Pedaling Exercises for Disability and Activity Limitations

Stroke Clinical Trial

— PEDAL  

Official title:

UCFit Pedaling Exercises to Limit Disability in the Outpatient Setting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01391949
• Other study ID #: 11-001404
• Status: Terminated
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: June 2015

Study information

• Verified date: May 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This purpose of this study is to determine the effect of different levels of feedback on participation in a home exercise regimen and the amount of walking performed by patients recently discharged from the acute rehabilitation setting.

Description:

The UCFit (University of California's U Cycle to Fitness) device is a standard commercial arm and leg restorator modified to collect pedaling data and to transmit it wirelessly to a central database, allowing for remote exercise monitoring. In this study, patients with stroke will perform pedaling exercise on the UCFit device prior to and then for a period of twelve weeks after discharge to home from inpatient rehabilitation. Differing levels of feedback will be provided to study subjects and corresponding changes in the amount of pedaling and walking performed will be identified. The results of this study will offer insight into the activity levels of disabled persons in their home environments. Furthermore, it will help in the identification of strategies that can increase activity levels in the critical period after discharge to home.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of stroke

• no major contraindications to participating in light-to-moderate exertion

• able to follow and retain verbal directions to carry out simple lower extremity repetitive exercises

• planned discharge to home with family available to assist

Exclusion Criteria:

• pre-morbid limitations in walking related to another medical disease

• body mass index >30

• fractures or contractures that prevent use of an extremity for pedaling

• impairment in cognition that precludes a full understanding of the risks and benefits of this study

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Detailed feedback
Once a week subjects will receive feedback about the total time spent cycling and walking in the previous week. Subjects in this intervention group will also receive feedback about average cycling speed, distance pedaled, average walking speed, and distance walked in the previous week.
• Basic feedback
Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed	Fastest safe walking speed over 10 meters	three months
Secondary	Distance walked in 3 minutes	Distance walked at fastest safe speed over 3 minutes	three months