Role of Exercise in Reversal of Hospitalization-associated Disability in Elderly

The study design includes 2 phases (10 months each) for development and evaluation of the
testing and intervention protocol. The last 4 months of the study will be devoted to
preparation of a larger randomized controlled clinical trial grant submission. Mixed methods
will be used in both phases.

Phase I will focus on developing, testing and refining the measurement protocol and bedside
tailored low intensity pedaling exercise (Ex) program using mixed methods. During this
10-month phase, researchers plan to enroll 10 participants who are admitted to a medical
surgical (MS) unit and meet study eligibility criteria. Investigators will implement our
proposed testing and intervention protocol,obtain feedback and make modifications as
necessary. For this purpose the study team will use a process improvement framework with
rapid cycle improvements. The outcome for Phase I will be development of a manual of
operations for the testing and Ex protocol that will be implemented in Phase II.

Phase II (10 months) will randomly assign 60 patients over the age of 65 years who meet
medical criteria and are admitted to a medical surgical (MS) hospital unit at the VA Palo
Alto Health care system (VAPA HCS) to one of two groups, 1) low intensity bedside pedaling
exercise or 2) usual care. All participants will be asked to complete questionnaires,
undergo a Short Physical Performance Battery (SPPB), cognitive testing and a blood draw
prior to participation in the Ex program (baseline). All testing and blood draw will be
repeated within 24 hours prior to discharge (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) from the hospital(approximately at 5-6 days).
Participants will be followed for the duration of the hospital stay, an expected average
length of 5-6 days. Additionally, all participants will be asked to continue to exercise
after discharge to home for 4 weeks. All tests will be performed at baseline (prior to
intervention), within 24 hours prior to discharge (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)from the hospital, on average 5-6 days) and again
at 4 weeks post discharge. The focus of Phase II is safety and feasibility of the
intervention and association with outcome measures. The length of stay (LOS) at VAPA HCS is
approximately 6 days. Thus, the study investigators anticipate that each individual will be
enrolled approximately 5 days and participate in an average of 8 training sessions.
Investigators will also examine the association between physical activity levels at baseline
(pre Ex) and myokines and associated changes in myokines after intervention.

A description of the Ex program:

Individually tailored, low intensity bedside pedaling exercise:

Once participants complete the testing protocol they will be instructed in the bedside Ex
program. Exercise intensity and duration will be individualized to the subject's physical
limitations and tolerance. The PI is an Adult Nurse Practitioner (ANP), and will supervise
and monitor exercise response including Heart Rate (HR), Blood Pressure (BP), Rating of
Perceived Exertion (RPE), and symptoms (intensity, duration). Exercise will be terminated
according to the American College of Sports Medicine (ACSM) criteria. Ex will consist of
progressively increased pedaling exercise performed initially for one-two minutes, three
times or more daily as tolerated. Pedaling exercise will be progressively increased as
tolerated and appropriate. Cycle ergometry has been shown to be an effective exercise
modality to maintain muscle strength and aerobic capacity in a variety of age groups. While
inpatient exercise prescriptions utilize walking as the primary mode of exercise, recent
studies show that despite known benefits of ambulation, multiple barriers prevent routine
implementation in practice settings. The study investigators propose to examine the
feasibility of a portable bedside pedaling device for exercise. This modality eliminates
dependence on hospital staff to supervise ambulation and allows patients greater access to
optimal treatment recommendations to maintain functional independence. This exercise
modality is not new, but bedside use is novel. The pedaling device is sturdy and portable
and will be placed at the foot of an anchored chair. Subjects will be able to pedal without
fear of falling or interference from other devices. This exercise will be performed in
addition to their normal ambulation requirements. All catheters and other devices will be
secured so that accidental removal will not occur during the Ex session.

Adherence is a key component of this study and will be monitored during both phases of the
pilot study. Adherence will be assessed by direct observation from PI/staff. Investigators
will also examine potential barriers and facilitators to exercise training adherence by
obtaining qualitative feedback from study participants. The qualitative information will
provide greater depth of understanding to improve the delivery of the intervention as well
as assist in optimizing adherence.

The Study team will also ask participants if they are willing to be contacted regarding
future research that may be of interest to them.

Inclusion Criteria:

- English speaking

- age 65 years or older

- Able to tolerate exercise

- Non-elective admission to hospital

Exclusion Criteria:

- 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