NCT00890669

Brief Summary

Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of life of the subjects. The purpose was to assess the effects of treadmill walking training with additional body load on the quality of life and motor symptoms of the subjects with PD. Methods: Nine subjects with PD, Hoehn and Yahr stages 2 through 3, not demented and with capability to ambulate independently voluntarily participate in this study. The training program was divided into three phases (A1-B-A2): treadmill training with additional body load (A1), control condition (conventional physical therapy group) (B) and treadmill training with load again (A2). Each phase lasted six weeks. The quality of life and motor symptoms were assessed by PDQ-39 and UPDRS, respectively. Both evaluations and training were performed during on-phase of the medication cycle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
Last Updated

May 4, 2009

Status Verified

May 1, 2009

First QC Date

April 28, 2009

Last Update Submit

May 1, 2009

Conditions

Keywords

treadmill trainingbody loadquality of lifeParkinson's diseaseMotor Symptoms

Outcome Measures

Primary Outcomes (1)

  • The quality of life was measured through Parkinson Disease Questionnaire (PDQ-39).

    4 times, once before treatment, and 3 after each treatment phase.

Study Arms (1)

PD Group

EXPERIMENTAL

Nine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study.

Other: Treadmill walking training with additional body load

Interventions

The training program was divided into three phases (A1-B-A2): * treadmill training with additional body load (A1), * control condition (conventional physical therapy group) (B). and * treadmill training with additional body load again (A2). Each phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle.

PD Group

Eligibility Criteria

Age51 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hoehn and Yahr (H-Y) stages 2 through 3
  • Absence of dementia (Mini-Mental Status Examination - MMSE, defined according to educational level)
  • Capacity to ambulate independently for at least 10 meters

You may not qualify if:

  • Change medication (dopaminergic) during the study period
  • Use treadmill for at least six months prior to the study
  • Other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the accomplishment of the training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Nadiesca T Filippin, MSc

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR
  • Rosana Mattioli, PhD

    Universidade Federal de Sao Carlos

    STUDY CHAIR
  • Paula H Lobo da Costa, PhD

    Universidade Federal de Sao Carlos

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 30, 2009

Study Start

August 1, 2007

Study Completion

December 1, 2008

Last Updated

May 4, 2009

Record last verified: 2009-05

Locations