Pedaling Exercises for Disability and Activity Limitations "PEDAL"

Terminated

Phase 1/2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Detailed feedback Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Detailed feedback
    Description: Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.
  • Basic feedback Behavioral
    Intervention Desc: Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.
    ARM 1: Kind: Experimental
    Label: Basic feedback
    Description: Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Walking speed three months No
Secondary Distance walked in 3 minutes three months No

Sponsors