NCT06342271

Brief Summary

People with Parkinson's Disease(PD) present a series of alterations such as muscle stiffness and motor slowing, which gradually affect the swinging movement of the arms and legs, altering the ability to walk, increasing the risk of falling, and reducing functionality. This implies a higher energy cost and a greater probability of developing freezing of the gait. Nordic walking (NW) is a form of physical exercise characterized by the use of walking poles, which could contribute positively to arm swing movement and, thus, gait. This clinical trial aims to compare Nordic Walking with free walking (FW) protocol training and investigate their effects on arm swing and gait parameters in people with PD. The study hypothesizes that NW training will reduce asymmetry and increase arm swing amplitudes during gait to a greater extent than FW. Also, improvements in arm swing could positively influence lower limb performance during regular gait, increasing gait speed, stride length, functional mobility, and quality of life. People with PD will complete 24 supervised NW or FW training sessions for 12 weeks. Both trainings will be identical in volume and intensity, the only difference will be the use of poles in the NW group. Blinded researchers will conduct evaluations at baseline (T0), post-intervention (T1), and in one-month follow-up (T2).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

March 26, 2024

Last Update Submit

March 26, 2024

Conditions

Keywords

Parkinson diseaseArms swingGaitGait Disorders, NeurologicNordic WalkingRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Change in the amplitude of arm swing

    It is the movement of the arms in the antero-posterior direction during walking. Measurements will be made through accelerometers, and the unit of measurement will be degrees.

    Before, after 12-weeks of training, and after one-month of follow-up.

  • Change in the arm swing asymmetry

    Asymmetry of the amplitude of movement between left and right swings during walking (0% means no asymmetry) \[%\]

    Before, after 12-weeks of training, and after one-month of follow-up.

Secondary Outcomes (3)

  • Change in the temporospatial measurements during walking including measurements of Gait speed [m/s] and step length [m].

    Before, after 12-weeks of training, and after one-month of follow-up.

  • Change in the functional mobility will be measured through the Timed up and go (TUG).

    Before, after 12-weeks of training, and after one-month of follow-up.

  • Change in the quality of life

    Before, after 12-weeks and after one-month of follow-up.

Study Arms (2)

Nordic Walking group

EXPERIMENTAL

The group will be training with a Nordic Walking protocol for 12- weeks, two times a week, completing 24 one-hour sessions.

Other: Nordic walking training

Free Walking group

ACTIVE COMPARATOR

The group will be training with a Free Walking protocol for 12- weeks, two times a week, completing 24 one-hour sessions.

Other: Free Walking training

Interventions

Participants will receive Nordic walking training (to walk with poles) for 12 weeks, 3x/week.

Nordic Walking group

Participants will receive Free walking training (to walk without poles) for 12 weeks, 3x/week.

Free Walking group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of idiopathic PD, confirmed by a neurologist following the criteria of the Parkinson disease Society Brain Bank Criteria
  • Age between 50-80 years
  • Disease stage between I and III according to Hoehn and Yahr (Hoehn and Yahr)
  • To be able to walk without technical aids.

You may not qualify if:

  • Cognitive impairment (score \< 26 in the Montreal Cognitive Assessment MoCA).
  • Surgery lasting less than three months or deep brain stimulation (DBS).
  • Presence of comorbidities that contraindicate moderate to high-intensity physical exercise.
  • Participate in any walking training two or more times per week.
  • Diagnosis of any other neurological or musculoskeletal condition that can cause motor compromise and interfere with locomotion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Espinoza-Araneda J, Caparros-Manosalva C, da Cunha M, Marzuca-Nassr GN, Fritz-Silva N, Pagnussat AS. Nordic walking and arm swing asymmetry in people with Parkinson's disease: protocol for a randomised clinical trial. BMJ Open Sport Exerc Med. 2024 May 27;10(2):e002029. doi: 10.1136/bmjsem-2024-002029. eCollection 2024.

MeSH Terms

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jéssica Espinoza, PT, MsC, PhD

    University of Talca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Espinoza, PT, MsC, PhD

CONTACT

Cristian Caparrós Manosalva, PT, MsC, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

June 1, 2024

Primary Completion

March 30, 2025

Study Completion

June 30, 2025

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share