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Not yet recruiting NCT07578740

The Effects of High-Intensity Interval Training on Gait, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis

No phase Interventional Multiple Sclerosis High-intensity Interval Training Gait Balance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Moderate-Intensity Continuous Training (MICT), High-Intensity Interval Training (HIIT).
Who it may be relevant to
Registry conditions: Multiple Sclerosis, High-intensity Interval Training, Gait, Balance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Investigating the Effects of High-Intensity Interval Training on Gait, Balance, and Cognition in Individuals With Multiple Sclerosis

Overview

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.

Detailed description

Individuals with MS aged 18 and older, with an EDSS score of 0-4, no relapse in the past three months, and medically stable condition will be randomized into two groups using a sealed-envelope method. Group 1 will receive MICT on a cycle ergometer (twice weekly, 8 weeks); Group 2 will receive low-volume HIIT with the same frequency. Both groups will receive an individualized physiotherapy program after each aerobic session. Outcomes include gait (TUG, T25FW, DGI), balance (Mini-BESTest, mCTSIB), cognitive function (BICAMS: SDMT, CVLT-II, BVMT-R), exercise capacity (ISWT), and blood biomarkers (BDNF, VEGF) assessed via ELISA.

Interventions

  • Behavioral Moderate-Intensity Continuous Training (MICT)
    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.
  • Behavioral High-Intensity Interval Training (HIIT)
    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.

Primary outcome measures

  • Timed Up and Go Test (TUG) [Time frame: Baseline and 8 weeks]
Secondary outcome measures (10)
  • Timed 25-Foot Walk Test (T25FW) [Time frame: Baseline and 8 weeks]
  • Dynamic Gait Index (DGI) [Time frame: Baseline and 8 weeks]
  • Incremental Shuttle Walk Test (ISWT) [Time frame: Baseline and 8 weeks]
  • Mini Balance Evaluation Systems Test (Mini-BESTest) [Time frame: Baseline and 8 weeks]
  • Modified CTSIB (mCTSIB) - Static Posturography [Time frame: Baseline and 8 weeks]
  • Serum BDNF levels (ELISA) [Time frame: Baseline and 8 weeks]
  • Serum VEGF levels (ELISA) [Time frame: Baseline and 8 weeks]
  • Symbol Digit Modalities Test (SDMT) [Time frame: Baseline and 8 weeks]
  • California Verbal Learning Test-II (CVLT-II) [Time frame: Baseline and 8 weeks]
  • Brief Visuospatial Memory Test-Revised (BVMT-R) [Time frame: Baseline and 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University — Ankara

Identifiers

NCT: NCT07578740 · FTREK26/19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