Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Usual care; Other: APT

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration	Other: Usual care; Personalised in-patient rehabilitation programme
Experimental: Intervention group; Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration	Other: Usual care; Personalised in-patient rehabilitation programme; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity scored on Modified Ashworth Scale (MAS)	Score on Modified Ashworth Scale (MAS)	Change from Baseline at 4 weeks
Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)	Calculated Oxygen Uptake Efficiency Slope (OUES)	Change from Baseline at 4 weeks
Function - FIM	Score on Functional Independence Measure (FIM)	Change from Baseline at 4 weeks
Function - T25FW	Timed 25-foot walk test (T25FW)	Change from Baseline at 4 weeks
Quality of Life (MSQOL)-54 scale	Score on Multiple Sclerosis Quality of Life (MSQOL)-54 scale	Change from Baseline at 4 weeks
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
APT cycling performance - distance	Distance cycled	Change from Baseline at 4 weeks
APT cycling performance - power	Overall power (measured in watts)	Change from Baseline at 4 weeks

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Lorna Paul, BSc MPhil PhD, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Muscle spasticity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: GN15PY148; PRF-15-BO1 (Other Grant/Funding Number: Chartered Society of Physiotherapy Charitable Trust Award)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No