Viewing Study NCT06436131



Ignite Creation Date: 2024-06-16 @ 11:49 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06436131
Status: COMPLETED
Last Update Posted: 2024-05-30
First Post: 2024-03-19

Brief Title: The Effects of In-phase Bilateral Exercise in People with Progressive Multiple Sclerosis
Sponsor: Cyprus University of Technology
Organization: Cyprus University of Technology

Study Overview

Official Title: The Effects of In-phase Bilateral Exercise on Cognitive and Motor Outcome Measures in Patients with Progressive Multiple Sclerosis a Randomized Control Trial
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 sessionsweek 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
Detailed Description: The term progressive multiple sclerosis MS includes both secondary progressive MS SPMS and primary progressive MS PPMS As it is well known the course of MS is highly variable On one hand almost 50 of the patients who is characterized by the relapsing remitting MS after 10-15 years of disease this pattern becomes progressive in which individual clinical symptoms slowly progress a disease type defined as a SPMS On the other hand in about 15 of people with MS disease progression is persistent from onset defined as a PPMS Patients with progressive MS except from physical impairment often have cognitive dysfunctions which negatively affect quality of life Information processing speed is the most common cognitive deficit between people with PPMS and those with SPMS

Despite the fact that cognitive rehabilitation approaches are effective in treating MS-related cognitive dysfunctions there are evidence from several studies which indicated the impact of different types of exercises in the improvement of cognitive in people with MS Furthermore evidences from previous studies in healthy and people with MS reported a close relationship between cognitive functions and upper limbs performance defined by the projections from the Anterior Cingulate Cortex to the motor cortex and spinal cord Specifically the decline of information processing speed indicates reduction of manual dexterity in people with MS Manual dexterity is defined as the manual skill which contains coordination of fine and gross voluntary movements of the upper limbs Manual dexterity dysfunction in MS contributes to reduced ability to perform activities of daily living ADLs and social activities which causes reduction of independency and quality of life

Moreover evidence from previous studies reported that in-phase bilateral movements needs less attentional load and less neural control than the unilateral or the other types of bilateral coordination as a result to perform the specific type of movement ie in-phase bilateral more efficient and more easy Therefore given that patients with progressive MS characterized by decline of information processing speed which affects manual dexterity a reasonable question arises whether in-phase bilateral upper limbs exercises will improve information processing speed and thus to improve manual dexterity in the specific clinical cohort

The aim of the current study was to investigate primarily the hypothesis that a 12-week exercise program based on in-phase bilateral upper limbs movements based on sport activities and functional training could improve information processing speed compared to a conservative type of exercise in people with progressive MS A secondary aim was to evaluate whether the specific exercise program could improve manual dexterity and have a correlation with information processing speed

Second aim of the study was to investigate the effects of the specific type of exercises on various clinical symptoms fatigue and on quality of life using clinical assessment tools and subjective questionnaires

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None