Feasibility of Telephone Counseling to Increase Physical Fitness in SCI
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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.
    

Intervention name(s): Physical Activity Counseling
Intervention type(s): Behavioral
Intervention description(s): Participants in the physical activity counseling group will be mailed a home exercise toolkit that may include an activity monitor, exercise resistance bands, and exercise DVDs made for people with paraplegia or tetraplegia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
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