Feasibility of Telephone Counseling to Increase Physical Fitness in SCI

The study is a randomized controlled trial comparing a 16 session telephone intervention
aiming to increase physical activity to usual care.

Participants who agree to join the study and meet all eligibility criteria will be asked to
do for following things in the course of 6 months.

BASELINE ASSESSMENT (Part 1 and 2):

For all participants who meet all screening eligibility criteria, a two-part baseline
assessment will be scheduled at the University of Washington Medical Center Clinical
Research Center.

During Part 1 of this visit, participants will complete an interview, medical tests and
receive a DXA scan. After completing Part 1 of the baseline, participants will be given an
activity monitor to wear at home for up to one week.

Approximately seven days after completing Part 1 of the baseline, participants will complete
Part 2. Part 2 consists of a cardiorespiratory fitness test. A healthcare monitor will be
available throughout testing to help ensure safety.

POST BASELINE FOLLOW-UP:

There are 3 possible outcomes following the baseline assessment.

1. Individuals may not be eligible for the study because of a medical condition that needs
treatment (for example, diabetes or hypertension).

Individuals who qualify for the study will be randomized (like flipping a coin) to
either a usual care group or the physical activity intervention group. Participants
have an equal chance of ending up in either group.

2. Participants may be randomized into the usual care group and receive no physical
activity coaching by telephone.

3. Participants may be randomized into the physical activity coaching intervention group.
The physical activity coach will contact participants within one week to begin the 6
month intervention.

2 AND 4 MONTH ASSESSMENT (10 minutes):

All participants, regardless of group assignment, will be asked to complete telephone
interviews with the research team two and four months after completing the baseline.
Interviews will consist of questions regarding physical activity levels and barriers related
to exercise.

6-MONTH OUTCOME ASSESSMENT (Part 1 and 2):

After six months, all participants will be asked to return to the University of Washington
Medical Center Clinical Research Center to complete the 6-month outcome assessment. The
6-month outcome assessment will be identical to the baseline assessment.

During Part 1 of this visit, participants will complete an interview, medical tests and a
DXA scan. After completing Part 1 of the 6-month outcome assessment, participants will be
given an activity monitor to wear at home for up to one week.

Approximately seven days after completing Part 1 of the 6-month outcome assessment,
participants will complete Part 2. During Part 2 of the visit, participants will undergo a
cardiorespiratory fitness test. A healthcare monitor will be available throughout testing to
help ensure safety.

Inclusion Criteria:

- English as primary language.

- History of traumatic SCI (C6 or below/ ASIA A-D) and uses a manual wheelchair at
least 50% of the time.

- Injured at least one year prior to enrollment.

- Reports less than 150 minutes per week of moderate to vigorous physical activity.

- Presence of two or more cardiometabolic risk factors:

1. Body Mass Index (BMI) greater than 21.

2. Fasting high density lipoprotein cholesterol (HDL) greater than or equal to 40
mg/dL.

3. Fasting triglycerides less than or equal to 150 mg/dL.

4. Fasting glucose greater than or equal to 100 mg/dL.

5. Blood pressure of 120-139 (systolic) / 80-89 (diastolic).

- Physician approval to initiate physical activity program.

Exclusion Criteria:

- Body Mass Index (BMI) greater than 40.

- Medically diagnosed ischemic heart disease; unstable angina, dysrhythmia or unstable
autonomic dysreflexia; recent osteoporotic fracture, tracheostomy.

- Medically diagnosed hyperlipidemia: on lipid lowering medication or detected during
baseline lipid panel.

- Medically diagnosed hypertension: on antihypertensive medication or hyertension
detected during secondary screening/baseline exam.

- Engaged in a structured exercise program within 6 month of enrollment.

- Engaged in a structured diet program.

- Presence of conditions that would preclude participation in home-physical activity
program such as: pressure ulcer, current substance dependence, psychosis, severe
chronic upper extremity pain, surgery pending within 6 months, current infection or
illness requiring hospitalization, or participation in another research study.

- Electrocardiographic abnormalities detected during any exercise test: 2o or 3o AV
block, pre-excitation arrhythmia, hemi-blocks, S-T segment depression (horizontal,
down sloping, or up sloping) diagnostic of myocardial ischemia, or other restrictions
(ACSM Guidelines 7th Edition).

- Current use of the following medications: Lipid lowering agents (e.g., statins,
fibric acid derivatives, niacins, bile-acid sequestrates, or cholesterol uptake
blockers), antihyperglycemics (biguanides, sulfonyureas, incretins, TZDs), herbal
medicines and hyper-vitamins having antilipemic or antihyperglycemic properties,
antihypertensives (Carbonic Anhydrase Inhibitors, thiazides, or loop diuretics), and
estrogen replacement therapy.

- Anticipated reasons subjects may be discharged from the trial and/or referred for
medical therapy (if indicated): At the 6 month assessment subject laboratory values
indicate they require medical treatment for diabetes, hyperlipidemia or hypertension;
pregnancy; pressure ulcer that affects the safety of performing physical activity.
NCEP ATP Guidelines will serve as the criterion for need for lipid intervention, ADA
guidelines for diabetes, and JNC VII Guidelines for Hypertension