Effect of High Intensity Interval Training in Patients With Multiple Sclerosis

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05954195

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

17.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: high intensity interval training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 HRmaxhigh 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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Other

Official Title:

Effect of High Intensity Interval Training in Patients With Multiple Sclerosis: Systematic Review

Anticipated Study Start Date :

Jul 20, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 18, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HIIT group The group who received high intensity interval training	Other: 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: progressive aerobic training sprinting interval exercise
Placebo Comparator: control/comparator group control group that might be placebo group, standard care group or no intervention group	Other: 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: progressive aerobic training sprinting interval exercise

Arm

Intervention/Treatment

Active Comparator: HIIT group

The group who received high intensity interval training

Other: 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:

progressive aerobic training

sprinting interval exercise

Placebo Comparator: control/comparator group

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

Other: high intensity interval training

Other Names:

progressive aerobic training

sprinting interval exercise

Outcome Measures

Primary Outcome Measures

cognitive function [8-12 weeks or less]
serum levels of serotonin and brain derived necrotic factor (BDNF)

Secondary Outcome Measures

mental processing speed [8-12 weeks or less]
symbol digit modalities test

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azzarqa	Damietta		Egypt	34724

Sponsors and Collaborators

Cairo University

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatma Khaled Mohamed Abdelaziz, Fatma Khaled Mohamed Abdelaziz, Cairo University

ClinicalTrials.gov Identifier:

NCT05954195

Other Study ID Numbers:

HIIT in MS patients

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fatma Khaled Mohamed Abdelaziz, Fatma Khaled Mohamed Abdelaziz, Cairo University

Multiple sclerosis AND high intensity interval training

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Jul 20, 2023