MUSCLE - Nordic Walking in MUltiple SCLErosis

NCT05385731 | Unknown DMC

• 1 other identifier: MUSCLE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Optimal Walking Speed (OPT)

  Change from baseline at 12 weeks

• Quality of life (QoL)

  Change from baseline at 12 weeks

• Cognitive function

  Change from baseline at 12 weeks

• Depressive symptoms

  Change from baseline at 12 weeks

• Expanded Disability Status Scale

  Change from baseline at 12 weeks

Other Outcomes (15)

• Balance Dynamics

  Change from baseline at 12 weeks

• Balance Static

  Change from baseline at 12 weeks

• Stride length

  Change from baseline at 12 weeks

Study Arms (3)

Nordic Walking (NWG)

EXPERIMENTAL

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); Other: Free Walking (FWG); Other: Health Education (HEG)

Free walking (FWG)

ACTIVE COMPARATOR

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); Other: Free Walking (FWG); Other: Health Education (HEG)

Health Education (HEG)

NO INTERVENTION

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

Interventions

Nordic Walking (NWG) OTHER

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Free walking (FWG); Nordic Walking (NWG)

Free Walking (FWG) OTHER

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Free walking (FWG); Nordic Walking (NWG)

Health Education (HEG) OTHER

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

Free walking (FWG); Nordic Walking (NWG)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

Related Publications (46)

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  PMID: 32694152 BACKGROUND

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  PMID: 34421801 BACKGROUND

• Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyre-Tartaruga LA, Haas AN. Can Samba and Forro 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.

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  PMID: 11154935 BACKGROUND

• Gomenuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodriguez Paz MC, Pellegrini B, Peyre-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.

  PMID: 31932999 BACKGROUND

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• 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.

  BACKGROUND

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• 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.

  BACKGROUND

• Passos-Monteiro E, B Schuch F, T Franzoni L, R Carvalho A, A Gomenuka N, Becker M, Rieder CRM, Andrade A, G Martinez F, S Pagnussat A, A Peyre-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):82. doi: 10.3390/jfmk5040082.

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• Peyre-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;18(4):1119-1127. doi: 10.1007/s11332-022-00894-4. Epub 2022 Feb 17.

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  PMID: 15674920 BACKGROUND

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• 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.

  BACKGROUND

• 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.

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• 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.

  BACKGROUND

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  BACKGROUND

• Zanardi APJ, da Silva ES, Costa RR, Passos-Monteiro E, Dos Santos IO, Kruel LFM, Peyre-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.

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  PMID: 28017241 RESULT

• Casal MZ, Peyre-Tartaruga LA, Zanardi APJ, Ivaniski-Mello A, Alves LL, Haas AN, Martinez FG. Postural Adjustments and Biomechanics During Gait Initiation and Obstacle Negotiation: A Comparison Between Akinetic-Rigid and Hyperkinetic Parkinson's Disease. Front Physiol. 2021 Nov 4;12:723628. doi: 10.3389/fphys.2021.723628. eCollection 2021.

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MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis; Movement Disorders

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind (Investigator, Outcomes Assessor, Care Provider)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 Record Dates

• First Submitted: February 17, 2022
• First Posted: May 23, 2022
• Study Start: August 2, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2024
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)