High Intensity Interval Training for People With Mild Multiple Sclerosis: A Feasibility Study

NCT02702804 | Completed

• 1 other identifier: STH18899
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Physical fitness

  baseline and at 6 weeks which is study completion

• Impact of treatment intervention on multiple sclerosis

  baseline and at 6 weeks which is study completion

• Impact of treatment intervention on multiple sclerosis

  baseline and at 6 weeks which is study completion

Study Arms (1)

High Intensity Interval Training

EXPERIMENTAL

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

Interventions

High Intensity Interval Training OTHER

High Intensity Interval Training

High Intensity Interval Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Sheffield Hallam University: collaborator

Study Sites (2)

Sheffield Hallam University

Sheffield, South Yorkshire, S10 2BP, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Basil Sharrack, Professor

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 9, 2016
• Study Start: April 21, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 8, 2017
• Last Updated: November 14, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)