Study of Alternative Exercise Therapies for Progressive Multiple Sclerosis (MS)

NCT01097538 | Completed

• 1 other identifier: Hicks -MS exercise
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate a new therapy for patients with a severe form of MS known as progressive MS. These patients are severely limited in their ability to walk and function in everyday life. The exercise therapy we are proposing is a recumbent cross trainer which allows patients to be seated and move their arms and legs at the same time against resistive foot pedals and arm levers. The recumbent cross trainer is safe and easy to use for people with disabilities and is more cost-effective compared with other rehabilitation equipment. Before the recumbent trainer can become part of mainstream MS therapy, it is important to determine if it is as effective as other exercise therapies in improving functional performance and quality of life. In this study we will compare the effects of the recumbent cross training with supported treadmill walking on functional and psychological outcomes. Further, since this is a new therapy for progressive MS patients, we also want to determine if it is safe and enjoyable to use. We hypothesize that recumbent stepper training will be safe and well-tolerated by progressive MS patients. Both training interventions will be beneficial in improving walking function and psychosocial outcomes. Recumbent stepper straining will likely have greater effects on upper extremity function, while supported treadmill walking will have greater effects on lower extremity function.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety

  Adverse effects will be monitored at each training session. Therapists will record patient experiences of muscle and joint pain, physical discomfort, excessive fatigue, overheating, chest pain, dizziness/nausea and any other adverse effects experience by the patients. If symptoms become severe patients will be asked to discontinue training and consult their physician immediately.

  baseline, 12 weeks (end of trial)

Secondary Outcomes (6)

• Expanded Disability Status Scale (EDSS) -neurologic function

  baseline, 12 weeks (end)

• Multiple Sclerosis Functional Composite (MSFC)-functional ability

  baseline, 12 weeks (end)

• Modified Fatigue Impact Scale (MFIS) -fatigue

  baseline, 12 weeks (end)

• Multiple Sclerosis Quality of Life-54 -quality of life questionnaire

  baseline, 12 weeks (end)

• Multiple Sclerosis Self-Efficacy Scale (MSSE) -ability to manage MS symptoms

  baseline, 12 weeks (end)

Study Arms (2)

Body-weight supported treadmill training

ACTIVE COMPARATOR

Supported treadmill walking

Other: Body-weight supported treadmill training

Total body recumbent stepper training

EXPERIMENTAL

Recumbent stepper exercise training

Other: Total body recumbent stepper 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

Total body recumbent stepper training OTHER

Patients will train using the Nustep T4 (TRS 4000) which is a recumbent cross trainer that provides a full body workout in a seated position. The Nustep trainer allows patients to achieve a natural stepping motion against graded loads with bilateral reciprocal movement of the arms. Recumbent training is safe and easily accessible for patients of all ability levels with a swivel chair to aid in patient transfers. Foot straps, leg stabilizers and hand stabilizers may be used for added control and proper body alignment.

Total body recumbent stepper 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 OR clinically definite SPMS as per the diagnostic criteria of McDonald et al for RRMS with slow gradual progression observed over 6 months, not due to deterioration from attacks alone
• Absence of a relapse in the previous 6 months
• Expanded disability status score 6.0-8.0 (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 during specified training times for the duration of 12 weeks
• Ability to follow training instructions

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 recumbent stepper training or supported treadmill training

Sponsors & Collaborators

• Hicks, Audrey, Ph.D.: lead

Study Sites (1)

Centre for Health Promotion and Rehabilitation, McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; 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; Behavior; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Audrey Hicks, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Lara Pilutti

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 1, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 12, 2011

Record last verified: 2011-08

Locations

CA (1)