Pedaling Exercises for Disability and Activity Limitations

Phase 2

Terminated

• Conditions: Stroke
• Interventions: Behavioral: Basic feedback; Behavioral: Detailed feedback

• Registration Number: NCT01391949
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basic feedback	Basic feedback	Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.
Detailed feedback	Detailed feedback	Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.

Primary Outcome Measures

Name	Time	Method
Walking speed	three months	Fastest safe walking speed over 10 meters

Secondary Outcome Measures

Name	Time	Method
Distance walked in 3 minutes	three months	Distance walked at fastest safe speed over 3 minutes

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States