Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

NHS Trust

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Usual care; Other: APT

Study type: Interventional

Funder types: Other

Identifiers

NCT02737904

GN15PY148

PRF-15-BO1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Control group

Active Comparator group

Description:

Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration

Treatment:

Other: Usual care

Intervention group

Experimental group

Description:

Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration

Treatment:

Other: APT

Other: Usual care