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Completed

NCT Number: NCT02737904

Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

APT

Other

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.

Usual Care

Other

Personalised in-patient rehabilitation programme

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

The Effect of Cycling Using Active-passive Trainers on Spasticity, Cardiovascular Fitness, Function and Quality of Life in People With Multiple Sclerosis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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