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Pedaling Exercises for Disability and Activity Limitations (PEDAL)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01391949
First received: July 11, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Stroke
 Behavioral: Detailed feedback
Behavioral: Basic feedback
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: UCFit Pedaling Exercises to Limit Disability in the Outpatient Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Walking speed [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distance walked in 3 minutes [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Detailed feedback
Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.
 Behavioral: 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.
Active Comparator: Basic feedback
Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise.
 Behavioral: Basic feedback
Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391949

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Andrew Dorsch, MD University of California, Los Angeles
Principal Investigator: Bruce Dobkin, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Andrew Dorsch MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01391949     History of Changes
Other Study ID Numbers: 11-001404
Study First Received: July 11, 2011
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
disability
walking
feedback
exercise

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013