Supported Treadmill Training for Progressive Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339234
• Other study ID #: Hicks -MS treadmill
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: April 19, 2011
• Start date: April 2008
• Est. completion date: June 2009

Study information

• Verified date: April 2011
• Source: Hicks, Audrey, Ph.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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-ß, 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Body-weight supported treadmill training
Patients will undergo training using the Woodway Loco-system which consists of a treadmill with an overhead pulley system connected to a support harness. BWSTT allows patients with limited mobility to safely walk upright on a treadmill with a portion of their body weight counter balanced. Three trainers will be required to assist with the BWSTT program. Two trainers will be positioned at the lower limbs to manually guide the participant through a proper gait motion and provided lower limb control. A third trainer will stand behind the participant to provide trunk support and assist with weight shifting.

Locations

Country	Name	City	State
Canada	McMaster University (Centre for Health Promotion and Rehabilitation)/Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hicks, Audrey, Ph.D.	Multiple Sclerosis Society of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Multiple Sclerosis Functional Composite (MSFC) at 12, 24 and 36 weeks	The MSFC assesses functional ability with three scales: the 25ft walk (leg strength and ambulation), the 9-hole peg test (arm strength and coordination) and the Paced Auditory Serial Addition Test (PASAT; cognition). Scores on all three measures are combined to produce a composite Z-score.	Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)	No
Secondary	Change from baseline in Expanded Disability Status Scale (EDSS) at 12, 24 and 36 weeks	The EDSS provides a measure of physical and neurological function specifically in MS patients and is scored from 0-10. This will be assessed by a train neurologist.	Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)	No
Secondary	Change from baseline in Modified Fatigue Impact Scale (MFIS) at 12, 24 and 36 weeks	The MFIS is a 21-item self-report questionnaire that evaluates fatigue overall fatigue, as well as within three categories: physical (pMFIS); cognitive (cMFIS); and psychosocial (psMFIS), over the previous 4 weeks. Scores range from 0-4 on each item with a maximum total score of 84, where higher scores indicate greater fatigue levels.	Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)	No
Secondary	Change from baseline in Multiple Sclerosis Quality of Life-54 questionnaire at 12, 24 and 36 weeks	The MSQOL-54 is an MS-specific measure of quality of life that consists of 54 items divided into 12 multi-item scales, 2 single-item scales, and 2 composite scores (physical and mental health).	Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)	No
Secondary	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)	No
Secondary	Change from baseline in magnetic resonance imaging (MRI) outcomes at 24 weeks	Both standard and unconventional MRI techniques will be used to evaluate the effects of exercise on brain health.	Repeat assessments: baseline and 24 weeks	No