The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.

Conditions
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Multiple Sclerosis, Progressive

Intervention / Treatment
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* Other: High intensity interval training
* Other: Continuous moderate exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: High intensity interval training<br>* 1.5 min intervals at 80-95% heart rate max on cycle ergometer 1.5 min intervals at nominal resistance on cycle ergometer<br>|
| Active Comparator: control<br>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. | Other: Continuous moderate exercise<br>* 20 min at 60-70% heart rate max on cycle ergometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate max | Maximal heart rate elicited during a maximal exertion test | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting blood pressure |  | 8 weeks | 
| Resting heart rate |  | 8 weeks | 
| Brain derived neurotrophic factor | Hormone important for brain growth and protection | 8 weeks | 
| Lactate | Waste materials from exercise in blood | 8 weeks | 
| Lipoprotein profile | Indication of how much good and how much bad cholesterol is in blood | 8 weeks | 
| MSIS-29 version 2 | Questionnaire giving physical and psychological impact of MS | 8 weeks | 
| Hospital anxiety and depression scale | Questionnaire giving a score of depression and anxiety | 8 weeks | 
| Timed 25 foot walk test | Measure of walking speed | 8 weeks | 
| Symbol digit modalities test | Measure of mental processing speed | 8 weeks | 
| Fatigue severity scale | Questionnaire which gives measure of fatigue. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progressive Multiple Sclerosis, Rehabilitation, Exercise