Feasibility of Telephone Counseling to Increase Physical Fitness in SCI (Co-Motion Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- The rate of enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •Body Mass Index (BMI) greater than
- •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
结局指标
主要结局
The rate of enrollment
时间窗: 1.5 years
The investigators will measure the enrollment rate as it pertains to the feasibility of the study procedures.
次要结局
- Number of Participants with Serious and Non-Serious Adverse Events(1.5 years)
- Cardiorespiratory Fitness (V02 Peak)(Baseline and 6 months post randomization)
- Call completion rate as it pertains to the feasibility of the study procedures(6 months post randomization)
- Study completion rate as it pertains to the feasibility of the study procedures(6 months post randomization)
- Total cholesterol to high density lipoprotein (TC:HDL) ratio as a cardiometabolic risk factor(Baseline and 6 months post randomization)
- Body Mass Index (BMI)(Baseline and 6 months post randomization)
- Minutes of moderate to vigorous physical activity as measured by the Physical Activity Recall Assessment for People with SCI (PARA-SCI)(Baseline and 6 months post randomization)
- Waist Circumference(Baseline and 6 months post randomization)
- Fat and lean body mass by dual energy x-ray absorotiometry (DXA)(Baseline and 6 months post randomization)
- Missing data rates as it pertains to the feasibility of the study procedures(1.5 years)
- Insulin Sensitivity Index (ISI) as a cardiometabolic risk factor(Baseline and 6 months post randomization)
- Low density lipoprotein to high density lipoprotein (LDL:HDL) ratio as a cardiometabolic risk factor(Baseline and 6 months post randomization)
研究者
Charles Bombardier
Professor of Rehabilitation Medicine
University of Washington