Clinical trial NCT03355521: Effects of Nordic Walking in Parkinson Disease Patients
Official title: Effects of Nordic Walking Training on Functional, Clinical and Biomechanics Parameters in Parkinson's Disease: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Parkinson Disease 10
Keywords: functionality
gait
kinematics
electromyographic activity
depressive symptoms
quality of life
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Federal University of Health Science of Porto Alegre
name: Hospital de Clinicas de Porto Alegre
First posted: 2017-11-28
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental: Nordic walking Experimental: Nordic walking Training The total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Nordic walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW or NW); (c) return to the calm and ultimate stretching. The participants were trained with individualized prescription according to their maximum distance. A heart rate monitor, Model FT4 attached to the chest of the xiphoid process, was used to control the progression of intensity for the training cycles ranging from 60% to 80% of heart rate reserve. Additionally, we used the Borg RPE for training intensity control, which ranged between 13 and 17 of that scale.
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD.

Outcomes: Motor symptoms: Staging and severity of PD, balance, walking functional mobility, self-selected walking velocity, and rehabilitation index. Non-Motor symptoms: Cognitive function, depressive symptoms, and quality of life (QL). Outcomes Biomechanics: Kinematic parameters (spatiotemporal and dynamic stability of walking) and neuromuscular parameters (amplitude of the electromyography signal, initial and final activation threshold, activation time and co-contraction index, of the following muscles: Vastus Lateralis (VL), Biceps Femoris (BF), Tibialis Anterior (TA), Gastrocnemius Medialis (GM).

Detailed description: Introduction: Changes in clinical, functional and biomechanical parameters of gait are remarkable features in Parkinson's disease (PD). Such changes are disabling for the performance of daily living activities (DLAs) as they represent a high risk of falls and impair quality of life (QL) in this population. Although exercise is recommended as an effective model of therapeutic intervention, to minimize the symptoms of this disease, little is known about the effects of Nordic walking on motor and non-motor symptoms in patients with PD. Purpose: The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD. Experimental Design: Randomized controlled clinical trial (RCT). Study Site: Physical Education School of the Federal University of Rio Grande do Sul and the Clinical Hospital of Porto Alegre, in Porto Alegre, Rio Grande do Sul, Brazil. Methods: The sample comprised 33 participants, aged above 50 years, of both sexes, with a clinical diagnosis of idiopathic PD, with the staging of 1-4 in the Hoehn and Yahr scale (H\&Y). The participants received two types of intervention: Nordic walking training program (NW, n = 16) and free walking training program (FW, n = 17), during six weeks. Aiming to evaluate the effects of the training program, the participants underwent the tests in the following period: pre-training + pre-familiarization (T1); post-familiarization + pre-training (T2); post-training (T3).

Eligibility criteria: Inclusion Criteria: volunteers aged over 50 years, of both sexes, with a clinical diagnosis of idiopathic PD and staging between 1 and 4 in Hoehn and Yahr Scale (H\&Y).

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Exclusion Criteria:

* Show chronic pain or presence of a migraine or nausea in daily life;
* History of labyrinthitis;
* Deep Brain Stimulation (DBS);
* The frequency of training below of 75%.

Primary outcomes:
measure: Test Timed Up and Go
timeFrame: Change from baseline at 9 weeks
Secondary outcomes:
measure: Locomotor Rehabilitation Index
timeFrame: Change from baseline at 9 weeks
measure: Self-selected walking speed - SSWS
timeFrame: Change from baseline at 9 weeks
measure: Optimal Walking Speed (OPT)
timeFrame: Change from baseline at 9 weeks
measure: Quality of life (QoL)
timeFrame: Change from baseline at 9 weeks
measure: Cognitive function
timeFrame: Change from baseline at 9 weeks
measure: Depressive symptoms
timeFrame: Change from baseline at 9 weeks
Other outcomes:
measure: Motor symptoms
timeFrame: Change from baseline at 9 weeks
measure: Balance Dynamics
timeFrame: Change from baseline at 9 weeks
measure: Balance Static
timeFrame: Change from baseline at 9 weeks
measure: Spatial Temporal Parameters
timeFrame: Change from baseline at 9 weeks
measure: Dynamics Stability
timeFrame: Change from baseline at 9 weeks
measure: Anthropometric data
timeFrame: Change from baseline at 9 weeks
measure: Electromyographic Parameters
timeFrame: Change from baseline at 9 weeks
measure: Parameters of Pendular Mechanism
timeFrame: Change from baseline at 9 weeks
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Leonardo A Peyré-Tartaruga, PhD
role: STUDY_DIRECTOR
References:
citation: Monteiro EP, Franzoni LT, Cubillos DM, de Oliveira Fagundes A, Carvalho AR, Oliveira HB, Pantoja PD, Schuch FB, Rieder CR, Martinez FG, Peyre-Tartaruga LA. Effects of Nordic walking training on functional parameters in Parkinson's disease: a randomized controlled clinical trial. Scand J Med Sci Sports. 2017 Mar;27(3):351-358. doi: 10.1111/sms.12652. Epub 2016 Feb 2.