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Effect of High Intensity Interval Training in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high intensity interval training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple sclerosis AND high intensity interval training

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AzzarqaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HIIT group

control/comparator group

Arm Description

The group who received high intensity interval training

control group that might be placebo group, standard care group or no intervention group

Outcomes

Primary Outcome Measures

cognitive function
serum levels of serotonin and brain derived necrotic factor (BDNF)

Secondary Outcome Measures

mental processing speed
symbol digit modalities test

Full Information

First Posted
July 12, 2023
Last Updated
July 12, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05954195
Brief Title
Effect of High Intensity Interval Training in Patients With Multiple Sclerosis
Official Title
Effect of High Intensity Interval Training in Patients With Multiple Sclerosis: Systematic Review
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis AND high intensity interval training

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
high intensity interval training starting by warm up period of 40 % from the HRmax then the interval exercise period of 85-90 % from HRmax ending by cool down period from 30 % of HRmax
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
the studies mask the participants and they randomly divided into 2 groups then the care provider is masked too not to choose specific participant for specific intervention then the outcome assessor is masked to document the outcomes with fair then the investigator is masked too to document results honestly without being motivated towards the intervention.
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIIT group
Arm Type
Active Comparator
Arm Description
The group who received high intensity interval training
Arm Title
control/comparator group
Arm Type
Placebo Comparator
Arm Description
control group that might be placebo group, standard care group or no intervention group
Intervention Type
Other
Intervention Name(s)
high intensity interval training
Other Intervention Name(s)
progressive aerobic training, sprinting interval exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
cognitive function
Description
serum levels of serotonin and brain derived necrotic factor (BDNF)
Time Frame
8-12 weeks or less
Secondary Outcome Measure Information:
Title
mental processing speed
Description
symbol digit modalities test
Time Frame
8-12 weeks or less

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Khaled M. Abdelaziz, master
Phone
+2001006196295
Email
fabdelaziz@horus.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hossam M. Elsaid, lecturer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer Abobakr Dr Alwishy, Professor
Organizational Affiliation
Physical therapy for neuromuscular disorders and its surgeries, Cairo university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neveen Mohy-Eldin shalaby, professor
Organizational Affiliation
Faculty of medicine, Alqasr elainy, Cairo university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hossam M. Elsaid, lecturer
Organizational Affiliation
Faculty of physical therapy of neuromuscloskeletal disorders and its surgeries, Cairo universities
Official's Role
Study Chair
Facility Information:
Facility Name
Azzarqa
City
Damietta
ZIP/Postal Code
34724
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Khaled M. Abdelaziz, Master
Phone
+2001006196295
Email
fabdelaziz@horus.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
a protocol about the effect of high intensity interval training in patients with multiple sclerosis: systematic review
Citations:
PubMed Identifier
28825348
Citation
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.
Results Reference
result
PubMed Identifier
33262230
Citation
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.
Results Reference
result
PubMed Identifier
35929063
Citation
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.
Results Reference
result

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Effect of High Intensity Interval Training in Patients With Multiple Sclerosis

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