MUSCLE - Nordic Walking in MUltiple SCLErosis

Leonardo A. Peyré-Tartaruga

Status: Not yet enrolling

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

Treatments: Other: Free Walking (FWG); Other: Nordic Walking (NWG); Other: Health Education (HEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT05385731

MUSCLE

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Nordic Walking (NWG)

Experimental group

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.

Treatment:

Other: Nordic Walking (NWG)

Other: Free Walking (FWG)

Other: Health Education (HEG)

Free walking (FWG)

Active Comparator group

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.

Treatment:

Other: Nordic Walking (NWG)

Other: Free Walking (FWG)

Other: Health Education (HEG)

Health Education (HEG)

No Intervention group

Description:

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