Clinical trial NCT03271125: Intensive Multimodal Training for Persons With MS
Official title: Intensive Multimodal Training for Persons With Multiple Sclerosis: Random Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Multiple Sclerosis
Keywords: Intervention
Multiple sclerosis
Treadmill
Mobility
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative multimodal training protocol carried out on treadmill on walking efficacy, mobility, balance, executive function, fatigue and health-related quality of life in a sample of persons with moderate to severe MS deficit of mobility compared to a control group that received a strengthening program of similar intensity.

Detailed description: Persons with multiple sclerosis can have various deficits, affecting many aspects of physical and cognitive functioning often leading to low levels of physical activity in daily life. These include poor endurance, muscle weakness, incoordination and poor balance and cognitive deficits that can all lead to persistent mobility difficulties in daily life.

Given the importance of exercise and physical activity for persons with multiple sclerosis that are already moderately to severely hampered by their locomotor ability and balance, the setting up of intense functional mobility training that targets the main deficits, in adjunction to a clinical rehabilitation usual care and under close supervision, may be a viable way of increasing the level of physiological health and give a basis for the persons to start their own activity pursuit outside of the rehabilitation clinic. Treadmill walking has several benefits for mobility rehabilitation. First, it is a everyday task, walking. Second it lends itself well to a dual task paradigm where other aspects of mobility, such as equilibrium and cognitive factors can be addressed during walking. Third, even persons with severe walking limitations can train walking at various speeds when on treadmill, holding onto handrails and using safety harnesses that minimize the possibility of adverse events during training. Further, the treadmill paradigm lends itself well to training with progressive task difficulty, numerous rhythmic repetitions, and importantly it can include an aerobic component to improve cardiorespiratory fitness. All of which should lead to improved submaximal exercise tolerance and endurance, more functional mobility and consequently increased ability to carry out activities of daily living.

Methods: A consecutive sample of 42 People with Multiple Sclerosis (PwMS) were recruited from the outpatient/inpatient rehabilitation service of the Don Gnocchi Foundation. The study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of the Don Gnocchi Foundation. Subjects signed an informed consent form before the beginning of the study.

The study design was a two arm randomized 2:1 controlled trial (see study flow chart in Figure 1).

The participants were assessed before and after the rehabilitation period by researchers blinded to group assignment.

Participants in both groups received 15- 20 treatments sessions lasting 30 minutes 5 times per week by experienced physical therapists trained for the study. All participants also followed their usual rehabilitation care protocols as planned.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis according to McDonald's criteria (Polman et al. Ann Neurology 2011)
* EDSS score \<= 7
* Free from relapses and steroid treatment for at least 1 month)
* Able to stand 30 seconds,
* Able to walk at least 10 meters independently or with a cane
* Able to understand and follow instructions
* Stable neurological conditions and willingness to participate in the study.

Exclusion Criteria:

* Cardiac pacemaker
* Any pre-existing conditions that affected walking function
* diagnosis of depression or psychotic disorder

Primary outcomes:
measure: Two minute walking test
timeFrame: Two minutes
measure: Timed up and go test
timeFrame: 1 minute
Secondary outcomes:
measure: The Frontal Assessment Battery
timeFrame: 10 minutes
measure: Ten meter walking test
timeFrame: 2 minutes
measure: The Berg Balance Scale
timeFrame: 15 minutes
measure: Dynamic Gait Index
timeFrame: 15 minutes
measure: The Short Form-12 questionnaire (SF-12)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Carlo Gnocchi IRCCS
state: MI
Study officials:
References: