Study of Alternative Exercise Therapies for Progressive Multiple Scler
Total Body Recumbent Stepper Training in Progressive MS: An Alternative Training Therapy for Patients With Impaired Mobility
What it found
We found no results in the registry or in papers.
This trial finished 15 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Total body recumbent stepper training
Compared with
- Body-weight supported treadmill training
What it measured
Main measures
Safety
baseline, 12 weeks (end of trial)
FatiguePainSafety
Other measures (6)
Expanded Disability Status Scale (EDSS) -neurologic function
baseline, 12 weeks (end)
Disability progressionMultiple Sclerosis Functional Composite (MSFC)-functional ability
baseline, 12 weeks (end)
Disability progressionThinking and memoryWalking and mobilityPhysical functionModified Fatigue Impact Scale (MFIS) -fatigue
baseline, 12 weeks (end)
Thinking and memoryFatigueMultiple Sclerosis Quality of Life-54 -quality of life questionnaire
baseline, 12 weeks (end)
Quality of life (reported by participants)Multiple Sclerosis Self-Efficacy Scale (MSSE) -ability to manage MS symptoms
baseline, 12 weeks (end)
Participant Satisfaction with Equipment
once -following 5 full exercise sessions
Physical functionPainQuality of life (reported by participants)
Who could take part
Relapsing and progressive · 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 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
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 recumbent stepper training or supported treadmill training
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Apr 2010
Main results due
Jun 2011
Finished
Aug 2011