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

Multiple Sclerosis, Progressive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950454
• Other study ID #: 1.0
• Status: Completed
• Phase: N/A
• First received: October 28, 2016
• Last updated: October 24, 2017
• Start date: January 2017
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Progressive
• Sclerosis

Intervention

Other:
• High intensity interval training
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
20 min at 60-70% heart rate max on cycle ergometer

Locations

Country	Name	City	State
United Kingdom	The University of Glasgow	Glasgow

Sponsors (3)

Lead Sponsor	Collaborator
University of Glasgow	AKM Stats, NHS Ayrshire & Arran

Country where clinical trial is conducted

United Kingdom, 

Outcome

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