Multiple Sclerosis Clinical Trial
— HIIT-MSOfficial title:
High Intensity Interval Training for People With Mild Multiple Sclerosis: A Feasibility Study
Verified date | August 2018 |
Source | Sheffield Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Exercise has been shown to improve quality of life in people with multiple sclerosis but most
exercise programmes are carried out at low to moderate intensities. The next stage in the
management of the condition is to establish if people with mild Multiple Sclerosis can
exercise, safely and effectively at a higher intensity. High intensity interval training
(HIIT) involves repeated bursts of hard exercise interspersed with periods of rest. High
intensity interval trainingcould be a time efficient and safe option for people with Multiple
Sclerosis. Potential improvements are; cardiovascular fitness, resistance to fatigue,
balance, quality of life and attitude to physical exercise.
Participants will attend two sessions per week for 6 weeks. Each session will involve 6-10
sets of 60 seconds of high intensity cycling followed by 60 seconds rest. Potential
participants must have a clinical diagnosis of Mulitple Sclerosis for more than 3 months, an
EDSS score of less than 2.5, aged 18-65, and had no more than one relapse in the last 2
years.
From this study the investigators hope to discover if High Intensity Interval Training is a
safe and enjoyable form of physical activity for people with mild Multiple Sclerosis. This
will then hopefully lead to further large research trials.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 8, 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Clinical Diagnosis of MS more than three months - EDSS score of less than 2.5 - Aged 18-65 - No more than one relapse in the last 2 years - Participants on disease modifying therapy (Interferon and Grateramer Acetate) must have been stable on this treatment for at least 3 months prior to entering the study Exclusion Criteria: - Failure to meet any of the inclusion criteria - Experiencing illness or injury that impairs their ability to be physically active - Living more than 20 miles away from Centre for Sport and Exercise Science |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Hallamshire Hospital | Sheffield | |
United Kingdom | Sheffield Hallam University | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield Hallam University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants recruited to the study who adhere to high intensity interval training intervention | Adherence will be measured through attendance to the exercise sessions and compliance to the prescribed intensity | 12 months | |
Primary | Number of participants with treatment related adverse events as recorded by the research team | The research team will complete an adverse event form after each session, stating whether any adverse events occurred or not. For additional safety monitoring participants will be given a diary to record how they feel immediately after the exercise session, several hours after and the next day. | 12 months | |
Secondary | Physical fitness | changes to physical fitness will be measured using the VO2peak cycle ergometer test | baseline and at 6 weeks which is study completion | |
Secondary | Impact of treatment intervention on multiple sclerosis | Number of Participants with Adverse Events That Are Related to Treatment intervention | baseline and at 6 weeks which is study completion | |
Secondary | Impact of treatment intervention on multiple sclerosis | Number of participants who record changes on the quality of life questions due to the impact of treatment | baseline and at 6 weeks which is study completion |
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