The Effects of In-phase Bilateral Exercise in People with Progressive Multiple Sclerosis

NCT06436131 | Completed

• 1 other identifier: IBEPMS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system. MS, typical presents with progression of clinical symptoms which mainly include motor and cognitive impairment, as well as reduction of patients' quality of life. Exercise is an effective approach in the management of the symptoms in people with progressive MS. Previous studies in healthy and in people with MS, reported a close relationship between cognitive functions and upper limb performance. Since patients with progressive MS facing difficulties with performing complex exercises due to cognitive dysfunctions and given the close relationship between cognitive functions and manual dexterity, a reasonable question arises whether a type of upper limbs exercises with less cognitive demands will improve the information processing speed in people with progressive MS. The aim of the current study is to investigate the effects of in-phase bilateral upper limbs exercises on the information processing speed, in patients with progressive MS, given that in-phase bilateral movements needs less attentional load than the other types of bilateral coordination. The intervention protocol lasted for 12 consecutive weeks (30-60 minutes /session x 3 sessions/week) and included in-phase bilateral exercises of the upper limbs, adapted to different sports activities and to functional training. Results from the statistical analysis indicated improvement of the experimental group compared to the control group, on the information processing speed alongside with improvement of motor skills.

Conditions

Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive

Keywords

In-phase Bilateral; exercise; cognitive processing; multiple sclerosis; manual dexterity

Outcome Measures

Primary Outcomes (1)

• Symbol Digit Modalities Test

  It is a commonly used test in pwMS, which measures processing speed as well as motor speed. The investigators employed the oral form of the test, in which participants were provided with the test sheet with nine symbols, each paired with a number on top of the page, defined as the "key". For example, the symbol "O" is matched with the number "6", so the correct response would be "six". The rest of the page consists of a randomized, sequential variety of these symbols. Participants are asked to verbally respond with the number that corresponds with each symbol. During the test, the participant is given two minutes to orally match symbols with digits as quickly as possible. The score is obtained by subtracting the number of errors from the number of items completed. To account for practice effects, the investigators created six different tests, as many as our assessment points, in which the order of the symbols and the numbers of the "key" were rearranged

  Baseline (3 weeks) until the end of the Intervention (12 weeks)

Secondary Outcomes (6)

• Medical Outcomes Study Short Form 36

  Baseline (3rd week) until the end of the Intervention (12 weeks)

• Modified Fatigue Impact Scale

  Baseline (3rd week) until the end of the Intervention (12 weeks)

• Trail Making Test

  Baseline (3 weeks) until the end of the Intervention (12 weeks)

• Purdue Pegboard Test

  Baseline (3 weeks) until the end of the Intervention (12 weeks)

• Timed 25-Foot Walk

  Baseline (3 weeks) until the end of the Intervention (12 weeks)

Study Arms (2)

IBPMS

EXPERIMENTAL

The exercise program of the experimental group consisted of exercises based on in-phase bilateral movements of the upper and lower limbs, which they were adapted to different sport activities and to fitness functional exercises. The specific exercise program was organized in a group circuit training, performed simultaneously on each session from all the participants of the experimental group, considering the MS exercise recommendations. Specifically, the program included sports activities of basic technical skills of basketball (e.g., different types of passing, catching and throwing the ball) and volleyball (e.g., different types of passing and receiving the ball), whereas the fitness exercises included the diagonal movements from proprioceptive neuromuscular facilitation technique, by the use of a resistance bands.

Behavioral: In-phase Bilateral Exercise

Controls

ACTIVE COMPARATOR

The participants of the active control group, underwent an exercise program based on conventional exercises, such as strengthening of the major muscle groups of the trunk, resistance exercises for the upper and lower limbs and body weight support treadmill exercise. All participants of the active control group performed the specific types of exercises individually, as opposed with the experimental group which was organized as a group training. Controls performed the specific type exercises once a week, for 12 consecutive weeks.

Behavioral: Conservative exercises

Interventions

In-phase Bilateral Exercise BEHAVIORAL

The exercise program of the experimental group consisted of exercises based on in-phase bilateral movements of the upper and lower limbs, which were adapted to different sport activities and to fitness functional exercises. The participants of experimental group performed the specific type exercises three times per week, for 12 consecutive weeks.

