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Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02737904
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:
This randomised controlled trial aims to explore the effectiveness of a four week programme of exercise using lower limb Active Passive trainer (APT) (MOTOmed trainer) in terms of spasticity in people with moderate to severe Multiple Sclerosis.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: APT Other: Usual care Not Applicable

Detailed Description:

Exercise is beneficial for people with Multiple Sclerosis (pwMS). However, exercise options for those with moderate to high levels of disability are limited. Cycling, delivered with an Active Passive Trainer (APT) is one exercise option often offered within rehabilitation/exercise settings and many pwMS buy APTs for home use. Anecdotally, pwMS report they feel better and their spasticity reduces after APT cycling, however there is a lack of evidence to support this.

30 pwMS will be recruited from the Physical Disability Rehabilitation Unit at the Queen Elizabeth University Hospital, Glasgow, and randomised to APT + usual care or usual care only. Those in the APT group will receive 30 minutes of APT (2 mins passive warm up, 26 mins active cycling and 2 mins passive cool down), five days per week for 4 weeks. Outcome measures will be cardiovascular fitness measured using the oxygen uptake efficiency slope (OUES), spasticity assessed by Modified Ashworth Scale (MAS) and the Multiple Sclerosis Spasticity Scale (MSSS-88), function assessed by the Functional Independence Measure (FIM) and the Timed 25 foot walk test (T25FW), Quality of Life measured by MSQOL-54. Outcome measures will be assessed in both groups before and after the 4 week intervention period. Symmetry, distance cycled and power will be recorded following each cycling session in the intervention group.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Cycling Using Active-passive Trainers on Spasticity, Cardiovascular Fitness, Function and Quality of Life in People With Multiple Sclerosis
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration
Other: Usual care
Personalised in-patient rehabilitation programme

Experimental: Intervention group
Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration
Other: APT
APT for 30 minutes per day on 5 days per week for 4 weeks: 2 minute warm up consisting of passive cycling, where the legs of the participant are moved passively by the APT at 10 revolutions per min (rpm). Next, the participant will cycle for up to 26 minutes, at 60rpm. In this phase, the participant is required to actively cycle and to maintain a symmetrical pattern of movement using the feedback on the display. If the participant is unable to actively cycle at any point during the 26 minute exercise period, or if they have a spasm, the MOTOmed APT will revert to the passive mode. The final phase is a cool down where participants again will have 2 minutes of passive cycling at 10rpm.

Other: Usual care
Personalised in-patient rehabilitation programme




Primary Outcome Measures :
  1. Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88) [ Time Frame: Change from Baseline at 4 weeks ]
    Score on Multiple Sclerosis Spasticity Scale (MSSS-88)


Secondary Outcome Measures :
  1. Spasticity scored on Modified Ashworth Scale (MAS) [ Time Frame: Change from Baseline at 4 weeks ]
    Score on Modified Ashworth Scale (MAS)

  2. Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES) [ Time Frame: Change from Baseline at 4 weeks ]
    Calculated Oxygen Uptake Efficiency Slope (OUES)

  3. Function - FIM [ Time Frame: Change from Baseline at 4 weeks ]
    Score on Functional Independence Measure (FIM)

  4. Function - T25FW [ Time Frame: Change from Baseline at 4 weeks ]
    Timed 25-foot walk test (T25FW)

  5. Quality of Life (MSQOL)-54 scale [ Time Frame: Change from Baseline at 4 weeks ]
    Score on Multiple Sclerosis Quality of Life (MSQOL)-54 scale

  6. APT cycling performance - symmetry [ Time Frame: Change from Baseline at 4 weeks ]
    Proportion of time when effort of right versus left leg is evenly distributed ie 50%/50%

  7. APT cycling performance - distance [ Time Frame: Change from Baseline at 4 weeks ]
    Distance cycled

  8. APT cycling performance - power [ Time Frame: Change from Baseline at 4 weeks ]
    Overall power (measured in watts)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have a confirmed diagnosis of progressive MS
  • are aged over 18 years
  • have an Expanded Disability Status Scale (EDSS) of between 6.5 (requires two walking aids - pair of canes, crutches, etc - to walk about 20m without resting) and 8.5 (essentially restricted to bed much of day); has some effective use of arms (retains some self care functions) and spasticity in their lower limbs (self reported)

Exclusion Criteria:

  • cognitive impairment (cannot understand instructions)
  • other co-morbidities which would preclude them taking part in exercise
  • visual impairment (such that they cannot see the screen on the APT)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737904


Locations
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United Kingdom
Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Lorna Paul, BSc MPhil PhD University of Glasgow

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02737904     History of Changes
Other Study ID Numbers: GN15PY148
PRF-15-BO1 ( Other Grant/Funding Number: Chartered Society of Physiotherapy Charitable Trust Award )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NHS Greater Glasgow and Clyde:
Muscle spasticity

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases