Treadmill Training and Quality of Life in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890669
• Other study ID #: 234/07
• Secondary ID: CEP/UFSCar
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: May 1, 2009
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years to 81 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Treadmill walking training with additional body load
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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos	São Carlos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quality of life was measured through Parkinson Disease Questionnaire (PDQ-39).		4 times, once before treatment, and 3 after each treatment phase.	No