Effects of a Resistance Training Program on Immunological, Psychological, and Functional Indicators in People With Multiple Sclerosis: A Randomized Clinical Trial

CompletedNot a drug-phase studyMS (type not specified)NCT07118514

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 22 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Progressive Resistance Training

Compared with

  • Stretching and Relaxation Activities

What it measured

Main measures

  • Plasma levels of cortisol, brain-derived neurotrophic factor (BDNF), and irisin.

    - Baseline - 12 weeks

    How the body handles the medicine

Other measures (11)

  • Muscle Strength (Dynamic and Isokinetic)

    - Baseline - 12 weeks

    Arm and hand functionPhysical function
  • Functional Mobility

    - Baseline - 12 weeks

    Walking and mobility
  • Isokinetic Muscle Strength (Lower Limbs)

    - Baseline -12 weeks

    Physical function
  • Fatigue

    - Baseline -12 weeks

    Fatigue
  • Anxiety and Depression

    - Baseline -12 weeks

    Mood and sleep
  • Health-Related Quality of Life

    - Baseline - 12 weeks.

    Quality of life (reported by participants)
  • Optimism

    - Baseline - 12 weeks.

  • Perceived Barriers to Physical Activity

    - Baseline .

    Physical function
  • Physical Activity Level

    - Baseline

    Physical function
  • Motivation for Exercise

    - Baseline

    Physical function

Who could take part

MS (type not specified) · EDSS 1.0 to 6.0

Show the full criteria

Inclusion criteria

* Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2017 McDonald Criteria * Expanded Disability Status Scale (EDSS) score between 1.0 and 6.0 * Age between 18 and 60 years * Medical clearance to engage in physical exercise * Ability to understand and provide written informed consent * Stable pharmacological treatment for MS for at least 3 months prior to enrollment * No MS relapses or corticosteroid use within 30 days before starting the intervention

Exclusion criteria

* Pregnancy or planning to become pregnant during the study period * Severe musculoskeletal conditions contraindicating exercise * Participation in another structured or systematic exercise program * Visual, cognitive, or communication impairments that may hinder participation * Use of orthopedic devices incompatible with the intervention protocols * Any other condition that, in the opinion of the research team, may interfere with participation or compromise data integrity

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This randomized controlled trial aims to investigate the effects of a supervised resistance training program on plasma levels of Brain-Derived Neurotrophic Factor (BDNF) and irisin in individuals diagnosed with multiple sclerosis (MS). The study will also examine secondary outcomes, including fatigue, quality of life, anxiety and depression symptoms, muscular strength, and functional capacity. Participants will be randomly assigned to either an intervention or control group in a 2:1 allocation ratio. The intervention group will undergo a 12-week supervised resistance training program, while the control group will maintain their usual care without engaging in any structured exercise regimen. The trial will be non-blinded and involve assessments at baseline and after the 12-week intervention period. Eligible participants must be adults (≥18 years), of any sex, with a confirmed diagnosis of MS by a neurologist, and currently undergoing disease-modifying therapy (DMT). Participants must not be engaged in any other structured physical exercise program, though symptom-management physiotherapy will be permitted. All participants should have sufficient mobility to complete the training sessions and assessments. Exclusion criteria include the inability to perform the physical training or functional tests due to severe mobility restrictions, lack of standard pharmacological treatment for MS, or concurrent participation in other structured exercise programs.

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History

    1. Started

      Aug 2024

    2. Main results due

      Dec 2024

    3. Finished

      Dec 2024

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