Multiple SclerosisNCT02421744
A Task-oriented Circuit Training in Multiple Sclerosis
A study testing Task Oriented Circuit Training and Delayed Onset TOCT in people with Multiple Sclerosis, run by University Hospital of Ferrara at 2 sites in Italy.
Trial summary
Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training followed by a structured 3 months home exercise program would have higher benefits compared to a delayed-treatment group as control in people with multiple sclerosis and mild to moderate gait impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Task Oriented Circuit Training and Delayed Onset TOCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2015to Oct 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females,
- community dwelling,
- age >18 and <75
- diagnosis of multiple sclerosis in a stable phase, with relapses > 3 months prior to study enrollment
- moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5
- MMSE >24
Who cannot join
- neurologic conditions in addition to multiple sclerosis that may affect motor function
- medical conditions likely to interfere with the ability to safely complete the study
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ferrara University Hospital
Ferrara
Azienda Ospedaliera Universitaria Pisana
Pisa
About this study
Official title: A Task-oriented Circuit Training in Multiple Sclerosis: a Multicentric Randomized Controlled Trial
Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training followed by a structured 3 months home exercise program would have higher benefits compared to a delayed-treatment group as control in people with multiple sclerosis and mild to moderate gait impairment.
Our secondary hypothesis is that there could be retention of clinical gains in subjects that underwent TOCT plus structured 3 months home exercise program.
Read the detailed description
This is a single blind randomized-controlled trial to test the effects of a task oriented training on locomotor function, mobility and balance in multiple sclerosis subjects with mild to moderate gait impairments (EDSS 4-5.5).
Subjects and methods:54 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics (Azienda Ospedaliero- Universitaria di Ferrara and Azienda Ospedaliero-Universitaria Pisana). Informed consent will be obtained. Participants enrolled will be included in 2 different treatment groups: experimental group will receive 10 TOCT sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program, whereas control group will be included into a delayed-treatment group. Three subjects with a supervisor physiotherapist will take part at the TOCT. Primary outcome measure will be walking endurance (Six Minute Walking Test); as secondary outcome we will test gait speed (Timed 25-Foot Walk), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); through self-assessment questionnaires we will evaluate motor fatigue (Modified Fatigue Impact Scale - MFIS), walking ability (Multiple Sclerosis Walking Scale - 12), health-related quality of life (Multiple Sclerosis Impact Scale - 29 and Functional Assessment of Multiple Sclerosis). In addition to clinical outcomes, in a convenience sample we will have: (i) balance assessment (force platform); (ii) motorcortex oxygenation during walking (fNIRS); (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) mechanical and electrical fatigue assessment; (vi) brain connectivity (EEG). Outcome measures will be assessed 1 week prior to treatment initiation (T0), after two weeks to treatment initiation (T1), after the 3 months exercise program (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to the treatment.
The specific aims will be (i) to test the effects on walking, mobility, balance, fatigue and health-related quality of life; (ii) to test the effects on cerebral oxygenation (fNIRS) during walking; (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) Mechanical and electrical fatigue assessment; (vi) brain connectivity (EEG) and (vii) to investigate the 3 months home exercise program's feasibility, satisfaction and adherence.
- Conditions
- Multiple Sclerosis
- Being tested
- Task Oriented Circuit Training, Delayed Onset TOCT
- Keywords
- rehabilitation, Multiple Sclerosis, mobility, gait, task-oriented training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task Oriented Circuit TrainingBehavioural
TOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months.
Delayed Onset TOCTBehavioural
The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Task Oriented Circuit Training | Experimental | TOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months. Receives: Behavioral: Task Oriented Circuit Training |
| Delayed Onset TOCT | Active comparator | The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months. Receives: Behavioral: Delayed Onset TOCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walking Test
The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes, with the possibility to slow down and rest if necessary.
Measured: Weeks: 0,2,14, 26
Secondary outcomes (13)
Timed 25-Foot walk (25FWT)
a quantitative measure of lower extremity function, also included in the Multiple Sclerosis Functional Composite (MSFC) . The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet (7.62m) as quickly as possible, but safely, using the prescribed assistive devices. The task is immediately administered again by having the patient walk back the same distance. Test will be performed according to the instructions reported on the manual of the National Multiple Sclerosis Society .
Measured: weeks: 0,2,14, 26
Time Up and Go Test
Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch.
Measured: weeks: 0,2,14, 26
Dynamic Gait Index (DGI)
Assesses individual's ability to modify balance while walking in the presence of external demands
Measured: weeks: 0,2,14, 26
Modified fatigue impact scale (MFIS)
The MFIS is a modified form of the Fatigue Impact Scale (Fisk et al, 1994) based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning.
Measured: weeks: 0,2,14, 26
Multiple Sclerosis Walking Scale - 12 (MSWS-12)
The 12-item multiple sclerosis walking scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability.
Measured: weeks: 0,2,14, 26
Multiple Sclerosis Impact Scale- 29 (MSIS-29)
This is an health-rated quality of life questionnaire that assesses the impact of MS on physical and psychological functions. It is formed by 29 items on ADL I and II: 20 about physical activity and 9 of psychological status of the person. Each item can be scored with a value from 0 to 5; total score is given by the sum of all the items and then is transformed in a range from 0 to 100. A higher value correspond to a worse perception of subject's HRQoL.
Measured: weeks: 0,2,14, 26
Functional Assessment of Multiple Sclerosis (FAMS)
Quality of life instrument of for use in people with MS. Consists of 59 items (44 of which are scored) in six quality of life domains. Higher scores indicate better quality of life.
Measured: weeks: 0,2,14, 26
Metabolic cerebral measurements by Near infrared spectroscopy
Near InfraRed Spectroscopy (NIRS) is a noninvasive, portable technique for ambulatory or remote monitoring of human motor-cortex oxygenation changes in response to motor tasks. Patients will walk on the treadmill at a speed of 0.2 km/h assisted by personnel and with partial body weight support, performing 4 short tasks (30 seconds of walking) alternated by rest periods (30 seconds).
Measured: weeks: 0,2,14, 26
Postural sway (Center of pressure (COP) trajectories)
Center of pressure (COP) trajectories
Measured: weeks: 0,2,14, 26
Force and EMG signal (perform an isometric extension of the knees on an isokinetic dynamometer (PrimusRS BTETM Technology), achieving their own Maximum Voluntary Contraction (MVC)
Patients will perform an isometric extension of the knees on an isokinetic dynamometer (PrimusRS BTETM Technology), achieving their own Maximum Voluntary Contraction (MVC) during a set of 3 seconds trials.
Measured: weeks: 0,2,14, 26
Mechanical and electrical fatigue assessment (evaluated measuring sustained contractions in isometric tasks in lower limbs on an isokinetic dynamometer (PrimusRS BTETM Technology)
Muscle fatigue will be evaluated measuring sustained contractions in isometric tasks in lower limbs on an isokinetic dynamometer (PrimusRS BTETM Technology), maintaining a MVC for knee and ankle extension for 60 s.
Measured: weeks: 0,2,14, 26
Brain plasticity and connectivity (High density EEG and vertical electrooculogram (EOG) will be recorded with a standard bipolar 64-channels montage and a DC-coupled amplifier (Micromed SD MRI, System Plus acquisition software)
High density EEG and vertical electrooculogram (EOG) will be recorded with a standard bipolar 64-channels montage and a DC-coupled amplifier (Micromed SD MRI, System Plus acquisition software).
Measured: weeks: 0,2,14, 26
Metabolic muscular measurements by Near infrared spectroscopy
Noninvasive muscle measurements will be performed at gastrocnemius by an optical imaging system consisting of 2 light source fibers and 2 detector fibers.
Measured: weeks: 0,2,14, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2018
- Study completionOct 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Straudi, MD, Principal investigator, Ferrara Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421744
- Sponsor's protocol ID
- Studio multicentrico TOCT SM
- Status last verified
- May 2017
- First submitted
- 19 Jan 2015
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Task-oriented Circuit Training in Multiple Sclerosis: a Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02421744
- Acronym / sponsor ID
- Studio multicentrico TOCT SM
- Conditions
- Multiple Sclerosis
- Keywords
- rehabilitation, Multiple Sclerosis, mobility, gait, task-oriented training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 21 Apr 2015 (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.
Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training followed by a structured 3 months home exercise program would have higher benefits compared to a delayed-treatment group as control in people with multiple sclerosis and mild to moderate gait impairment.
Our secondary hypothesis is that there could be retention of clinical gains in subjects that underwent TOCT plus structured 3 months home exercise program.
Detailed description
This is a single blind randomized-controlled trial to test the effects of a task oriented training on locomotor function, mobility and balance in multiple sclerosis subjects with mild to moderate gait impairments (EDSS 4-5.5).
Subjects and methods:54 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics (Azienda Ospedaliero- Universitaria di Ferrara and Azienda Ospedaliero-Universitaria Pisana). Informed consent will be obtained. Participants enrolled will be included in 2 different treatment groups: experimental group will receive 10 TOCT sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program, whereas control group will be included into a delayed-treatment group. Three subjects with a supervisor physiotherapist will take part at the TOCT. Primary outcome measure will be walking endurance (Six Minute Walking Test); as secondary outcome we will test gait speed (Timed 25-Foot Walk), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); through self-assessment questionnaires we will evaluate motor fatigue (Modified Fatigue Impact Scale - MFIS), walking ability (Multiple Sclerosis Walking Scale - 12), health-related quality of life (Multiple Sclerosis Impact Scale - 29 and Functional Assessment of Multiple Sclerosis). In addition to clinical outcomes, in a convenience sample we will have: (i) balance assessment (force platform); (ii) motorcortex oxygenation during walking (fNIRS); (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) mechanical and electrical fatigue assessment; (vi) brain connectivity (EEG). Outcome measures will be assessed 1 week prior to treatment initiation (T0), after two weeks to treatment initiation (T1), after the 3 months exercise program (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to the treatment.
The specific aims will be (i) to test the effects on walking, mobility, balance, fatigue and health-related quality of life; (ii) to test the effects on cerebral oxygenation (fNIRS) during walking; (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) Mechanical and electrical fatigue assessment; (vi) brain connectivity (EEG) and (vii) to investigate the 3 months home exercise program's feasibility, satisfaction and adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task Oriented Circuit Training | Experimental | Behavioral: Task Oriented Circuit TrainingTOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months. |
| Delayed Onset TOCT | Active comparator | Behavioral: Delayed Onset TOCTThe control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males and females,
- community dwelling,
- age >18 and <75
- diagnosis of multiple sclerosis in a stable phase, with relapses > 3 months prior to study enrollment
- moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5
Key exclusion criteria (3 listed)
- neurologic conditions in addition to multiple sclerosis that may affect motor function
- medical conditions likely to interfere with the ability to safely complete the study
- pregnancy
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 |
|---|---|---|
| Task Oriented Circuit TrainingTOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months. | Behavioural | Task Oriented Circuit Training |
| Delayed Onset TOCTThe control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months. | Behavioural | Delayed Onset TOCT |
Primary outcome
Six-Minute Walking Test
Time frame: Weeks: 0,2,14, 26
The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes, with the possibility to slow down and rest if necessary.
13 secondary outcomes
Timed 25-Foot walk (25FWT)
Time frame: weeks: 0,2,14, 26
Time Up and Go Test
Time frame: weeks: 0,2,14, 26
Dynamic Gait Index (DGI)
Time frame: weeks: 0,2,14, 26
Modified fatigue impact scale (MFIS)
Time frame: weeks: 0,2,14, 26
Multiple Sclerosis Walking Scale - 12 (MSWS-12)
Time frame: weeks: 0,2,14, 26
Multiple Sclerosis Impact Scale- 29 (MSIS-29)
Time frame: weeks: 0,2,14, 26
Functional Assessment of Multiple Sclerosis (FAMS)
Time frame: weeks: 0,2,14, 26
Metabolic cerebral measurements by Near infrared spectroscopy
Time frame: weeks: 0,2,14, 26
Postural sway (Center of pressure (COP) trajectories)
Time frame: weeks: 0,2,14, 26
Force and EMG signal (perform an isometric extension of the knees on an isokinetic dynamometer (PrimusRS BTETM Technology), achieving their own Maximum Voluntary Contraction (MVC)
Time frame: weeks: 0,2,14, 26
Mechanical and electrical fatigue assessment (evaluated measuring sustained contractions in isometric tasks in lower limbs on an isokinetic dynamometer (PrimusRS BTETM Technology)
Time frame: weeks: 0,2,14, 26
Brain plasticity and connectivity (High density EEG and vertical electrooculogram (EOG) will be recorded with a standard bipolar 64-channels montage and a DC-coupled amplifier (Micromed SD MRI, System Plus acquisition software)
Time frame: weeks: 0,2,14, 26
Metabolic muscular measurements by Near infrared spectroscopy
Time frame: weeks: 0,2,14, 26
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 29 Nov 2018.
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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.
Sofia Straudi, MD principal investigator
Ferrara Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task Oriented Circuit Training and Delayed Onset TOCT in people with Multiple Sclerosis, run by University Hospital of Ferrara at 2 sites in Italy.
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 6 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Six-Minute Walking Test (time frame: Weeks: 0,2,14, 26). 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 29 Nov 2018.