Pedaling Exercises for Disability and Activity Limitations

Study Overview
=================
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.

Official Title
-----------------
UCFit Pedaling Exercises to Limit Disability in the Outpatient Setting

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Detailed feedback
* Behavioral: Basic feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Detailed feedback<br>Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise. | Behavioral: Detailed feedback<br>* 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.<br>|
| Active Comparator: Basic feedback<br>Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise. | Behavioral: Basic feedback<br>* Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking speed | Fastest safe walking speed over 10 meters | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance walked in 3 minutes | Distance walked at fastest safe speed over 3 minutes | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disability, walking, feedback, exercise