Clinical trial NCT05385731: MUSCLE - Nordic Walking in MUltiple SCLErosis
Official title: MUSCLE - Nordic and Free Walking in People With Multiple Sclerosis: Clinical-functional, Motor Control, and Gait Analysis Findings: a Randomized Controlled Multicentre Clinical Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Secondary Progressive
Keywords: Mobility
Functionality
Movement disorders
Rehabilitation
Locomotion
Gait kinematics
Electromyographic activity
Quality of life
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Aline Nogueira Haas
name: Flávia Gomes Martinez
First posted: 2022-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Type: Interventional, Randomized controlled multicenter clinical trial In this research, four groups of patients with Parkinson's disease will receive intervention during 4 months of different physical therapy programs (Nordic walking) and free walking, who will receive telephone guidance for performing home-based exercises. The training programs will have a duration of 4 months and will be periodized so that the duration of the sessions is matched between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by the heart rate, with predetermined series durations. All training programs will have a frequency of two sessions per week and a duration of 60 minutes. In order to evaluate the effects of the training, evaluations will be performed before and after the training period: 1) Basal (month 0): initial pre-training evaluation; 2) month 4: Evaluation 48h after the last training session.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to analyze the effects of Nordic Walking and free walking in the clinical-functional, postural balance, motor control, muscular echographic quality, and gait analysis (pendulum gait mechanism), in people with Multiple Sclerosis.

Detailed description: Objective: Analyze the effects of Nordic Walking and free walking in the clinical-functional parameters, postural balance, muscular echography quality, pendulum gait mechanism, in people with Multiple sclerosis. Experimental Design: Randomized controlled multicenter clinical trial with translational study characteristics. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Brazil, and University of Pavia, on Department of Public Health, Experimental Medicine and Forensic Sciences, Pavia, Italy. Participants: 60 patients from the Unified Health System (UHS) of both sexes, from 20 to 75 years old, diagnosed with multiple sclerosis, sedentary. Interventions: In this research, four groups of patients with multiple sclerosis will receive intervention during 4 months of different physical therapy programs (Nordic walking and free walking), who will receive telephone guidance for performing home-based exercises. The training programs will have a duration of 3 months and will be periodized so that the duration of the sessions is matched between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by the heart rate, with predetermined series durations. All training programs will have a frequency of two sessions per week and a duration of 60 minutes. To evaluate the effects of the training, evaluations will be performed before and after the training period: 1) Basal (month 0): initial pre-training evaluation; 2) month 4: Evaluation 48h after the last training session. Outcomes: clinical-functional parameters, postural balance, muscular echography quality, pendulum gait mechanism, and biochemistry. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05. Expected Results: The intervention groups of the Nordic walking are expected to be more effective in all outcomes analyzed, especially improving functional mobility when compared to the control group of unsupervised home exercises. In addition, it is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social, and environmental fields and that they will be implemented in the Unified Health System (UHS).

Eligibility criteria: Inclusion Criteria:

* volunteers aged over 20 years;
* of both sexes;
* with a clinical diagnosis of multiple sclerosis.

Exclusion Criteria:

* severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
* stroke or other associated neurological diseases; insanity;
* prostheses in the lower limbs;
* without ambulation conditions.

Primary outcomes:
measure: Test Timed Up and Go
timeFrame: Change from baseline at 12 weeks
measure: Locomotor Rehabilitation Index
timeFrame: Change from baseline at 12 weeks
measure: Self-selected walking speed
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Optimal Walking Speed (OPT)
timeFrame: Change from baseline at 12 weeks
measure: Quality of life (QoL)
timeFrame: Change from baseline at 12 weeks
measure: Cognitive function
timeFrame: Change from baseline at 12 weeks
measure: Depressive symptoms
timeFrame: Change from baseline at 12 weeks
measure: Expanded Disability Status Scale
timeFrame: Change from baseline at 12 weeks
Other outcomes:
measure: Balance Dynamics
timeFrame: Change from baseline at 12 weeks
measure: Balance Static
timeFrame: Change from baseline at 12 weeks
measure: Stride length
timeFrame: Change from baseline at 12 weeks
measure: Dynamics Stability
timeFrame: Change from baseline at 12 weeks
measure: Electromyographic activity
timeFrame: Change from baseline at 12 weeks
measure: Motor behavior by electromyographic activity
timeFrame: Change from baseline at 12 weeks
measure: Muscular activation
timeFrame: Change from baseline at 12 weeks
measure: Internal Work
timeFrame: Change from baseline at 12 weeks
measure: External Work
timeFrame: Change from baseline at 12 weeks
measure: total mechanical work
timeFrame: Change from baseline at 12 weeks
measure: Pendulum-like Recovery
timeFrame: Change from baseline at 12 weeks
measure: Scapular and pelvis coordination
timeFrame: Change from baseline at 12 weeks
measure: Range of motion
timeFrame: Change from baseline at 12 weeks
measure: Psychological parameters - Profile of Mood State
timeFrame: Change from baseline at 12 weeks
measure: Quality of sleep - The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline at 12 weeks
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
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