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High Intensity Interval Training for People With Mild Multiple Sclerosis: A Feasibility Study (HIIT-MS)

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ClinicalTrials.gov Identifier: NCT02702804
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Sheffield Hallam University
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: High Intensity Interval Training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Interval Training for People With Mild Multiple Sclerosis: A Feasibility Study
Actual Study Start Date : February 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Training
Participants will attend two sessions per week for the 6 week intervention. Each session will consist of 6-10 sets of 60 second high intensity intervals interspersed with 60 seconds recovery. The workload during each interval will be set at 80-90% of peak power achieved during the VO2peak test. This is predicted to elicit 85-95% heart rate reserve in the participants. After each interval the participant's heart rate and rate of perceived exertion (RPE) will be collected. After each session a researcher will complete an Adverse Event form to record if an event occurred or not. Additionally the participant will complete a physical activity enjoyment (Perceived activity enjoyment scale) after one session per week.
Other: High Intensity Interval Training
High Intensity Interval Training




Primary Outcome Measures :
  1. Number of participants recruited to the study who adhere to high intensity interval training intervention [ Time Frame: 12 months ]
    Adherence will be measured through attendance to the exercise sessions and compliance to the prescribed intensity

  2. Number of participants with treatment related adverse events as recorded by the research team [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Physical fitness [ Time Frame: baseline and at 6 weeks which is study completion ]
    changes to physical fitness will be measured using the VO2peak cycle ergometer test

  2. Impact of treatment intervention on multiple sclerosis [ Time Frame: baseline and at 6 weeks which is study completion ]
    Number of Participants with Adverse Events That Are Related to Treatment intervention

  3. Impact of treatment intervention on multiple sclerosis [ Time Frame: baseline and at 6 weeks which is study completion ]
    Number of participants who record changes on the quality of life questions due to the impact of treatment



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702804


Locations
United Kingdom
Sheffield Hallam University
Sheffield, South Yorkshire, United Kingdom, S10 2BP
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
Investigators
Principal Investigator: Basil Sharrack, Professor Sheffield Teaching Hospitals NHS FT

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02702804     History of Changes
Other Study ID Numbers: STH18899
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases