NCT07578740

Brief Summary

This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS). This randomized controlled trial will be conducted at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.

Trial Health

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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
23mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

May 5, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

Multiple Sclerosis, High-Intensity Interval Training, HIIT, Gait, Balance, Cognition, BDNF, VEGF, Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go Test (TUG)

    Timed Up and Go Test (TUG). Participants are asked to rise from a standard chair, walk 3 meters, turn around, walk back, and sit down as fast as safely possible. Measured in seconds. Lower values indicate better functional mobility and balance.

    Baseline and 8 weeks

Secondary Outcomes (10)

  • Timed 25-Foot Walk Test (T25FW)

    Baseline and 8 weeks

  • Dynamic Gait Index (DGI)

    Baseline and 8 weeks

  • Incremental Shuttle Walk Test (ISWT)

    Baseline and 8 weeks

  • Mini Balance Evaluation Systems Test (Mini-BESTest)

    Baseline and 8 weeks

  • Modified CTSIB (mCTSIB) - Static Posturography

    Baseline and 8 weeks

  • +5 more secondary outcomes

Study Arms (2)

MICT Group (Moderate-Intensity Continuous Training)

ACTIVE COMPARATOR

Cycle ergometer-based MICT, twice weekly for 8 weeks, starting at 60% of peak workload, progressing to 80%. Sessions include 5-min warm-up, 20-30 min exercise, 5-min cool-down, followed by 30-min individualized physiotherapy.

Behavioral: Moderate-Intensity Continuous Training (MICT)

HIIT Group (High-Intensity Interval Training)

EXPERIMENTAL

HIIT on cycle ergometer, twice weekly for 8 weeks. Protocol: 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each, followed by 5-min cool-down. Total session: \~20 min aerobic + 30-min individualized physiotherapy.

Behavioral: High-Intensity Interval Training (HIIT)

Interventions

Cycle ergometer-based exercise, twice weekly for 8 weeks. Starting intensity at 60% of peak workload, progressing to 80%. Each session includes 5-min warm-up, 20-30 min continuous exercise, and 5-min cool-down, followed by 30-min individualized physiotherapy program.

MICT Group (Moderate-Intensity Continuous Training)

Cycle ergometer-based exercise, twice weekly for 8 weeks. Each session includes 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each interval, and 5-min cool-down. Total aerobic exercise duration: \~20 min, followed by 30-min individualized physiotherapy program.

HIIT Group (High-Intensity Interval Training)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Multiple Sclerosis by a neurologist (Hacettepe University Hospitals, Neurology Outpatient Clinic)
  • Age 18 years and older
  • EDSS score between 0 and 4
  • Score of 24 or above on the Standardized Mini Mental State Examination
  • No relapse in the past 3 months
  • Medically stable for at least 6 months

You may not qualify if:

  • Any additional cardiopulmonary, neurological, or systemic disease other than MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

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

  • Yeliz SALCI

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra Turan, Msc, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate / Physiotherapist

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations