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Treadmill Training and Quality of Life in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Treadmill walking training with additional body load

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring treadmill training, body load, quality of life, Parkinson's disease, Motor Symptoms

Eligibility Criteria

51 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Universidade Federal de São Carlos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00890669

First Posted

April 28, 2009

Last Updated

May 1, 2009

Sponsor

Universidade Federal de Sao Carlos

1. Study Identification

Unique Protocol Identification Number

NCT00890669

Brief Title

Treadmill Training and Quality of Life in Parkinson's Disease

Official Title

Treadmill Walking Training With Additional Body Load Improves Quality of Life in Subjects With Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Universidade Federal de Sao Carlos

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

treadmill training, body load, quality of life, Parkinson's disease, Motor Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PD Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Treadmill walking training with additional body load

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

51 Years

Maximum Age & Unit of Time

81 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadiesca T Filippin, MSc

Organizational Affiliation

Universidade Federal de Sao Carlos

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rosana Mattioli, PhD

Organizational Affiliation

Universidade Federal de Sao Carlos

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Paula H Lobo da Costa, PhD

Organizational Affiliation

Universidade Federal de Sao Carlos

Official's Role

Study Director

Facility Information:

Facility Name

Universidade Federal de São Carlos

City

São Carlos

State/Province

ZIP/Postal Code

13565-905

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Treadmill Training and Quality of Life in Parkinson's Disease

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