NCT03355521

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2014

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

November 10, 2017

Last Update Submit

November 21, 2017

Conditions

Keywords

functionalitygaitkinematicselectromyographic activitydepressive symptomsquality of life

Outcome Measures

Primary Outcomes (1)

  • Test Timed Up and Go

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

    Change from baseline at 9 weeks

Secondary Outcomes (6)

  • Locomotor Rehabilitation Index

    Change from baseline at 9 weeks

  • Self-selected walking speed - SSWS

    Change from baseline at 9 weeks

  • Optimal Walking Speed (OPT)

    Change from baseline at 9 weeks

  • Quality of life (QoL)

    Change from baseline at 9 weeks

  • Cognitive function

    Change from baseline at 9 weeks

  • +1 more secondary outcomes

Other Outcomes (8)

  • Motor symptoms

    Change from baseline at 9 weeks

  • Balance Dynamics

    Change from baseline at 9 weeks

  • Balance Static

    Change from baseline at 9 weeks

  • +5 more other outcomes

Study Arms (2)

Nordic walking Experimental

EXPERIMENTAL

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

Other: Nordic WalkingOther: Free Walking

Free walking

ACTIVE COMPARATOR

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.

Other: Nordic WalkingOther: Free Walking

Interventions

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 walkingNordic walking Experimental

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.

Free walkingNordic walking Experimental

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Sul

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

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Parkinson DiseaseParkinson Disease 10Depression

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Leonardo A Peyré-Tartaruga, PhD

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 28, 2017

Study Start

March 20, 2013

Primary Completion

June 30, 2013

Study Completion

July 30, 2014

Last Updated

November 28, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations