Multiple SclerosisNCT02737904
Effect of Active-Passive Trainer Cycling on Multiple Sclerosis
A study testing APT in people with Multiple Sclerosis, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- APT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2016to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital
Glasgow, G51 4TF
About this study
Official title: 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.
Read the 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
- Being tested
- APT, Usual care
- Keywords
- Muscle spasticity
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APTOther
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 careOther
Personalised in-patient rehabilitation programme
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration Receives: Other: Usual care |
| Intervention group | Experimental | Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration Receives: Other: APT; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)
Score on Multiple Sclerosis Spasticity Scale (MSSS-88)
Measured: Change from Baseline at 4 weeks
Secondary outcomes (8)
Spasticity scored on Modified Ashworth Scale (MAS)
Score on Modified Ashworth Scale (MAS)
Measured: Change from Baseline at 4 weeks
Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)
Calculated Oxygen Uptake Efficiency Slope (OUES)
Measured: Change from Baseline at 4 weeks
Function - FIM
Score on Functional Independence Measure (FIM)
Measured: Change from Baseline at 4 weeks
Function - T25FW
Timed 25-foot walk test (T25FW)
Measured: Change from Baseline at 4 weeks
Quality of Life (MSQOL)-54 scale
Score on Multiple Sclerosis Quality of Life (MSQOL)-54 scale
Measured: 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%
Measured: Change from Baseline at 4 weeks
APT cycling performance - distance
Distance cycled
Measured: Change from Baseline at 4 weeks
APT cycling performance - power
Overall power (measured in watts)
Measured: Change from Baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Lorna Paul, BSc MPhil PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737904
- Sponsor's protocol ID
- GN15PY148
- Other IDs
- PRF-15-BO1
- Status last verified
- Aug 2017
- First submitted
- 4 Apr 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cycling Using Active-passive Trainers on Spasticity, Cardiovascular Fitness, Function and Quality of Life in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02737904
- Acronym / sponsor ID
- GN15PY148
- Conditions
- Multiple Sclerosis
- Keywords
- Muscle spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Usual careUsual care - conventional, personalised in-patient rehabilitation 4 weeks duration |
| Intervention group | Experimental | Other: APT, Other: Usual careUsual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APTAPT 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 | Intervention group |
| Usual carePersonalised in-patient rehabilitation programme | Other | Control group, Intervention group |
Primary outcome
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)
8 secondary outcomes
Spasticity scored on Modified Ashworth Scale (MAS)
Time frame: Change from Baseline at 4 weeks
Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)
Time frame: Change from Baseline at 4 weeks
Function - FIM
Time frame: Change from Baseline at 4 weeks
Function - T25FW
Time frame: Change from Baseline at 4 weeks
Quality of Life (MSQOL)-54 scale
Time frame: Change from Baseline at 4 weeks
APT cycling performance - symmetry
Time frame: Change from Baseline at 4 weeks
APT cycling performance - distance
Time frame: Change from Baseline at 4 weeks
APT cycling performance - power
Time frame: Change from Baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna Paul, BSc MPhil PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APT in people with Multiple Sclerosis, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88) (time frame: Change from Baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.