Exercise Training for People With Advanced Multiple Sclerosis

Exercise Training for People With Advanced Multiple Sclerosis: A Feasibility Study to Inform Intervention Development

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07546721

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Aerobic Exercise Training

What it measured

Main measures

  • Feasibility - Recruitment duration

    Ongoing during the study recruitment period.

    Feasibility

  • Feasibility - Recruitment methods

    Ongoing during the study recruitment period.

    Feasibility

  • Feasibility - Recruitment screening time

    Ongoing during the study recruitment period.

    Feasibility

  • Feasibility - Recruitment eligibility rate

    Ongoing during the study recruitment period.

    Feasibility

  • Feasibility - Recruitment exclusion reasons

    Ongoing during the study recruitment period.

    Feasibility

  • Feasibility - Adherence

    Ongoing during the 12-week intervention.

    Quality of life (reported by participants)Feasibility

  • Feasibility - Compliance frequency

    Ongoing during the 12-week intervention.

    Physical functionFeasibility

  • Feasibility - Compliance duration

    Ongoing during the 12-week intervention.

    Physical functionFeasibility

  • Feasibility - Compliance intensity

    Ongoing during the 12-week intervention.

    Physical functionFeasibility

  • Feasibility - Attrition frequency

    Over the course of the 24-week study period.

    Feasibility

  • Feasibility - Attrition reasons

    Over the course of the 24-week study period.

    Feasibility

  • Feasibility - Time required for testing sessions

    At each testing timepoint (Baseline, 6, 12, and 24 weeks).

    Feasibility

  • Feasibility - Time required for training sessions

    Ongoing during the 12-week intervention.

    Feasibility

  • Feasibility - Personnel required

    Over the course of the 24-week study period.

    Feasibility

  • Feasibility - Personnel training completed

    Before delivery of the 12-week intervention.

    Feasibility

  • Feasibility - Time required for research ethics approval

    Before the start of the trial.

    Feasibility

  • Feasibility - Adverse events

    Over the course of the 24-week study period (recorded at each testing and training session).

    SafetyFeasibility

  • Feasibility - Acceptability of equipment

    After the 12-week intervention.

    Physical functionFeasibility

  • Feasibility - Acceptability of outcomes

    At each testing timepoint (Baseline, 6, 12 and 24 weeks).

    Feasibility

Other measures (11)

  • Cardiorespiratory fitness

    Baseline and 12 weeks

    Physical function

  • Sensory function

    Baseline, 6, 12 and 24 weeks

    Disability progressionFatigue

  • Function in daily life

    Baseline, 6, 12 and 24 weeks

  • Physical function with a mobility aid

    Baseline, 6, 12 and 24 weeks

    Walking and mobilityQuality of life (reported by participants)

  • Self-efficacy for managing chronic conditions

    Baseline, 6, 12 and 24 weeks

    Quality of life (reported by participants)

  • Symptoms of fatigue

    Baseline, 6, 12 and 24 weeks

    Fatigue

  • Symptoms of pain

    Baseline, 6, 12 and 24 weeks

    Pain

  • Cognitive performance

    Baseline, 6, 12 and 24 weeks

    Thinking and memory

  • Cognitive performance

    Baseline and 12 weeks

    Thinking and memory

  • Participant experiences of the intervention

    After the 12-week intervention.

    Physical function

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* ≥18 years of age * Self-reported diagnosis of MS * Expanded Disability Status Score ≥ 7.0 * Stable course of disease-modifying therapy over past six months * Physician approval for exercise participation

Exclusion criteria

* Diagnosis of other neurological conditions * Relapse within 30 days * Signs or symptoms of acute or uncontrolled cardiovascular, renal or metabolic disease or other conditions that make it unsafe to exercise * Currently engaging in regular aerobic exercise (≥ 2 sessions/week for ≥ 12 weeks) * Additional exclusion criteria for functional electrical stimulation (FES) cycling exercise are cardiac demand pacemakers, implanted defibrillators, unhealed fractures, pregnancy, epilepsy, autonomic dysreflexia, and acute infections

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

Contact details on the registry

About this trial

In the sponsor's words

The goal of this interventional study is to test the feasibility of 12 weeks of aerobic exercise for people with advanced multiple sclerosis (i.e., wheelchair users). The main questions it aims to answer are: * Is the exercise intervention feasible in terms of study processes, resources, management, safety, and acceptability? * Can the intervention improve aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, and sensation? * What are participants' experiences of taking part in the exercise intervention? Participants will take part in moderate-intensity aerobic exercise twice a week for 12 weeks in a supervised research setting. Outcomes will be measured at baseline (0 weeks), mid-intervention (6 weeks), post-intervention (12 weeks), and 12-weeks after the intervention (24 weeks). The outcomes include feasibility measures, aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, sensation, and participant experiences of taking part in the exercise intervention.

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History

    1. Started

      May 2026

    2. Main results due

      Mar 2027

    3. Finished

      Jun 2027

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