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Completed

NCT Number: NCT02950454

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

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.

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Key information

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training

Other

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 exercise

Other

20 min at 60-70% heart rate max on cycle ergometer

Primary outcomes

  1. heart rate max

    Time frame: 8 weeks

    Maximal heart rate elicited during a maximal exertion test

Secondary outcomes

  1. Resting blood pressure

    Time frame: 8 weeks

  2. Resting heart rate

    Time frame: 8 weeks

  3. Brain derived neurotrophic factor

    Time frame: 8 weeks

    Hormone important for brain growth and protection

  4. Lactate

    Time frame: 8 weeks

    Waste materials from exercise in blood

  5. Lipoprotein profile

    Time frame: 8 weeks

    Indication of how much good and how much bad cholesterol is in blood

  6. MSIS-29 version 2

    Time frame: 8 weeks

    Questionnaire giving physical and psychological impact of MS

  7. Hospital anxiety and depression scale

    Time frame: 8 weeks

    Questionnaire giving a score of depression and anxiety

  8. Timed 25 foot walk test

    Time frame: 8 weeks

    Measure of walking speed

  9. Symbol digit modalities test

    Time frame: 8 weeks

    Measure of mental processing speed

  10. Fatigue severity scale

    Time frame: 8 weeks

    Questionnaire which gives measure of fatigue.

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • AKM
  • NHS Ayrshire and Arran

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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