Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737904
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Tracking Information
First Submitted Date  ICMJE April 4, 2016
First Posted Date  ICMJE April 14, 2016
Last Update Posted Date August 22, 2017
Actual Study Start Date  ICMJE August 1, 2016
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88) [ Time Frame: Change from Baseline at 4 weeks ]
Score on Multiple Sclerosis Spasticity Scale (MSSS-88)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02737904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • Spasticity scored on Modified Ashworth Scale (MAS) [ Time Frame: Change from Baseline at 4 weeks ]
    Score on Modified Ashworth Scale (MAS)
  • Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES) [ Time Frame: Change from Baseline at 4 weeks ]
    Calculated Oxygen Uptake Efficiency Slope (OUES)
  • Function - FIM [ Time Frame: Change from Baseline at 4 weeks ]
    Score on Functional Independence Measure (FIM)
  • Function - T25FW [ Time Frame: Change from Baseline at 4 weeks ]
    Timed 25-foot walk test (T25FW)
  • Quality of Life (MSQOL)-54 scale [ Time Frame: Change from Baseline at 4 weeks ]
    Score on Multiple Sclerosis Quality of Life (MSQOL)-54 scale
  • APT cycling performance - symmetry [ Time Frame: Change from Baseline at 4 weeks ]
    Proportion of time when effort of right versus left leg is evenly distributed ie 50%/50%
  • APT cycling performance - distance [ Time Frame: Change from Baseline at 4 weeks ]
    Distance cycled
  • APT cycling performance - power [ Time Frame: Change from Baseline at 4 weeks ]
    Overall power (measured in watts)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Active-Passive Trainer Cycling on Multiple Sclerosis
Official Title  ICMJE The Effect of Cycling Using Active-passive Trainers on Spasticity, Cardiovascular Fitness, Function and Quality of Life in People With Multiple Sclerosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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.
  • Other: Usual care
    Personalised in-patient rehabilitation programme
Study Arms  ICMJE
  • Active Comparator: Control group
    Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration
    Intervention: Other: Usual care
  • Experimental: Intervention group
    Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration
    Interventions:
    • Other: APT
    • Other: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2017)
24
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2016)
30
Actual Study Completion Date  ICMJE July 31, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02737904
Other Study ID Numbers  ICMJE GN15PY148
PRF-15-BO1 ( Other Grant/Funding Number: Chartered Society of Physiotherapy Charitable Trust Award )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NHS Greater Glasgow and Clyde
Study Sponsor  ICMJE NHS Greater Glasgow and Clyde
Collaborators  ICMJE University of Glasgow
Investigators  ICMJE
Principal Investigator: Lorna Paul, BSc MPhil PhD University of Glasgow
PRS Account NHS Greater Glasgow and Clyde
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP