Pedaling Exercises for Disability and Activity Limitations (PEDAL)

University of California, Los Angeles (UCLA)

Status and phase: Terminated; Phase 2

Conditions: Stroke

Treatments: Behavioral: Basic feedback; Behavioral: Detailed feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT01391949

11-001404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

7 participants in 2 patient groups

Detailed feedback

Experimental group

Description:

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

Treatment:

Behavioral: Detailed feedback

Basic feedback

Active Comparator group

Description:

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

Treatment:

Behavioral: Basic feedback