Pedaling Exercises for Disability and Activity Limitations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Detailed feedback

Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.

Group Type EXPERIMENTAL

Detailed feedback

Intervention Type BEHAVIORAL

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

Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.

Group Type ACTIVE_COMPARATOR

Basic feedback

Intervention Type BEHAVIORAL

Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.

Interventions

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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.

Intervention Type BEHAVIORAL

Basic feedback

Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No