Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

NCT ID: NCT02737904

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2017-07-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Personalised in-patient rehabilitation programme

Intervention group

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

Group Type: EXPERIMENTAL

APT

Intervention Type: OTHER

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

Intervention Type: OTHER

Personalised in-patient rehabilitation programme

Interventions

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.

Intervention Type: OTHER

Usual care

Personalised in-patient rehabilitation programme

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorna Paul, BSc MPhil PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

PRF-15-BO1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GN15PY148

Identifier Type: -

Identifier Source: org_study_id