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Completed

NCT Number: NCT03355521

Effects of Nordic Walking in Parkinson Disease Patients

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).

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio Grande do Sul

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

nordic walking

Other

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. Free 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); (c) return to the calm and ultimate stretching.

Free walking

Other

Free walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free 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); (c) return to the calm and ultimate stretching.

Primary outcomes

  1. Test Timed Up and Go

    Time frame: Change from baseline at 9 weeks

    This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS)

Secondary outcomes

  1. Locomotor Rehabilitation Index

    Time frame: Change from baseline at 9 weeks

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

  2. Self-selected walking speed - SSWS

    Time frame: Change from baseline at 9 weeks

    This outcome will be measure in test of walking treadmill

  3. Optimal Walking Speed (OPT)

    Time frame: Change from baseline at 9 weeks

    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.

  4. Quality of life (QoL)

    Time frame: Change from baseline at 9 weeks

    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).

  5. Cognitive function

    Time frame: Change from baseline at 9 weeks

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

  6. Depressive symptoms

    Time frame: Change from baseline at 9 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 you feel that your life is empty?," Do you feel that your situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.

Other outcomes

  1. Motor symptoms

    Time frame: Change from baseline at 9 weeks

    This outcome will be evaluated using Unified Parkinson's Disease Rating Scale. This Scale the clinician-scored monitored motor evaluation. Will be to considered 30% improvement in the Part III score hasbeen applied to define "responders. The score in each item ranges from 0 to 4, and the indicates greater impairment by the disease and the minimum, normality.

    The 14 items in the motor vehicle (the numbering of which goes from 18 to 31).

  2. Balance Dynamics

    Time frame: Change from baseline at 9 weeks

    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.

  3. Balance Static

    Time frame: Change from baseline at 9 weeks

    This outcome will be evaluated using area of center of pressure (cm), with average velocity (IN cm/s) and root mean square (RMS). Assessments using unique measurements with force plat.

  4. Spatial Temporal Parameters

    Time frame: Change from baseline at 9 weeks

    This outcome is measure a composite for: stride frequency (in Hetz), stride length (in meters), swing time (in second) and contact time (in second). 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 kilometros/hours).

  5. Dynamics Stability

    Time frame: Change from baseline at 9 weeks

    This outcome will be evaluated using the coefficient of variation (CoV) of the Spatial Temporal Parameters: stride frequency (In Hertz), stride length (in meters), swing time (in seconds) and contact time(in seconds) 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. Anthropometric data

    Time frame: Change from baseline at 9 weeks

    This outcome is a composite for: circumferences (in cm), height (in meters), body massa (in kilograms) and body mass index - BMI (weight and height will be combined to report BMI in kg/m^2. This outcome will be measure with balance, stadiometer and anthropometric tape.

  7. Electromyographic Parameters

    Time frame: Change from baseline at 9 weeks

    This outcome is measure is a composite for: mean amplitude (in milivolts), onset (in seconds), offset (in seconds) and time of the signal and co-contraction (in seconds) 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.

  8. Parameters of Pendular Mechanism

    Time frame: Change from baseline at 9 weeks

    This outcome is measure a composite for:(external, internal and total mechanical work, Wext,Wint and Wtot, respectively, Recovery. 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.

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

  • Federal University of Health Science of Porto Alegre
  • Hospital de Clinicas de Porto Alegre

Registry information

Official study title

Effects of Nordic Walking Training on Functional, Clinical and Biomechanics Parameters in Parkinson's Disease: a Randomized Controlled Clinical Trial

Acronym: Walking

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 28, 2017
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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