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

NCT02950454 | Completed

• 1 other identifier: 1.0
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Progressive

Keywords

Progressive Multiple Sclerosis; Rehabilitation; Exercise

Outcome Measures

Primary Outcomes (1)

• heart rate max

  Maximal heart rate elicited during a maximal exertion test

  8 weeks

Secondary Outcomes (10)

• Resting blood pressure

  8 weeks

• Resting heart rate

  8 weeks

• Brain derived neurotrophic factor

  8 weeks

• Lactate

  8 weeks

• Lipoprotein profile

  8 weeks

Study Arms (2)

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.

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.

Other: Continuous moderate exercise

Interventions

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

Intervention

Continuous moderate exercise OTHER

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

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead
• NHS Ayrshire and Arran: collaborator
• AKM: collaborator

Study Sites (1)

The University of Glasgow

Glasgow, G12 8LL, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)