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Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
APT
Usual care
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Muscle spasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)
Score on Multiple Sclerosis Spasticity Scale (MSSS-88)

Secondary Outcome Measures

Spasticity scored on Modified Ashworth Scale (MAS)
Score on Modified Ashworth Scale (MAS)
Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)
Calculated Oxygen Uptake Efficiency Slope (OUES)
Function - FIM
Score on Functional Independence Measure (FIM)
Function - T25FW
Timed 25-foot walk test (T25FW)
Quality of Life (MSQOL)-54 scale
Score on Multiple Sclerosis Quality of Life (MSQOL)-54 scale
APT cycling performance - symmetry
Proportion of time when effort of right versus left leg is evenly distributed ie 50%/50%
APT cycling performance - distance
Distance cycled
APT cycling performance - power
Overall power (measured in watts)

Full Information

First Posted
April 4, 2016
Last Updated
August 18, 2017
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT02737904
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Muscle spasticity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration
Intervention Type
Other
Intervention Name(s)
APT
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Personalised in-patient rehabilitation programme
Primary Outcome Measure Information:
Title
Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)
Description
Score on Multiple Sclerosis Spasticity Scale (MSSS-88)
Time Frame
Change from Baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Spasticity scored on Modified Ashworth Scale (MAS)
Description
Score on Modified Ashworth Scale (MAS)
Time Frame
Change from Baseline at 4 weeks
Title
Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)
Description
Calculated Oxygen Uptake Efficiency Slope (OUES)
Time Frame
Change from Baseline at 4 weeks
Title
Function - FIM
Description
Score on Functional Independence Measure (FIM)
Time Frame
Change from Baseline at 4 weeks
Title
Function - T25FW
Description
Timed 25-foot walk test (T25FW)
Time Frame
Change from Baseline at 4 weeks
Title
Quality of Life (MSQOL)-54 scale
Description
Score on Multiple Sclerosis Quality of Life (MSQOL)-54 scale
Time Frame
Change from Baseline at 4 weeks
Title
APT cycling performance - symmetry
Description
Proportion of time when effort of right versus left leg is evenly distributed ie 50%/50%
Time Frame
Change from Baseline at 4 weeks
Title
APT cycling performance - distance
Description
Distance cycled
Time Frame
Change from Baseline at 4 weeks
Title
APT cycling performance - power
Description
Overall power (measured in watts)
Time Frame
Change from Baseline at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna Paul, BSc MPhil PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

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