Supported Treadmill Training for Progressive Multiple Sclerosis

Body-weight Supported Treadmill Training in Primary Progressive Multiple Sclerosis: A Pilot Trial

CompletedNot a drug-phase studyProgressive MSNCT01339234

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Body-weight supported treadmill training

What it measured

Main measures

  • Change from baseline in Multiple Sclerosis Functional Composite (MSFC) at 12, 24 and 36 weeks

    Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

    Disability progressionThinking and memoryWalking and mobilityPhysical function

Other measures (5)

  • Change from baseline in Expanded Disability Status Scale (EDSS) at 12, 24 and 36 weeks

    Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

    Disability progression

  • Change from baseline in Modified Fatigue Impact Scale (MFIS) at 12, 24 and 36 weeks

    Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

    Thinking and memoryFatigue

  • Change from baseline in Multiple Sclerosis Quality of Life-54 questionnaire at 12, 24 and 36 weeks

    Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

    Quality of life (reported by participants)

  • Change from baseline in brain-derived neurotrophic factor (BDNF) at 12, 24 and 36 weeks

    Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

  • Change from baseline in magnetic resonance imaging (MRI) outcomes at 24 weeks

    Repeat assessments: baseline and 24 weeks

    MRI lesionsPhysical function

Who could take part

Progressive MS · 18 to 60

Show the full criteria

Inclusion criteria

* Signed, written informed consent * Males or non-pregnant females, 18-60 years of age (inclusive) * Clinically definite PPMS as per the diagnostic criteria of Thompson et al (2000) * Expanded disability status score 5.0-8.0 (constant assistance required) * Body weight \<90kg (due to support limitations of treadmill) * Approval from physician to participate in the exercise program * Ability to tolerate upright locomotion of the body weight supported treadmill * Ability to visit the different sites required for the study * Ability to commit to 3 weekly training sessions for the duration of 24 weeks

Exclusion criteria

* Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS * Any other serious medical condition that might impair the subject's ability to walk on a treadmill and/or participate in aerobic exercise (including but not limited to: documented heart disease or unstable angina, uncontrolled cardiac dysrhythmia, chronic obstructive lung disease, recent non-traumatic fracture, osteoporosis and severe skin ulcerations) * Female patients who do not agree to use effective contraceptive method(s) during the study * Current use or use within the last 2 months of any on- or off-label disease-modifying therapy including IFN-β, glatiramer acetate, IV steroids, mitoxantrone, azathioprine, and cyclophosphamide * Previous experience with supported treadmill training * Kidney disease, peripheral vascular disease or poor circulation * Inability to undergo MRI or MRI with gadolinium administration

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

About this trial

In the sponsor's words

This study is a pilot trial to evaluate the effects of supported treadmill walking in patients with primary progressive multiple sclerosis (MS) on functional and psychosocial outcomes. Patients will exercise three times per week over the course of 6 months and will be evaluated at baseline, 12 weeks and 24 weeks into the program. Follow-up testing will also be conducted 12 weeks after participants have stopped exercising to determined the lasting effects of the intervention. The investigators hypothesize that supported treadmill walking will be effective at improving physical physical function and psychosocial outcomes in patients with primary progressive MS.

Papers

Loading reviews and guidelines…

History

    1. Started

      Apr 2008

    2. Main results due

      Jun 2009

    3. Finished

      Jun 2009

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