Intensive Multimodal Training for Persons With MS

NCT ID: NCT03271125

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-08

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.

Conditions

Rehabilitation; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treadmill group

Participants in the experimental group received supervised treadmill training

Group Type: EXPERIMENTAL

Treadmill

Intervention Type: BEHAVIORAL

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 group

Participants in the control group were treated with Resistance exercises.

Group Type: ACTIVE_COMPARATOR

Resistance

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Don Carlo Gnocchi IRCCS

Milan, MI, Italy

Countries

Italy

Other Identifiers

Treadmill MS

Identifier Type: -

Identifier Source: org_study_id