- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05954195
Effect of High Intensity Interval Training in Patients With Multiple Sclerosis
July 12, 2023 updated by: Fatma Khaled Mohamed Abdelaziz, Cairo University
Effect of High Intensity Interval Training in Patients With Multiple Sclerosis: Systematic Review
In this study, we are aiming to systematically review the literature on the effect of HIIT on MS patients as improving physical performance, cognitive function, aerobic fitness and muscle strength.
This could help guide the development of standardized clinical guidelines and direct clinical decision making by the physical therapists whether to implement this type of exercises or not.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Multiple sclerosis patients have considerably negative effects on the community and the national and international economy.
Chronic symptoms of MS such as fatigue, cognitive impairments, emotional burden and diminished physical functioning considerably affect the daily lives of people with MS and may interfere with social and quality of life factors as friendships, family relationships and occupational status.
HIIT has induced significant improvements in physiological conditioning in healthy and clinical populations, and might be appropriate for persons with MS.
Recently, several RCTs have been published evaluating the effect of HIIT on MS patients.
Consequently, this study will systematically review all these recent literature to direct the physiotherapists whether to implement this type of exercises or not.
Study Type
Interventional
Enrollment (Estimated)
86
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 Contact
- Name: Fatma Khaled M. Abdelaziz, Master
- Phone Number: +2001006196295
- Email: fabdelaziz@horus.edu.eg
Study Contact Backup
- Name: Hossam M. Elsaid, lecturer
Study Locations
-
-
-
Damietta, Egypt, 34724
- Recruiting
- Azzarqa
-
Contact:
- Fatma Khaled M. Abdelaziz, Master
- Phone Number: +2001006196295
- Email: fabdelaziz@horus.edu.eg
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Studies: English full texts of RCTs only, Participants: multiple sclerosis patients with age from (20-50) years old irrespectively of sex, subtype of MS, race, diagnostic criteria, community or onset of the disease, Intervention: HIIT, any comparator.
Exclusion Criteria:
- Studies other than English full text RCTs, non adults younger than 20 years and older than 50 years, populations other than multiple sclerosis.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: HIIT group
The group who received high intensity interval training
|
high intensity interval training through ergometer, with whole treatment session between 20 - 30 minutes divided into 3 parts, the 1st is warming up (40% of HRmax intensity for 2/3/5 minutes then the active training part (intervals of 85-90% of HRmax for 1 minute then rest period of 1 minute of 40 % of HRmax and so on for nearly 20 minutes ) then the last part is cooling down (30 % of HRmax for 3/5 minutes).
Other Names:
|
|
Placebo Comparator: control/comparator group
control group that might be placebo group, standard care group or no intervention group
|
high intensity interval training through ergometer, with whole treatment session between 20 - 30 minutes divided into 3 parts, the 1st is warming up (40% of HRmax intensity for 2/3/5 minutes then the active training part (intervals of 85-90% of HRmax for 1 minute then rest period of 1 minute of 40 % of HRmax and so on for nearly 20 minutes ) then the last part is cooling down (30 % of HRmax for 3/5 minutes).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cognitive function
Time Frame: 8-12 weeks or less
|
serum levels of serotonin and brain derived necrotic factor (BDNF)
|
8-12 weeks or less
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mental processing speed
Time Frame: 8-12 weeks or less
|
symbol digit modalities test
|
8-12 weeks or less
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Abeer Abobakr Dr Alwishy, Professor, Physical therapy for neuromuscular disorders and its surgeries, Cairo university
- Study Chair: Neveen Mohy-Eldin shalaby, professor, Faculty of medicine, Alqasr elainy, Cairo university
- Study Chair: Hossam M. Elsaid, lecturer, Faculty of physical therapy of neuromuscloskeletal disorders and its surgeries, Cairo universities
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zimmer P, Bloch W, Schenk A, Oberste M, Riedel S, Kool J, Langdon D, Dalgas U, Kesselring J, Bansi J. High-intensity interval exercise improves cognitive performance and reduces matrix metalloproteinases-2 serum levels in persons with multiple sclerosis: A randomized controlled trial. Mult Scler. 2018 Oct;24(12):1635-1644. doi: 10.1177/1352458517728342. Epub 2017 Aug 21.
- Langeskov-Christensen M, Grondahl Hvid L, Nygaard MKE, Ringgaard S, Jensen HB, Nielsen HH, Petersen T, Stenager E, Eskildsen SF, Dalgas U. Efficacy of High-Intensity Aerobic Exercise on Brain MRI Measures in Multiple Sclerosis. Neurology. 2021 Jan 12;96(2):e203-e213. doi: 10.1212/WNL.0000000000011241. Epub 2020 Dec 1.
- Spaas J, Goulding RP, Keytsman C, Fonteyn L, van Horssen J, Jaspers RT, Eijnde BO, Wust RCI. Altered muscle oxidative phenotype impairs exercise tolerance but does not improve after exercise training in multiple sclerosis. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2537-2550. doi: 10.1002/jcsm.13050. Epub 2022 Aug 4.
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 (Estimated)
July 20, 2023
Primary Completion (Estimated)
November 30, 2023
Study Completion (Estimated)
December 18, 2023
Study Registration Dates
First Submitted
July 12, 2023
First Submitted That Met QC Criteria
July 12, 2023
First Posted (Actual)
July 20, 2023
Study Record Updates
Last Update Posted (Actual)
July 20, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIIT in MS patients
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
a protocol about the effect of high intensity interval training in patients with multiple sclerosis: systematic review
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.