IBPMS

Conservative exercises BEHAVIORAL

The participants of the active control group, underwent an exercise program based on conventional exercises, such as strengthening of the major muscle groups of the trunk, resistance exercises for the upper and lower limbs and body weight support treadmill exercise.

Controls

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of progressive multiple sclerosis (MS) (primary or/and secondary progressive MS)
• Expanded Disability Status Scale score between three and six
• no relapse within 30 days
• aged between 30 and 70 years
• Mini Mental State of Examination score between 20 and 30 (mild to no cognitive impairment)

You may not qualify if:

• history of any disease affecting the central nervous system other than MS (e.g., stroke, Parkinson's disease, cerebral palsy)
• history of cardiovascular disease (e.g., known aneurism, myocardial infarction, hyper/hypotension, heart failure)
• severe orthopaedic disorders (e.g., knee or hip replacement, spondylosurgery, disk herniation, recent bone fracture)
• mental disorders (e.g., depression, schizophrenia, bipolar syndrome)
• pregnancy during the implementation of the study timeline
• hearing impairments (i.e., deafness)
• visual deficit (e.g., optic neuritis, blindness, diplopia, glaucoma, blurred vision)
• history of epileptic seizures
• spasticity level on upper or lower limbs more than 1+ (slight increase in muscle tone) according to Modified Ashworth Scale

Sponsors & Collaborators

• Cyprus University of Technology: lead
• Cyprus Institute of Neurology and Genetics: collaborator

Study Sites (1)

Dimitris Sokratous

Limassol, 3036, Cyprus

Location

Related Publications (6)

• DeLuca J, Chiaravalloti ND, Sandroff BM. Treatment and management of cognitive dysfunction in patients with multiple sclerosis. Nat Rev Neurol. 2020 Jun;16(6):319-332. doi: 10.1038/s41582-020-0355-1. Epub 2020 May 5.

  PMID: 32372033 BACKGROUND

• Bush G, Luu P, Posner MI. Cognitive and emotional influences in anterior cingulate cortex. Trends Cogn Sci. 2000 Jun;4(6):215-222. doi: 10.1016/s1364-6613(00)01483-2.

  PMID: 10827444 BACKGROUND

• Paus T. Primate anterior cingulate cortex: where motor control, drive and cognition interface. Nat Rev Neurosci. 2001 Jun;2(6):417-24. doi: 10.1038/35077500.

  PMID: 11389475 BACKGROUND

• Grefkes C, Eickhoff SB, Nowak DA, Dafotakis M, Fink GR. Dynamic intra- and interhemispheric interactions during unilateral and bilateral hand movements assessed with fMRI and DCM. Neuroimage. 2008 Jul 15;41(4):1382-94. doi: 10.1016/j.neuroimage.2008.03.048. Epub 2008 Apr 8.

  PMID: 18486490 BACKGROUND

• Swinnen SP, Wenderoth N. Two hands, one brain: cognitive neuroscience of bimanual skill. Trends Cogn Sci. 2004 Jan;8(1):18-25. doi: 10.1016/j.tics.2003.10.017.

  PMID: 14697399 BACKGROUND

• Sokratous D, Charalambous CC, Papanicolaou EZ, Michailidou K, Konstantinou N. Investigation of in-phase bilateral exercise effects on corticospinal plasticity in relapsing remitting multiple sclerosis: A registered report single-case concurrent multiple baseline design across five subjects. PLoS One. 2023 Mar 2;18(3):e0272114. doi: 10.1371/journal.pone.0272114. eCollection 2023.

  PMID: 36862693 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Motor Activity; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Dimitris Sokratous

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: It was a double-blind study in which neither the participants nor the assessor and the trainer knew who's been assigned to either group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects were randomized in two groups. Experimental group received an exercise program based on in-phase bilateral exercises, whereas the active control group receives conservative exercises. The duration of the study was 12 consecutive weeks for both groups.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: May 30, 2024
• Study Start: October 2, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When summary data are published then all Data will be available
• Access Criteria: Raw data will available for any scientist who wants to analyze or for reproducibility

Locations

CY (1)