Multiple SclerosisNCT01097538
Study of Alternative Exercise Therapies for Progressive Multiple Sclerosis (MS)
A study testing Body-weight supported treadmill training and Total body recumbent stepper training in people with Multiple Sclerosis, run by Hicks, Audrey, Ph.D. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Body-weight supported treadmill training and Total body recumbent stepper training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Health Promotion and Rehabilitation, McMaster University
Hamilton, Ontario, L8S 4K1
About this study
Official title: Total Body Recumbent Stepper Training in Progressive MS: An Alternative Training Therapy for Patients With Impaired Mobility
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.
Read the detailed description
We are proposing to evaluate the clinical utility and efficacy of a new therapeutic exercise modality for patients with progressive MS with severe functional impairments.
Progressive MS patients have limited treatment options and reach higher disability levels at a faster rate than relapsing remitting MS patients. Consequently, finding solutions to maintain function and improve quality of life of patients with progressive MS is essential.
A traditional training modality for patients with limited mobility is body-weight supported treadmill training (BWSTT). Our preliminary results support the efficacy of BWSTT in progressive MS patients; however, the financial burden and labour-intensive nature of BWSTT does not make it a viable option for most settings. For the aforementioned reasons, we are proposing total body recumbent stepper training (TBRST) as an alternative therapy for progressive MS patients with mobility impairments. TBRST is advantageous over BWSTT in that it has low set-up and maintenance costs, is easily used by patients with limited mobility and requires minimal assistance to operate. TBRST has the potential to become part of conventional MS treatment programs and could easily be incorporated into home and community settings. The primary aim of this investigation is to establish safety and satisfaction with TBRST in progressive MS patients. Second, we plan to determine if TBRST is as effective as a BWSTT as a therapeutic modality.
Twenty patients with progressive MS (primary and secondary) of high disability level (EDSS 6.0-8.0) will be recruited to participate in this study. Both primary and secondary MS patients will be included due to similarities in disease progression and a lack of available alternative treatments for this population. Patients will be randomized to either the TBRST or BWSTT intervention; there will be 10 patients in each group. Patients in the TBRST program will train using the Nustep (TRS 4000) recumbent cross trainer. The recumbent cross trainer allows patients to move their legs in a natural stepping motion with bilateral reciprocal movement of the arms from a seated position. Foot straps, leg stabilizers and hand stabilizers may be used for added control and proper body alignment when necessary. Patients in the BWSTT group will exercise using the Woodway Loco-system which allows a portion of the patient's body-weight to be off-loaded by an overhead pulley system. Treadmill therapists will guide the patients' legs through a proper gait motion and assist with lower limb control.
Participants in both interventions will complete three weekly exercise sessions of 30min, for the duration of 12 weeks. Perceived exertion will be used as an indicator of exercise intensity and will guide program progression. Both intervention groups will maintain a perceived exertion of 5-7 on the Borg CR10 Scale throughout the exercise program. All patients will be evaluated at baseline and following 12 weeks on a variety of outcome measures. Primary outcome measures will be safety and satisfaction with TBRST. Secondary outcomes will be functional ability using the EDSS and MSFC, quality of life using the MSQOL-54, fatigue using the MFIS and MS self-efficacy using the MSSE. The proposed research will take place over one year with enrolment and intervention programs commencing in a graded manner.
- Conditions
- Multiple Sclerosis
- Being tested
- Body-weight supported treadmill training, Total body recumbent stepper training
- Keywords
- exercise, rehabilitation, progressive multiple sclerosis, functional ability, fatigue, quality of life
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Multiple Sclerosis, Chronic Progressive, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-weight supported treadmill trainingOther
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.
Total body recumbent stepper trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Body-weight supported treadmill training | Active comparator | Supported treadmill walking Receives: Other: Body-weight supported treadmill training |
| Total body recumbent stepper training | Experimental | Recumbent stepper exercise training Receives: Other: Total body recumbent stepper training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 12 weeks (end of trial)
Secondary outcomes (6)
Expanded Disability Status Scale (EDSS) -neurologic function
The EDSS provides a measure of physical function specifically in MS patients and is scored from 0-10. This will be assessed by a train neurologist.
Measured: baseline, 12 weeks (end)
Multiple Sclerosis Functional Composite (MSFC)-functional ability
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.
Measured: baseline, 12 weeks (end)
Modified Fatigue Impact Scale (MFIS) -fatigue
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.
Measured: baseline, 12 weeks (end)
Multiple Sclerosis Quality of Life-54 -quality of life questionnaire
The MSQOL-54 is an MS-specific measure of QOL that consists of 54 items divided into 12 multi-item scales, 2 single-item scales, and 2 composite scores (physical and mental health).
Measured: baseline, 12 weeks (end)
Multiple Sclerosis Self-Efficacy Scale (MSSE) -ability to manage MS symptoms
The MSSE is an 18-item questionnaire which evaluates self-efficacy on two multi-item subscales: function and control. Each subscale ranges from 10 (very uncertain) to 100 (very certain) on how certain the individual is in their function or control of their MS symptoms.
Measured: baseline, 12 weeks (end)
Participant Satisfaction with Equipment
In order to assess satisfaction with equipment, patients will be asked a series of questions concerning the accessibility, perceived benefit, enjoyment and after-effects of using both equipment modalities. This questionnaire is composed of a series of scales compiled from a number of sources including the Brief Pain Inventory, the Feeling Scale and the Exercise Feeling Inventory.
Measured: once -following 5 full exercise sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hicks, Audrey, Ph.D.
- Investigators
- Audrey Hicks, PhD, Principal investigator, McMaster UniversityLara Pilutti, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097538
- Sponsor's protocol ID
- Hicks -MS exercise
- Status last verified
- Aug 2011
- First submitted
- 31 Mar 2010
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Body Recumbent Stepper Training in Progressive MS: An Alternative Training Therapy for Patients With Impaired Mobility
- ClinicalTrials.gov ID
- NCT01097538
- Acronym / sponsor ID
- Hicks -MS exercise
- Conditions
- Multiple Sclerosis
- Keywords
- exercise, rehabilitation, progressive multiple sclerosis, functional ability, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hicks, Audrey, Ph.D.
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We are proposing to evaluate the clinical utility and efficacy of a new therapeutic exercise modality for patients with progressive MS with severe functional impairments.
Progressive MS patients have limited treatment options and reach higher disability levels at a faster rate than relapsing remitting MS patients. Consequently, finding solutions to maintain function and improve quality of life of patients with progressive MS is essential.
A traditional training modality for patients with limited mobility is body-weight supported treadmill training (BWSTT). Our preliminary results support the efficacy of BWSTT in progressive MS patients; however, the financial burden and labour-intensive nature of BWSTT does not make it a viable option for most settings. For the aforementioned reasons, we are proposing total body recumbent stepper training (TBRST) as an alternative therapy for progressive MS patients with mobility impairments. TBRST is advantageous over BWSTT in that it has low set-up and maintenance costs, is easily used by patients with limited mobility and requires minimal assistance to operate. TBRST has the potential to become part of conventional MS treatment programs and could easily be incorporated into home and community settings. The primary aim of this investigation is to establish safety and satisfaction with TBRST in progressive MS patients. Second, we plan to determine if TBRST is as effective as a BWSTT as a therapeutic modality.
Twenty patients with progressive MS (primary and secondary) of high disability level (EDSS 6.0-8.0) will be recruited to participate in this study. Both primary and secondary MS patients will be included due to similarities in disease progression and a lack of available alternative treatments for this population. Patients will be randomized to either the TBRST or BWSTT intervention; there will be 10 patients in each group. Patients in the TBRST program will train using the Nustep (TRS 4000) recumbent cross trainer. The recumbent cross trainer allows patients to move their legs in a natural stepping motion with bilateral reciprocal movement of the arms from a seated position. Foot straps, leg stabilizers and hand stabilizers may be used for added control and proper body alignment when necessary. Patients in the BWSTT group will exercise using the Woodway Loco-system which allows a portion of the patient's body-weight to be off-loaded by an overhead pulley system. Treadmill therapists will guide the patients' legs through a proper gait motion and assist with lower limb control.
Participants in both interventions will complete three weekly exercise sessions of 30min, for the duration of 12 weeks. Perceived exertion will be used as an indicator of exercise intensity and will guide program progression. Both intervention groups will maintain a perceived exertion of 5-7 on the Borg CR10 Scale throughout the exercise program. All patients will be evaluated at baseline and following 12 weeks on a variety of outcome measures. Primary outcome measures will be safety and satisfaction with TBRST. Secondary outcomes will be functional ability using the EDSS and MSFC, quality of life using the MSQOL-54, fatigue using the MFIS and MS self-efficacy using the MSSE. The proposed research will take place over one year with enrolment and intervention programs commencing in a graded manner.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body-weight supported treadmill training | Active comparator | Other: Body-weight supported treadmill trainingSupported treadmill walking |
| Total body recumbent stepper training | Experimental | Other: Total body recumbent stepper trainingRecumbent stepper exercise training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body-weight supported treadmill trainingPatients 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. | Other | Body-weight supported treadmill training |
| Total body recumbent stepper trainingPatients 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. | Other | Total body recumbent stepper training |
Primary outcome
Safety
Time frame: baseline, 12 weeks (end of trial)
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.
6 secondary outcomes
Expanded Disability Status Scale (EDSS) -neurologic function
Time frame: baseline, 12 weeks (end)
Multiple Sclerosis Functional Composite (MSFC)-functional ability
Time frame: baseline, 12 weeks (end)
Modified Fatigue Impact Scale (MFIS) -fatigue
Time frame: baseline, 12 weeks (end)
Multiple Sclerosis Quality of Life-54 -quality of life questionnaire
Time frame: baseline, 12 weeks (end)
Multiple Sclerosis Self-Efficacy Scale (MSSE) -ability to manage MS symptoms
Time frame: baseline, 12 weeks (end)
Participant Satisfaction with Equipment
Time frame: once -following 5 full exercise sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Hicks, PhD principal investigator
McMaster University
Lara Pilutti principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body-weight supported treadmill training and Total body recumbent stepper training in people with Multiple Sclerosis, run by Hicks, Audrey, Ph.D. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: baseline, 12 weeks (end of trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2011.