The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.
Primary Purpose
Multiple Sclerosis, Progressive
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High intensity interval training
Continuous moderate exercise
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Progressive focused on measuring Progressive Multiple Sclerosis, Rehabilitation, Exercise
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.
Sites / Locations
- The University of Glasgow
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
heart rate max
Maximal heart rate elicited during a maximal exertion test
Secondary Outcome Measures
Resting blood pressure
Resting heart rate
Brain derived neurotrophic factor
Hormone important for brain growth and protection
Lactate
Waste materials from exercise in blood
Lipoprotein profile
Indication of how much good and how much bad cholesterol is in blood
MSIS-29 version 2
Questionnaire giving physical and psychological impact of MS
Hospital anxiety and depression scale
Questionnaire giving a score of depression and anxiety
Timed 25 foot walk test
Measure of walking speed
Symbol digit modalities test
Measure of mental processing speed
Fatigue severity scale
Questionnaire which gives measure of fatigue.
Full Information
NCT ID
NCT02950454
First Posted
October 28, 2016
Last Updated
October 24, 2017
Sponsor
University of Glasgow
Collaborators
NHS Ayrshire and Arran, AKM
1. Study Identification
Unique Protocol Identification Number
NCT02950454
Brief Title
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
NHS Ayrshire and Arran, AKM
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Progressive
Keywords
Progressive Multiple Sclerosis, Rehabilitation, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
1.5 min intervals at 80-95% heart rate max on cycle ergometer 1.5 min intervals at nominal resistance on cycle ergometer
Intervention Type
Other
Intervention Name(s)
Continuous moderate exercise
Intervention Description
20 min at 60-70% heart rate max on cycle ergometer
Primary Outcome Measure Information:
Title
heart rate max
Description
Maximal heart rate elicited during a maximal exertion test
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Resting blood pressure
Time Frame
8 weeks
Title
Resting heart rate
Time Frame
8 weeks
Title
Brain derived neurotrophic factor
Description
Hormone important for brain growth and protection
Time Frame
8 weeks
Title
Lactate
Description
Waste materials from exercise in blood
Time Frame
8 weeks
Title
Lipoprotein profile
Description
Indication of how much good and how much bad cholesterol is in blood
Time Frame
8 weeks
Title
MSIS-29 version 2
Description
Questionnaire giving physical and psychological impact of MS
Time Frame
8 weeks
Title
Hospital anxiety and depression scale
Description
Questionnaire giving a score of depression and anxiety
Time Frame
8 weeks
Title
Timed 25 foot walk test
Description
Measure of walking speed
Time Frame
8 weeks
Title
Symbol digit modalities test
Description
Measure of mental processing speed
Time Frame
8 weeks
Title
Fatigue severity scale
Description
Questionnaire which gives measure of fatigue.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
The University of Glasgow
City
Glasgow
ZIP/Postal Code
G12 8LL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.
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