Clinical trial NCT01339234: Supported Treadmill Training for Progressive Multiple Sclerosis
Official title: Body-weight Supported Treadmill Training in Primary Progressive Multiple Sclerosis: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: treadmill exercise
rehabilitation
progressive multiple sclerosis
functional ability
quality of life
fatigue
Lead sponsor: Hicks, Audrey, Ph.D.
Sponsor class: INDIV
Collaborators: name: Multiple Sclerosis Society of Canada
First posted: 2011-04-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: The use of exercise as an adjunct to other disease modifying treatments in MS has found increasing support over the past decade. There is ample evidence that exercise therapy can improve physical measures of disability in MS, in addition to being safe and well-tolerated. However, there is a paucity of data on whether exercise is equally effective for those with primary progressive MS as it is in relapsing remitting MS. In addition, studies of exercise therapy have traditionally excluded MS patients with severe disability. There are also currently no treatments for primary progressive MS, so finding a safe disease-modifying therapy is of the utmost importance. The investigators are therefore conducting a pilot trial to evaluate the effects of exercise in the form of supported treadmill walking for patients with primary progressive MS with severe functional impairments.

Six patients with primary progressive MS with high disability level will be recruited to participate in this study. Participants will exercise using body-weight supported treadmill training (BWSTT; Woodway Loco-system) which allows a portion of an individual's body-weight to be counterbalanced by an overhead pulley system. This system allows patients with limited mobility to walk upright on the treadmill with therapist assistance. Therapists trained in using the BWSTT system will guide the patients' legs through a proper gait motion and assist with lower limb control. Participants will complete 72 training sessions (30min/session, 3x/week) over the course of 24 weeks. Participants will be evaluated at baseline, 12 weeks (half-way through the training program) and 24 weeks (end of intervention). A follow-up assessment will also be performed 12 after participants have completed the training program (36 weeks). Outcome measures are described below.

Eligibility 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

Primary outcomes:
measure: Change from baseline in Multiple Sclerosis Functional Composite (MSFC) at 12, 24 and 36 weeks
timeFrame: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)
Secondary outcomes:
measure: Change from baseline in Expanded Disability Status Scale (EDSS) at 12, 24 and 36 weeks
timeFrame: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)
measure: Change from baseline in Modified Fatigue Impact Scale (MFIS) at 12, 24 and 36 weeks
timeFrame: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)
measure: Change from baseline in Multiple Sclerosis Quality of Life-54 questionnaire at 12, 24 and 36 weeks
timeFrame: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)
measure: Change from baseline in brain-derived neurotrophic factor (BDNF) at 12, 24 and 36 weeks
timeFrame: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)
measure: Change from baseline in magnetic resonance imaging (MRI) outcomes at 24 weeks
timeFrame: Repeat assessments: baseline and 24 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University (Centre for Health Promotion and Rehabilitation)/Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Michel Rathbone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Audrey Hicks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pilutti LA, Lelli DA, Paulseth JE, Crome M, Jiang S, Rathbone MP, Hicks AL. Effects of 12 weeks of supported treadmill training on functional ability and quality of life in progressive multiple sclerosis: a pilot study. Arch Phys Med Rehabil. 2011 Jan;92(1):31-6. doi: 10.1016/j.apmr.2010.08.027.