MUSCLE - Nordic Walking in MUltiple SCLErosis

Study Overview
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Brief Summary
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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
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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).

Official Title
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MUSCLE - Nordic and Free Walking in People With Multiple Sclerosis: Clinical-functional, Motor Control, and Gait Analysis Findings: a Randomized Controlled Multicentre Clinical Trials

Conditions
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Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive

Intervention / Treatment
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* Other: Nordic Walking (NWG)
* Other: Free Walking (FWG)
* Other: Health Education (HEG)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nordic Walking (NWG)<br>The Nordic Walk program consists of 3 moments: warm-up, walk, and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed - SSWS (3 'SSWS), then walk according to the training cycle, the intensity will be between 60 to 80% of the Heart of Ratio reserve. In addition, the intensity of the classes will be measured in each phase by the Borg Scale of Perceived Exertion. | Other: Nordic Walking (NWG)<br>* 24 sessions will be held twice a week, with each session taking an average of 60 minutes.<br>Other: Free Walking (FWG)<br>* 24 sessions will be held twice a week, with each session taking an average of 60 minutes.<br>Other: Health Education (HEG)<br>* The control group will receive orientation and carry out the Health Education program and will have a duration of 3 months.<br>|
| Active Comparator: Free walking (FWG)<br>The free walking program consists of 3 moments: warm-up, walk, and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed - SSWS (3 'SSWS), then walk according to the training cycle, the intensity will be between 60 to 80% of the Heart of Ratio reserve. In addition, the intensity of the classes will be measured in each phase by the Borg Scale of Perceived Exertion. Intervention administered: 24 sessions will be held twice a week, with each session taking an average of 60 minutes. | Other: Nordic Walking (NWG)<br>* 24 sessions will be held twice a week, with each session taking an average of 60 minutes.<br>Other: Free Walking (FWG)<br>* 24 sessions will be held twice a week, with each session taking an average of 60 minutes.<br>Other: Health Education (HEG)<br>* The control group will receive orientation and carry out the Health Education program and will have a duration of 3 months.<br>|
| No Intervention: Health Education (HEG)<br>The control group will receive orientation and carry out the Health Education program and will have a duration of 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test Timed Up and Go | Test Timed Up and Go: This test evaluates the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS) [Time Frame: Change from baseline at 12 weeks] | Change from baseline at 12 weeks | 
| Locomotor Rehabilitation Index | The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt). | Change from baseline at 12 weeks | 
| Self-selected walking speed | SSWS This outcome will be measure in test of treadmill walking | Change from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Walking Speed (OPT) | Optimal Walking Speed (OPT) This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill. | Change from baseline at 12 weeks | 
| Quality of life (QoL) | Quality of life (QoL) The quality of life will be estimated using the World Health Organization Quality of Life. (WHOQOL-short domains: physical, psychological, social relationships, environment, and general quality of life) and (WHOQOL-Long domains: sensory abilities, autonomy, Past. Present and Future Activities, social participation, death and dying, intimacy, and general quality of life). | Change from baseline at 12 weeks | 
| Cognitive function | Cognitive function This outcome will be measure for Montreal Cognitive Assessment (MoCA). | Change from baseline at 12 weeks | 
| Depressive symptoms | This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, Do the patient feel that their life is empty?, Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms. | Change from baseline at 12 weeks | 
| Expanded Disability Status Scale | The Expanded Disability Status Scale is the most appropriate to assess evolution and point to a new relapse. The Expanded Disability Status Scale has been the most commonly used. It has twenty items with scores ranging from 0 to 10, with the score increasing by half a point according to the patient's degree of disability, giving more focus on the patient's ability to walk (especially in scores above 4.0). | Change from baseline at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobility, Functionality, Movement disorders, Rehabilitation, Locomotion, Gait kinematics, Electromyographic activity, Quality of life