NCT02737904

Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2016-04-14
• Last updated: 2017-08-22

Locations

1 site across 1 country: United Kingdom