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Multiple Sclerosis, Chronic ProgressiveMUSCLENCT05385731

MUSCLE - Nordic Walking in MUltiple SCLErosis

A study testing Nordic Walking (NWG), Free Walking (FWG) and Health Education (HEG) in people with Multiple Sclerosis, Chronic Progressive and Multiple Sclerosis, run by Leonardo A. Peyré-Tartaruga at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Nordic Walking (NWG), Free Walking (FWG) and Health Education (HEG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
2 Aug 2022to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Federal do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90690-200

Other trials in Brazil

About this study

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

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.

Read the 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).

Being tested
Nordic Walking (NWG), Free Walking (FWG), Health Education (HEG)
Keywords
Mobility, Functionality, Movement disorders, Rehabilitation, Locomotion, Gait kinematics, Electromyographic activity, Quality of life
Medical subject headings
Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nordic Walking (NWG)Other

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

  • Free Walking (FWG)Other

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

  • 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.

Study groups in NCT05385731
Study groupRoleWhat they receive
Nordic Walking (NWG)ExperimentalThe 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.
Receives: Other: Nordic Walking (NWG); Other: Free Walking (FWG); Other: Health Education (HEG)
Free walking (FWG)Active comparatorThe 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.
Receives: Other: Nordic Walking (NWG); Other: Free Walking (FWG); Other: Health Education (HEG)
Health Education (HEG)No interventionThe control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]

    Measured: Change from baseline at 12 weeks

  2. Locomotor Rehabilitation Index

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

    Measured: Change from baseline at 12 weeks

  3. Self-selected walking speed

    SSWS This outcome will be measure in test of treadmill walking

    Measured: Change from baseline at 12 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Change from baseline at 12 weeks

  2. 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).

    Measured: Change from baseline at 12 weeks

  3. Cognitive function

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

    Measured: Change from baseline at 12 weeks

  4. 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.

    Measured: Change from baseline at 12 weeks

  5. 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).

    Measured: Change from baseline at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start2 Aug 2022 (estimated)
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05385731
Sponsor's protocol ID
MUSCLE
Acronym
MUSCLE
Status last verified
May 2022
First submitted
17 Feb 2022
Last updated
23 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Balbinot G, Schuch CP, Bianchi Oliveira H, Peyre-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):bio051581. doi: 10.1242/bio.051581.

    PubMed 32694152

  • 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. doi: 10.5014/ajot.55.3.324.

    PubMed 11723974

  • Cavagna GA, Thys H, Zamboni A. The sources of external work in level walking and running. J Physiol. 1976 Nov;262(3):639-57. doi: 10.1113/jphysiol.1976.sp011613.

    PubMed 1011078

  • 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.

    PubMed 20375760

  • 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. doi: 10.1093/brain/awg081.

    PubMed 12615637

  • 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.

    PubMed 34421801

  • 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.

    PubMed 32811464

  • 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. doi: 10.1016/s0966-6362(00)00081-3.

    PubMed 11154935

  • 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.

    PubMed 31932999

  • 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.

    PubMed 32323606

  • 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.

    PubMed 26223831

  • 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 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.

    PubMed 33467297

  • 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. doi: 10.1007/s00415-003-1097-x.

    PubMed 12883930

Questions about this trial

What is this clinical trial studying?

A study testing Nordic Walking (NWG), Free Walking (FWG) and Health Education (HEG) in people with Multiple Sclerosis, Chronic Progressive and Multiple Sclerosis, run by Leonardo A. Peyré-Tartaruga at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test Timed Up and Go (time frame: Change from baseline at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05385731, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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