.
- A respiratory condition that would be exacerbated by high intensity exercise including but not limited to: chronic obstructive pulmonary disorder, uncontrolled or poorly controlled asthma.
- Uncontrolled high pressure at screening (>190/100 mmHg)
- Cognitive impairment affecting ability to understand instructions as noted in patient's notes.
- Currently engaging in another research trial for their MS or that may affect their physiological or cardiovascular outcomes
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 training1.5 min intervals at 80-95% heart rate max on cycle ergometer 1.5 min intervals at nominal resistance on cycle ergometer | Other | Intervention |
| Continuous moderate exercise20 min at 60-70% heart rate max on cycle ergometer | Other | control |
Primary outcome
heart rate max
Time frame: 8 weeks
Maximal heart rate elicited during a maximal exertion test
10 secondary outcomes
Resting blood pressure
Time frame: 8 weeks
Resting heart rate
Time frame: 8 weeks
Brain derived neurotrophic factor
Time frame: 8 weeks
Lactate
Time frame: 8 weeks
Lipoprotein profile
Time frame: 8 weeks
MSIS-29 version 2
Time frame: 8 weeks
Hospital anxiety and depression scale
Time frame: 8 weeks
Timed 25 foot walk test
Time frame: 8 weeks
Symbol digit modalities test
Time frame: 8 weeks
Fatigue severity scale
Time frame: 8 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 25 Oct 2017.
- 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.
1 site 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 and Continuous moderate exercise in people with Multiple Sclerosis, Progressive, run by University of Glasgow at 1 site 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 6 inclusion and 9 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 25 Oct 2017. 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 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?
heart rate max (time frame: 8 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 25 Oct 2017.