NCT01901939

Brief Summary

The proposed preliminary study from this interdisciplinary team will provide important information about the feasibility and safety of bedside low intensity pedaling exercise during hospitalization. The findings from this study are essential to develop high-value, effective treatments that can be used by any hospital setting throughout the country. The program that investigators are proposing may provide important changes in how disability can be prevented in elderly patients who are hospitalized because of an acute illness.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

June 21, 2013

Last Update Submit

April 18, 2017

Conditions

Keywords

exerciseelderlyactivities of daily livingdisability

Outcome Measures

Primary Outcomes (1)

  • Activities of Daily Living

    Discharge is considered release from the hospital to home or other facility, indicating that their condition has been resolved or adequately treated or is stabilized during their hospital stay. On average we anticipate the time frame between hospital admission and discharge to be variable but between 3-5 days in length.

    Change from Baseline (Admission) to Discharge (approximately 3-5 days in length)

Secondary Outcomes (2)

  • Instrumental Activities of Daily Living

    Change from Baseline (Admission) to Discharge (approximately 3-5 days in length)

  • Short Physical Performance Battery

    Change from Baseline (Admission) to Discharge (approximately 3-5 days in length)

Study Arms (1)

exercise

EXPERIMENTAL

daily bedside tailored low intensity pedaling exercise

Other: exercise

Interventions

daily tailored low level pedaling exercise at bedside

exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • English speaking
  • age 65 years or older
  • Able to tolerate exercise
  • Non-elective admission to hospital

You may not qualify if:

  • Elective admission with expected LOS of 2 days or less
  • Diagnosed with Dementia or Alzheimer's disease
  • Lower extremity amputation
  • Delirium
  • Severe arthritis limiting ability to perform pedaling exercise
  • Uncontrolled hypertension
  • Hypotension
  • Non-English speaking
  • Participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto HCS

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Roberta K Oka, PhD, RN

    VA Palo Alto HCS

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Nurse for Research and Advanced Practice Nursing

Study Record Dates

First Submitted

June 21, 2013

First Posted

July 17, 2013

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations