Clinical trial NCT02737904: Effect of Active-Passive Trainer Cycling on Multiple Sclerosis
Official title: The Effect of Cycling Using Active-passive Trainers on Spasticity, Cardiovascular Fitness, Function and Quality of Life in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Muscle spasticity
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2016-04-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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)

Primary outcomes:
measure: Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)
timeFrame: Change from Baseline at 4 weeks
Secondary outcomes:
measure: Spasticity scored on Modified Ashworth Scale (MAS)
timeFrame: Change from Baseline at 4 weeks
measure: Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)
timeFrame: Change from Baseline at 4 weeks
measure: Function - FIM
timeFrame: Change from Baseline at 4 weeks
measure: Function - T25FW
timeFrame: Change from Baseline at 4 weeks
measure: Quality of Life (MSQOL)-54 scale
timeFrame: Change from Baseline at 4 weeks
measure: APT cycling performance - symmetry
timeFrame: Change from Baseline at 4 weeks
measure: APT cycling performance - distance
timeFrame: Change from Baseline at 4 weeks
measure: APT cycling performance - power
timeFrame: Change from Baseline at 4 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital
Study officials:
affiliation: University of Glasgow
name: Lorna Paul, BSc MPhil PhD
role: PRINCIPAL_INVESTIGATOR
References: