Clinical trial NCT06312046: Motor-cognitive Performance in People With Multiple Sclerosis
Official title: Motor-cognitive Performance in People With Multiple Sclerosis - Brain Activity and Effects of Balance Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Postural Balance
Keywords: Balance
Exercise
Multiple sclerosis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2024-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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: Having a neurological disease such as multiple sclerosis (MS) leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.

The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS (HiBalance-MS). This program was recently tested and found feasible in a pilot study. The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of the program. The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life.

Detailed description: Everyday living means being in complex environments and performing complex activities which usually consist of and require a combination of motor and cognitive skills. Having a neurological disease such as multiple sclerosis (MS) compromises the motor-cognitive performance. This leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.

The investigators have, in a co-design process with stakeholders, adapted a HiBalance program, originally developed by the Franzén research group for people with Parkinson's disease and combining motor-cognitive exercises in a progressively more difficult manner (HiBalance-PD), to a program specifically developed to MS (HiBalance-MS). The developed HiBalance-MS program was recently tested and found feasible in a pilot study (results published 2023). The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of a highly challenging balance training program (HiBalance-MS) on physical and cognitive functioning, and activity performance, in this group. The results will have immediate application and clinical relevance. With improved balance control people with MS will also gain other health benefits related to an active lifestyle and a better everyday life.

The hypothesis that motor-cognitive performance is reduced and impact activity performance in people with MS. They also hypothesize that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life.

Participants will be recruited through Karolinska University Hospital, through physiotherapists and physicians specialized in neurology in Stockholm and via advertisement in newspapers and the patient organization NEURO Sweden. According to earlier power calculations for detecting effects in balance and gait measures after this particular intervention, the investigators anticipate 40 to 50 participants in each group to detect significant changes.

The HiBalance-MS program is based on scientifically well-established principles of exercise training and postural control. It will be conducted as a progressive individually adjusted group training to challenge the specific balance deficit of every participant. Four main sub-systems underlying balance control (stability limits, anticipatory postural adjustments, sensory integration and motor agility) are used to target specific balance impairments. To ensure highly challenging exercises, each task is individually adjusted. Daily variation in capacity will be rated before each training session and participants will at the end of each session rate the challenging level. The training will be performed in the clinic (Karolinska University hospital) for an hour, twice a week for 10 weeks, as a group intervention (6 to 8 participants) facilitated by two physiotherapists/trainers.

Eligibility criteria: Inclusion Criteria:

* an MS diagnosis according to McDonald criteria;
* an overall MS-disability score from 2.0 to 5.5 according to the Expanded Disability Status Scale;
* ability to walk 100 m without aid;
* a maximum score of 24 in the Mini-BESTest (i.e., \< 25 points)
* 18 to 65 years of age

Exclusion Criteria:

* cognitive impairment as indicated by a score \<21 in the Montreal Cognitive Assessment;
* presence of other conditions that would substantially influence balance;
* an MS relapse or change of disease-modifying treatment within the past 8 weeks

Primary outcomes:
measure: Mini Balance Evaluation Systems test.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
Secondary outcomes:
measure: 10-Meter Walk Test, maximum speed.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: 10-Meter Walk Test, self-selected speed.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: 2-Minute Walk Test, self-selected speed.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Gait speed during simultaneous dual task performance.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Stride length during dual task gait performance.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Step time during dual task gait performance.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Response errors in dual task cognitive performance
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Reaction time in dual task cognitive performance
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Six-Spot Step Test.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Completion time in the Trail Making Test.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Number of errors in the Trail Making Test.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Immediate and delayed recall in the Ray Auditory Verbal Learning Test.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Cognitive processing speed in the Symbol Digit Modalities Test.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Cognitive function - composite measure of three cognitive tests.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Physical activity level.
timeFrame: Pre-and-post-intervention over four to seven days when awake.
measure: Physical activity level, self-reported.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Physical exercise habits, self-reported.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: The generic Walk-12 questionnaire.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Falls Efficacy Scale - International.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Assesment of anxiety with the Hospital Anxiety and Depression Scale.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Assesment of depression with the Hospital Anxiety and Depression Scale.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Modified Fatigue Impact Scale.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Occupational Gap Questionnaire.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Acceptance of Chronic Health Condition scale.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Multiple Sclerosis Impact Scale - physical impact.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Multiple Sclerosis Impact Scale - psychological impact.
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Euroqol-5 Dimensions-5 Level (EuroQoL-5D-5L).
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: Euroqol Visual Analogue Scale (EQ VAS).
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
measure: World Health Organization Disability Assessment Schedule, version 2.0. (WHODAS 2.0)
timeFrame: Pre intervention baseline and post intervention at 10 weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet, org.nr 202100-2973
name: Sverker Johansson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: