Clinical trial NCT02950454: The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.
Official title: The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Progressive
Keywords: Progressive Multiple Sclerosis
Rehabilitation
Exercise
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: NHS Ayrshire and Arran
name: AKM
First posted: 2016-11-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: heart rate max
timeFrame: 8 weeks
Secondary outcomes:
measure: Resting blood pressure
timeFrame: 8 weeks
measure: Resting heart rate
timeFrame: 8 weeks
measure: Brain derived neurotrophic factor
timeFrame: 8 weeks
measure: Lactate
timeFrame: 8 weeks
measure: Lipoprotein profile
timeFrame: 8 weeks
measure: MSIS-29 version 2
timeFrame: 8 weeks
measure: Hospital anxiety and depression scale
timeFrame: 8 weeks
measure: Timed 25 foot walk test
timeFrame: 8 weeks
measure: Symbol digit modalities test
timeFrame: 8 weeks
measure: Fatigue severity scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: The University of Glasgow
Study officials:
References: