MUSCLE - Nordic Walking in MUltiple SCLErosis

• Sponsor: Leonardo A. Peyré-Tartaruga (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05385731
• Collaborator: Aline Nogueira Haas (Other), Flávia Gomes Martinez (Other)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 28.9
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive	Other: Nordic Walking (NWG); Other: Free Walking (FWG); Other: Health Education (HEG)	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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 (Care Provider, Investigator, Outcomes Assessor)
• Masking Description: double-blind (Investigator, Outcomes Assessor, Care Provider)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 2, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nordic Walking (NWG) 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); 24 sessions will be held twice a week, with each session taking an average of 60 minutes.; Other: Free Walking (FWG); 24 sessions will be held twice a week, with each session taking an average of 60 minutes.; Other: Health Education (HEG); The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.
Active Comparator: Free walking (FWG) 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); 24 sessions will be held twice a week, with each session taking an average of 60 minutes.; Other: Free Walking (FWG); 24 sessions will be held twice a week, with each session taking an average of 60 minutes.; Other: Health Education (HEG); The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.
No Intervention: Health Education (HEG) The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.

Outcome Measures

Primary Outcome Measures

1. Test Timed Up and Go [Change from baseline at 12 weeks]

   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]

2. Locomotor Rehabilitation Index [Change from baseline at 12 weeks]

   The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt).

3. Self-selected walking speed [Change from baseline at 12 weeks]

   SSWS This outcome will be measure in test of treadmill walking

Secondary Outcome Measures

1. Optimal Walking Speed (OPT) [Change from baseline at 12 weeks]

   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.

2. Quality of life (QoL) [Change from baseline at 12 weeks]

   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).

3. Cognitive function [Change from baseline at 12 weeks]

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

4. Depressive symptoms [Change from baseline at 12 weeks]

   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.

5. Expanded Disability Status Scale [Change from baseline at 12 weeks]

   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).

Other Outcome Measures

1. Balance Dynamics [Change from baseline at 12 weeks]

   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.

2. Balance Static [Change from baseline at 12 weeks]

   Balance Static: This outcome will be evaluated using area of center of pressure (cm squared).

3. Stride length [Change from baseline at 12 weeks]

   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).

4. Dynamics Stability [Change from baseline at 12 weeks]

   This outcome is calculated as the inter-strides variation in terms of coefficient of variation of stride frequency.

5. Electromyographic activity [Change from baseline at 12 weeks]

   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.

6. Motor behavior by electromyographic activity [Change from baseline at 12 weeks]

   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.

7. Muscular activation [Change from baseline at 12 weeks]

   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.

8. Internal Work [Change from baseline at 12 weeks]

   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.

9. External Work [Change from baseline at 12 weeks]

   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.

10. total mechanical work [Change from baseline at 12 weeks]

    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.

11. Pendulum-like Recovery [Change from baseline at 12 weeks]

    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.

12. Scapular and pelvis coordination [Change from baseline at 12 weeks]

    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.

13. Range of motion [Change from baseline at 12 weeks]

    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.

14. Psychological parameters - Profile of Mood State [Change from baseline at 12 weeks]

    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.

15. Quality of sleep - The Pittsburgh Sleep Quality Index (PSQI) [Change from baseline at 12 weeks]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul	Brazil	90690-200

Sponsors and Collaborators

• Leonardo A. Peyré-Tartaruga
• Aline Nogueira Haas
• Flávia Gomes Martinez

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Baker NA, Tickle-Degnen L. The effectiveness of physical, psychological, and functional interventions in treating clients with multiple sclerosis: a meta-analysis. Am J Occup Ther. 2001 May-Jun;55(3):324-31.
• Balbinot G, Schuch CP, Bianchi Oliveira H, Peyré-Tartaruga LA. Mechanical and energetic determinants of impaired gait following stroke: segmental work and pendular energy transduction during treadmill walking. Biol Open. 2020 Jul 21;9(7). pii: bio051581. doi: 10.1242/bio.051581.
• Cavagna GA, Thys H, Zamboni A. The sources of external work in level walking and running. J Physiol. 1976 Nov;262(3):639-57.
• Chung KC, Song JW; WRIST Study Group. A guide to organizing a multicenter clinical trial. Plast Reconstr Surg. 2010 Aug;126(2):515-523. doi: 10.1097/PRS.0b013e3181df64fa. Review.
• Confavreux C, Vukusic S, Adeleine P. Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process. Brain. 2003 Apr;126(Pt 4):770-82.
• Correale L, Buzzachera CF, Liberali G, Codrons E, Mallucci G, Vandoni M, Montomoli C, Bergamaschi R. Effects of Combined Endurance and Resistance Training in Women With Multiple Sclerosis: A Randomized Controlled Study. Front Neurol. 2021 Aug 5;12:698460. doi: 10.3389/fneur.2021.698460. eCollection 2021.
• Detrembleur C, van den Hecke A, Dierick F. Motion of the body centre of gravity as a summary indicator of the mechanics of human pathological gait. Gait Posture. 2000 Dec;12(3):243-50.
• Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyré-Tartaruga LA, Haas AN. Can Samba and Forró Brazilian rhythmic dance be more effective than walking in improving functional mobility and spatiotemporal gait parameters in patients with Parkinson's disease? BMC Neurol. 2020 Aug 18;20(1):305. doi: 10.1186/s12883-020-01878-y.
• Gomeñuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodríguez Paz MC, Pellegrini B, Peyré-Tartaruga LA. Nordic walking training in elderly, a randomized clinical trial. Part II: Biomechanical and metabolic adaptations. Sports Med Open. 2020 Jan 13;6(1):3. doi: 10.1186/s40798-019-0228-6.
• Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski K, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Mult Scler. 2020 Oct;26(12):1459-1469. doi: 10.1177/1352458520915629. Epub 2020 Apr 23.
• MONTEIRO, Elren Passos et al. Aspectos biomecânicos da locomoção de pessoas com doença de Parkinson: revisão narrativa. Revista Brasileira de Ciências do Esporte, v. 39, p. 450-457, 2017.
• Motl RW, Sandroff BM. Benefits of Exercise Training in Multiple Sclerosis. Curr Neurol Neurosci Rep. 2015 Sep;15(9):62. doi: 10.1007/s11910-015-0585-6. Review.
• O'CONNELL, R. et al. A controlled study to assess the effects of aerobic training on patients with multiple sclerosis. 14th International World Confederation for Physical Therapy, 2003.
• Passos-Monteiro E, B Schuch F, T Franzoni L, R Carvalho A, A Gomeñuka N, Becker M, Rieder CRM, Andrade A, G Martinez F, S Pagnussat A, A Peyré-Tartaruga L. Nordic Walking and Free Walking Improve the Quality of Life, Cognitive Function, and Depressive Symptoms in Individuals with Parkinson's Disease: A Randomized Clinical Trial. J Funct Morphol Kinesiol. 2020 Nov 10;5(4). pii: E82. doi: 10.3390/jfmk5040082.
• Patti F, Ciancio MR, Cacopardo M, Reggio E, Fiorilla T, Palermo F, Reggio A, Thompson AJ. Effects of a short outpatient rehabilitation treatment on disability of multiple sclerosis patients--a randomised controlled trial. J Neurol. 2003 Jul;250(7):861-6.
• Peyré-Tartaruga LA, Martinez FG, Zanardi APJ, Casal MZ, Donida RG, Delabary MS, Passos-Monteiro E, Coertjens M, Haas AN. Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. Sport Sci Health. 2022 Feb 17:1-9. doi: 10.1007/s11332-022-00894-4. [Epub ahead of print] Review.
• Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
• Psarakis M, Greene D, Moresi M, Baker M, Stubbs P, Brodie M, Lord S, Hoang P. Impaired heel to toe progression during gait is related to reduced ankle range of motion in people with Multiple Sclerosis. Clin Biomech (Bristol, Avon). 2017 Nov;49:96-100. doi: 10.1016/j.clinbiomech.2017.08.012. Epub 2017 Sep 1.
• Reuter I, Mehnert S, Leone P, Kaps M, Oechsner M, Engelhardt M. Effects of a flexibility and relaxation programme, walking, and nordic walking on Parkinson's disease. J Aging Res. 2011;2011:232473. doi: 10.4061/2011/232473. Epub 2011 Mar 30.
• Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G. Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD003980. Review.
• Schepens B, Bastien GJ, Heglund NC, Willems PA. Mechanical work and muscular efficiency in walking children. J Exp Biol. 2004 Feb;207(Pt 4):587-96.
• SOARES, Gustavo da Silva; PEYRÉ-TARTARUGA, Leonardo Alexandre. Doença de Parkinson e exercício físico: uma revisão da literatura. Ciência em Movimento, v. 12, n. 24, p. 69-85, 2010.
• Tschentscher M, Niederseer D, Niebauer J. Health benefits of Nordic walking: a systematic review. Am J Prev Med. 2013 Jan;44(1):76-84. doi: 10.1016/j.amepre.2012.09.043. Review.
• WILLEMS, P.-A.; SCHEPENS, Bénédicte; DETREMBLEUR, Christine. Marcha normal. EMC-Kinesiterapia-Medicina Física, v. 33, n. 2, p. 1-29, 2012.
• YASINSKAYA, Yana Konstantinovna. DEVELOPMENT OF STATIC AND DYNAMIC BALANCE IN INDIVIDUALS WITH MULTIPLE SCLEROSIS BASED ON THE USE OF THE NORDIC WALKING METHOD. имени ПФ Лесгафта, n. 12, p. 320, 2014.
• Zanardi APJ, da Silva ES, Costa RR, Passos-Monteiro E, Dos Santos IO, Kruel LFM, Peyré-Tartaruga LA. Gait parameters of Parkinson's disease compared with healthy controls: a systematic review and meta-analysis. Sci Rep. 2021 Jan 12;11(1):752. doi: 10.1038/s41598-020-80768-2.

• Responsible Party: Leonardo A. Peyré-Tartaruga, Associate Professor, Federal University of Rio Grande do Sul
• ClinicalTrials.gov Identifier: NCT05385731
• Other Study ID Numbers: MUSCLE
• First Posted: May 23, 2022
• Last Update Posted: May 23, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Leonardo A. Peyré-Tartaruga, Associate Professor, Federal University of Rio Grande do Sul: Mobility; Functionality; Movement disorders; Rehabilitation; Locomotion; Gait kinematics; Electromyographic activity; Quality of life
• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis

Study Results

No Results Posted as of May 23, 2022