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

October 24, 2017 updated by: Evan Campbell, University of Glasgow
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 8LL
        • The University of Glasgow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
1.5 min intervals at 80-95% heart rate max on cycle ergometer 1.5 min intervals at nominal resistance on cycle ergometer
Active Comparator: control
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
20 min at 60-70% heart rate max on cycle ergometer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Collaborators

NHS Ayrshire and Arran
AKM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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