Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Usual care; Other: APT

• Registration Number: NCT02737904
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-14
• Study Start: 2016-08-01
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Usual care	Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration
Intervention group	Usual care	Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration
Intervention group	APT	Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration

Primary Outcome Measures

Name	Time	Method
Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)	Change from Baseline at 4 weeks	Score on Multiple Sclerosis Spasticity Scale (MSSS-88)

Secondary Outcome Measures

Name	Time	Method
Spasticity scored on Modified Ashworth Scale (MAS)	Change from Baseline at 4 weeks	Score on Modified Ashworth Scale (MAS)
Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)	Change from Baseline at 4 weeks	Calculated Oxygen Uptake Efficiency Slope (OUES)
Function - FIM	Change from Baseline at 4 weeks	Score on Functional Independence Measure (FIM)
Function - T25FW	Change from Baseline at 4 weeks	Timed 25-foot walk test (T25FW)
Quality of Life (MSQOL)-54 scale	Change from Baseline at 4 weeks	Score on Multiple Sclerosis Quality of Life (MSQOL)-54 scale
APT cycling performance - symmetry	Change from Baseline at 4 weeks	Proportion of time when effort of right versus left leg is evenly distributed ie 50%/50%
APT cycling performance - distance	Change from Baseline at 4 weeks	Distance cycled
APT cycling performance - power	Change from Baseline at 4 weeks	Overall power (measured in watts)

Trial Locations

Locations (1)

Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom