Supported Treadmill Training for Progressive Multiple Sclerosis

NCT01339234 | Completed

• 1 other identifier: Hicks -MS treadmill
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

treadmill exercise; rehabilitation; progressive multiple sclerosis; functional ability; quality of life; fatigue

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (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)

• 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)

• 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)

• 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

Study Arms (1)

Body-weight supported treadmill training

EXPERIMENTAL

Other: Body-weight supported treadmill training

Interventions

Body-weight supported treadmill training OTHER

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.

Body-weight supported treadmill training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hicks, Audrey, Ph.D.: lead
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

McMaster University (Centre for Health Promotion and Rehabilitation)/Hamilton Health Sciences

Hamilton, Ontario, L8S 4K1, Canada

Location

Related 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(1):31-6. doi: 10.1016/j.apmr.2010.08.027.

  PMID: 21187202 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Michel Rathbone, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Audrey Hicks, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 20, 2011
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 20, 2011

Record last verified: 2011-04

Locations

CA (1)