Feasibility of Telephone Counseling to Increase Physical Fitness in SCI

NCT02225028 | Completed

• 2 other identifiers: 47327-B290122
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• The rate of enrollment

  The investigators will measure the enrollment rate as it pertains to the feasibility of the study procedures.

  1.5 years

Secondary Outcomes (12)

• Study completion rate as it pertains to the feasibility of the study procedures

  6 months post randomization

• Call completion rate as it pertains to the feasibility of the study procedures

  6 months post randomization

• Number of Participants with Serious and Non-Serious Adverse Events

  1.5 years

• Missing data rates as it pertains to the feasibility of the study procedures

  1.5 years

• Cardiorespiratory Fitness (V02 Peak)

  Baseline and 6 months post randomization

Other Outcomes (2)

• Participant-reported changes in Pain

  Baseline and 6 months post randomization

• Participant-reported changes in Quality of Life

  Baseline and 6 months post randomization

Study Arms (2)

Physical Activity Counseling

ACTIVE COMPARATOR

Participants who are randomized to the physical activity counseling intervention group will work with a physical activity coach over the course of 6 months to come up with a physical activity program that works for each individual. Participants will have 16 phone calls and discuss goals and values, track physical activity, troubleshoot barriers, and work on keeping exercise interesting and motivating. Participants will also learn strategies for managing stress and battling unhelpful thoughts that may get in the way of activity. By the end of the intervention, the goal is to be regularly doing 150 minutes of physical activity each week. The physical activity coach will work with participants to ensure that they are increasing activity safely in order to prevent injuries.

Behavioral: Physical Activity Counseling

Usual Care

NO INTERVENTION

Participants randomized to the usual care control group will receive a packet of exercise related-information at the end of the baseline assessment as well as a letter from study staff informing them of their randomization status and their test results. The letter will provide information on biological markers that are in the at-risk range, advice to seek medical advice regarding lifestyle changes such as diet and exercise and information on how to contact study staff regarding test results. We will offer to forward test results to their health care provider provided they furnish written release of information We will emphasize our interest in providing them with a follow-up assessment in 6 months.

Interventions

Physical Activity Counseling BEHAVIORAL

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.

Physical Activity Counseling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Body Mass Index (BMI) greater than 21.
• Fasting high density lipoprotein cholesterol (HDL) greater than or equal to 40 mg/dL.
• Fasting triglycerides less than or equal to 150 mg/dL.
• Fasting glucose greater than or equal to 100 mg/dL.
• Blood pressure of 120-139 (systolic) / 80-89 (diastolic).
• Physician approval to initiate physical activity program.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (2)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Charles H Bombardier, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rehabilitation Medicine

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 25, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

US (2)