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MUSCLE - Nordic Walking in MUltiple SCLErosis (MUSCLE)

Primary Purpose

Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Multiple Sclerosis, Primary Progressive

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nordic Walking (NWG)
Free Walking (FWG)
Health Education (HEG)
Sponsored by
Leonardo A. Peyré-Tartaruga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Chronic Progressive focused on measuring Mobility, Functionality, Movement disorders, Rehabilitation, Locomotion, Gait kinematics, Electromyographic activity, Quality of life

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Nordic Walking (NWG)

Free walking (FWG)

Health Education (HEG)

Arm Description

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.

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.

The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.

Outcomes

Primary Outcome Measures

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]
Locomotor Rehabilitation Index
The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt).
Self-selected walking speed
SSWS This outcome will be measure in test of treadmill walking

Secondary Outcome Measures

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.
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).
Cognitive function
Cognitive function This outcome will be measure for Montreal Cognitive Assessment (MoCA).
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.
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).

Full Information

First Posted
February 17, 2022
Last Updated
May 17, 2022
Sponsor
Leonardo A. Peyré-Tartaruga
Collaborators
Aline Nogueira Haas, Flávia Gomes Martinez
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1. Study Identification

Unique Protocol Identification Number
NCT05385731
Brief Title
MUSCLE - Nordic Walking in MUltiple SCLErosis
Acronym
MUSCLE
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leonardo A. Peyré-Tartaruga
Collaborators
Aline Nogueira Haas, Flávia Gomes Martinez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind (Investigator, Outcomes Assessor, Care Provider)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nordic Walking (NWG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Free walking (FWG)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Health Education (HEG)
Arm Type
No Intervention
Arm Description
The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.
Intervention Type
Other
Intervention Name(s)
Nordic Walking (NWG)
Intervention Description
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Intervention Type
Other
Intervention Name(s)
Free Walking (FWG)
Intervention Description
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Intervention Type
Other
Intervention Name(s)
Health Education (HEG)
Intervention Description
The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.
Primary Outcome Measure Information:
Title
Test Timed Up and Go
Description
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]
Time Frame
Change from baseline at 12 weeks
Title
Locomotor Rehabilitation Index
Description
The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt).
Time Frame
Change from baseline at 12 weeks
Title
Self-selected walking speed
Description
SSWS This outcome will be measure in test of treadmill walking
Time Frame
Change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Optimal Walking Speed (OPT)
Description
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.
Time Frame
Change from baseline at 12 weeks
Title
Quality of life (QoL)
Description
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).
Time Frame
Change from baseline at 12 weeks
Title
Cognitive function
Description
Cognitive function This outcome will be measure for Montreal Cognitive Assessment (MoCA).
Time Frame
Change from baseline at 12 weeks
Title
Depressive symptoms
Description
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.
Time Frame
Change from baseline at 12 weeks
Title
Expanded Disability Status Scale
Description
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).
Time Frame
Change from baseline at 12 weeks
Other Pre-specified Outcome Measures:
Title
Balance Dynamics
Description
Balance Dynamics: This outcome will be evaluated using Berg Balance Scale (BBS). This scale assessment of the individual's balance in 14 situations, representative of activities of the day to day, such as: stand up, get up, walk, to lean forward, to move, to turn, among others. The maximum score of a being reached of 56 points and each item has an ordinal scale of five alternatives ranging from 0 to 4 points, according to the degree of difficulty.
Time Frame
Change from baseline at 12 weeks
Title
Balance Static
Description
Balance Static: This outcome will be evaluated using area of center of pressure (cm squared).
Time Frame
Change from baseline at 12 weeks
Title
Stride length
Description
Stride Length (in meters). 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 at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed (in kilometers/hours).
Time Frame
Change from baseline at 12 weeks
Title
Dynamics Stability
Description
This outcome is calculated as the inter-strides variation in terms of coefficient of variation of stride frequency.
Time Frame
Change from baseline at 12 weeks
Title
Electromyographic activity
Description
This outcome is measure is the mean amplitude (in millivolts) of the muscles: vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using an electromyograph. In of the walking test on treadmill at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed.
Time Frame
Change from baseline at 12 weeks
Title
Motor behavior by electromyographic activity
Description
During the gait initiation, the investigators will evaluate the anticipatory postural adjustments. The electromyograph will be used to obtain electromyographic activity data of the spinal erector muscles, internal oblique, gluteus medius, rectus femoris, femoral biceps, medial gastrocnemius and tibialis anterior (in mV). All these parameters will be measured before and after Nordic and free walking interventions.
Time Frame
Change from baseline at 12 weeks
Title
Muscular activation
Description
Muscular activation:Muscular activation during phases of the gait cycle of people with Parkinson's disease through the electromyographic evaluation of the muscles of the spinal erector, internal oblique, gluteus medius, rectus femoris, femoral biceps, anterior tibialis and medial gastrocnemius during treadmill running. All participants will walk on a treadmill at selected walking speed. To identify electromyographic activity during the different gait cycles, the electromyograph will be synchronized with VICON (Vicon Motion Capture System - Oxford - USA, 1984). All these parameters will be measured before and after Nordic and free walking interventions.
Time Frame
Change from baseline at 12 weeks
Title
Internal Work
Description
The internal work is the mechanical energy fluctuations of the movement of limbs relative to the center of body mass (Wint, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill. All these parameters will be measured before and after Nordic and free walking interventions.
Time Frame
Change from baseline at 12 weeks
Title
External Work
Description
The external work is energy fluctuations of the center of body mass with respect to the external environment or surroundings (Wext, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill. All these parameters will be measured before and after Nordic and free walking interventions.
Time Frame
Change from baseline at 12 weeks
Title
total mechanical work
Description
The total mechanical work (Wtot =Wext + Wint) produced by a body during activity. These outcomes are measured by composite for:(external, internal mechanical work, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill. All these parameters will be measured before and after Nordic and free walking interventions.
Time Frame
Change from baseline at 12 weeks
Title
Pendulum-like Recovery
Description
The mechanical energy exchange of the center of mass is quantified by the calculation of the percentage of reconversion of mechanical energy, called Recovery (R), which counts the form that the mechanical energy is saved through the pendulum mechanism of the locomotion. This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill. This parameter will be measured before and after Nordic and free walking interventions.
Time Frame
Change from baseline at 12 weeks
Title
Scapular and pelvis coordination
Description
The scapular girdle movement in angles will be measure, pelvic girdle in angles will be measure. The scapular girdle movement in angles will be aggregated to pelvic girdle in angles to arrive at continuous phases relation in angle. This parameter will be measured before and after Nordic and free walking interventions.
Time Frame
Change from baseline at 12 weeks
Title
Range of motion
Description
Range of motion (in degrees) of the following segments and joints: Tilt pelvic, sagittal flexion of trunk, hip flexion, knee flexion, ankle flexion, shoulder flexion, shoulder abduction, elbow flexion. All these parameters will be measured before and after Nordic and free walking interventions.
Time Frame
Change from baseline at 12 weeks
Title
Psychological parameters - Profile of Mood State
Description
This variable will be measure by the Brunel Mood Scale (BRUMS) that was developed to provide a quick assessment of mood states adult populations. The BRUMS has been demonstrated to have Cronbach alpha values above 0.70 and is a reliable tool used to measure the mood of Brazilian athletes. The instrument consisted of 24 items and six subscales assessing mood: tension, depression, anger, vigor, fatigue and confusion. Each item was rated on a Likert scale ranging from nothing (0) to extremely (4), where the respondent indicated how they were feeling at that moment. The results were calculated using the mean of the items in each subscale.
Time Frame
Change from baseline at 12 weeks
Title
Quality of sleep - The Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI consists of 24 questions or items to be rated (0-3 for 20 items while 4 items are open-ended), 19 of which are self-reported and 5 of which require secondary feedback from a room or bed partner. Only the self-reported items (15 rated as 0-3 while 4 open-ended) are used for quantitative evaluation of sleep quality as perceived by the patient. The open-ended items are also finally scored as structured categorical values (rated at 0-3) as per the range of values reported for them by the patient. These 19 self-reported items are used to generate categorical scores representing the PSQI's 7 components. The individual component scores each assess a specific feature of sleep. Finally, the scores for each component are summed to get a total score, also termed the global score (range: 0 to 21). This score provides a summary of the respondent's sleep experience and quality for the past month.
Time Frame
Change from baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90690-200
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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MUSCLE - Nordic Walking in MUltiple SCLErosis

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