Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737904
• Other study ID #: GN15PY148
• Secondary ID: PRF-15-BO1
• Status: Completed
• Phase: N/A
• First received: April 4, 2016
• Last updated: August 18, 2017
• Start date: August 1, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2017
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• Usual care
Personalised in-patient rehabilitation programme

Locations

Country	Name	City	State
United Kingdom	Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)	Score on Multiple Sclerosis Spasticity Scale (MSSS-88)	Change from Baseline at 4 weeks
Secondary	Spasticity scored on Modified Ashworth Scale (MAS)	Score on Modified Ashworth Scale (MAS)	Change from Baseline at 4 weeks
Secondary	Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)	Calculated Oxygen Uptake Efficiency Slope (OUES)	Change from Baseline at 4 weeks
Secondary	Function - FIM	Score on Functional Independence Measure (FIM)	Change from Baseline at 4 weeks
Secondary	Function - T25FW	Timed 25-foot walk test (T25FW)	Change from Baseline at 4 weeks
Secondary	Quality of Life (MSQOL)-54 scale	Score on Multiple Sclerosis Quality of Life (MSQOL)-54 scale	Change from Baseline at 4 weeks
Secondary	APT cycling performance - symmetry	Proportion of time when effort of right versus left leg is evenly distributed ie 50%/50%	Change from Baseline at 4 weeks
Secondary	APT cycling performance - distance	Distance cycled	Change from Baseline at 4 weeks
Secondary	APT cycling performance - power	Overall power (measured in watts)	Change from Baseline at 4 weeks