Clinical trial NCT02225028: Feasibility of Telephone Counseling to Increase Physical Fitness in SCI
Official title: Feasibility of Telephone Counseling to Increase Physical Fitness in SCI (Co-Motion Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: physical activity
physical fitness
exercise program
telephone coaching
motivational counseling
stretching
fitness improvement
exercise coaching
toning
SCI
spinal cord injury
home-based
home exercise
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2014-08-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People with spinal cord injuries (SCI) are among the least physically active groups in our society. Approximately 1 in 4 healthy young persons with spinal cord injury (SCI) does not have sufficient fitness to perform many essential activities of daily living. About 50% of people with SCI engage in no leisure time physical activity. That is, they do not wheel or walk for pleasure, don't play a sport, don't exercise at home or go to a gym. As a result of this, cardiovascular, endocrine and metabolic conditions adversely affect the health of a large segment of the SCI population. Fortunately, clinic and/or laboratory-based aerobic conditioning and circuit training studies provide compelling evidence that people with SCI can improve their cardiorespiratory fitness and by doing so can partially reverse cardiovascular disease (CVD) risk factors, enhance Quality of Life (QOL) and improve elements of subjective well-being. While intensive, clinic-based, supervised exercise programs can improve the fitness and health of persons with SCI, the value of these findings for the SCI population is limited because the vast majority of people do not have access to these specialized programs and facilities. The gap that the present study addresses is: How can we extend the benefits of increased exercise and physical activity to more people with SCI?

The goal of this study is to evaluate the feasibility of an individually tailored, home- or community-based, telephone delivered intervention that uses evidence-based behavioral and motivational counseling to increase daily physical activity and exercise.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of enrollment
timeFrame: 1.5 years
Secondary outcomes:
measure: Study completion rate as it pertains to the feasibility of the study procedures
timeFrame: 6 months post randomization
measure: Call completion rate as it pertains to the feasibility of the study procedures
timeFrame: 6 months post randomization
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: 1.5 years
measure: Missing data rates as it pertains to the feasibility of the study procedures
timeFrame: 1.5 years
measure: Cardiorespiratory Fitness (V02 Peak)
timeFrame: Baseline and 6 months post randomization
measure: Minutes of moderate to vigorous physical activity as measured by the Physical Activity Recall Assessment for People with SCI (PARA-SCI)
timeFrame: Baseline and 6 months post randomization
measure: Insulin Sensitivity Index (ISI) as a cardiometabolic risk factor
timeFrame: Baseline and 6 months post randomization
measure: Total cholesterol to high density lipoprotein (TC:HDL) ratio as a cardiometabolic risk factor
timeFrame: Baseline and 6 months post randomization
measure: Low density lipoprotein to high density lipoprotein (LDL:HDL) ratio as a cardiometabolic risk factor
timeFrame: Baseline and 6 months post randomization
measure: Body Mass Index (BMI)
timeFrame: Baseline and 6 months post randomization
measure: Waist Circumference
timeFrame: Baseline and 6 months post randomization
measure: Fat and lean body mass by dual energy x-ray absorotiometry (DXA)
timeFrame: Baseline and 6 months post randomization
Other outcomes:
measure: Participant-reported changes in Pain
timeFrame: Baseline and 6 months post randomization
measure: Participant-reported changes in Quality of Life
timeFrame: Baseline and 6 months post randomization
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Charles H Bombardier, PhD
role: PRINCIPAL_INVESTIGATOR
References: