NCT05954195

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 12, 2023

Last Update Submit

July 12, 2023

Conditions

Keywords

Multiple sclerosis AND high intensity interval training

Outcome Measures

Primary Outcomes (1)

  • cognitive function

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

    8-12 weeks or less

Secondary Outcomes (1)

  • mental processing speed

    8-12 weeks or less

Study Arms (2)

HIIT group

ACTIVE COMPARATOR

The group who received high intensity interval training

Other: high intensity interval training

control/comparator group

PLACEBO COMPARATOR

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

Other: high intensity interval training

Interventions

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).

Also known as: progressive aerobic training, sprinting interval exercise
HIIT groupcontrol/comparator group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Studies other than English full text RCTs, non adults younger than 20 years and older than 50 years, populations other than multiple sclerosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azzarqa

Damietta, 34724, Egypt

RECRUITING

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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 CHAIR

Central Study Contacts

Fatma Khaled M. Abdelaziz, master

CONTACT

Hossam M. Elsaid, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fatma Khaled Mohamed Abdelaziz

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 20, 2023

Study Start

July 20, 2023

Primary Completion

November 30, 2023

Study Completion

December 18, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations