Intensive Multimodal Training for Persons With MS

Multiple Sclerosis Clinical Trial

— Treadmill  

Official title:

Intensive Multimodal Training for Persons With Multiple Sclerosis: Random Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271125
• Other study ID #: Treadmill MS
• Status: Completed
• Phase: N/A
• First received: August 31, 2017
• Last updated: August 31, 2017
• Start date: January 8, 2013

Study information

• Verified date: August 2017
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: May 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Rehabilitation
• Sclerosis

Intervention

Behavioral:
• Treadmill
Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.
• Resistance
Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi IRCCS	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two minute walking test	The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.	Two minutes
Primary	Timed up and go test	The Timed Up & Go test (TUG) is a simple functional test that requires a person to stand up, walk 3m, turn back, and sit down again while being timed.	1 minute
Secondary	The Frontal Assessment Battery	The Frontal Assessment Battery (FAB) is a short cognitive and behavioral six-subtest battery for the bedside screening of a global executive dysfunction.	10 minutes
Secondary	Ten meter walking test	The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.	2 minutes
Secondary	The Berg Balance Scale	The Berg Balance Scale (BBS) is a 14-item scale widely used to assess balance disorders in PwMS. BBS provides information about patient's balance-related abilities.	15 minutes
Secondary	Dynamic Gait Index	The Dynamic Gait Index (DGI) measures gait function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects, and going upstairs.	15 minutes
Secondary	The Short Form-12 questionnaire (SF-12)	The SF12 is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant.	10 minutes