A Lifestyle Intervention Targeting Enhanced Health and Function for Persons With Chronic SCI in Caregiver/Care-Receiver Relationships: Effects of Caregiver Co-Treatment
Condition: Spinal Cord Injury; Cardiovascular Diseases; Obesity
MeSH terms: Spinal Cord Injuries; Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study determines in people with chronic SCI the health and functional impact and user
      acceptance and satisfaction - of a 6-month comprehensive Lifestyle Intervention; the impact
      and user acceptance/satisfaction of a Complementary Caregiver Curriculum (CCC) on SCI
      caregiver health and function and whether the complementary caregiver curriculum (CCC)
      enhances health and functional benefits obtained by the SCI dyadic partner enrolled in the LI
      program.
    

Detailed description: 
      The current proposal addresses the compelling problem of cardiometabolic disease risk and
      functional decline in persons with disability from spinal cord injuries and disease (SCI/D).
      'Obesity/overweight' addressed in this project - a major component of cardiometabolic disease
      risk (CMD) - represents the sole chronic condition whose speed of growth and widespread
      dispersion parallels pandemics of communicable diseases. Nearly 2/3 of Americans are
      currently overweight or obese, with a growth rate exceeding 10% in the past decade. The
      prevalence and impact of obesity is expected to worsen. Obesity-related health risks cross
      all lines of gender, geographic region, socioeconomic status, race, heritage, and educational
      level, and are strongly associated with comorbid conditions including: cardiometabolic
      syndrome, hypertension, diabetes, inflammatory disease, coronary artery disease, congestive
      heart failure, stroke, osteoarthritis, sleep apnea, depression, cancer, respiratory failure,
      disorders of coagulation, and degenerative joint disease. All of these disorders are widely
      reported at elevated prevalence in people with physical disability (PWPD). A study based on
      pooled data from the 1994-5 National Health Interview Survey, the 1994-5 Disability
      Supplement, and the 1995 'Healthy People 2000' Supplement reported a 66% higher rate of
      obesity among PWPD than the general population. A regional study reported that extreme
      obesity (body mass index [BMI] ≥ 40) was four times more prevalent among PWPD than those
      without. Prevalence rates for overweight and obesity in persons with chronic SCI/D are
      equally daunting, and range from 55% to 95.7% of the population. Numerous causes explain
      accretion of body fat after SCI including sarcopenia leading to loss of metabolically active
      muscle mass, reduced whole body energy expenditure, restricted choices for exercise
      conditioning, and a hypercaloric diet. Irrespective of cause, weight gain after disability
      brings about diminished work capacity, musculoskeletal decline, pain, accelerated
      cardiovascular diseases (CVD), and progressive life dissatisfaction. Overweight/obesity after
      SCI/D is also disturbingly co-morbid with dyslipidemia, glucose intolerance, and insulin
      resistance, a 'pro-inflammatory phenotype, and risks of postprandial lipemia. Increasing body
      mass (BM) promotes wheelchair injury and dysfunction, imposes significant burdens on
      self-image and perceived health, and is far more difficult to reverse than obesity occurring
      in persons without disability. Overweight in particular: a) Poses functional limitations, and
      restricts physical activity, independence, and community integration; b) affects ease of
      transferring, joint function, and fracture risk; and, c) compromises 'activities of daily
      living' (ADLs) in 39% of individuals with SCI. Despite all of these risks and concerns an
      effective solution to this problem has evaded researchers, clinicians, and stakeholders with
      SCI.

      While an overweight body has implications for health and function of PWPD, it also has an
      impact on their caregivers. Within the past quarter decade there has been a predictable shift
      of many health and function related responsibilities to adjuvant providers (i.e., healthcare
      provider extenders) -- so-called 'caregivers' - who are challenged to administer greater
      health and functional demands of aging PWPD while they are similarly experiencing health and
      functional 3 decline accompanying their own aging. This shifting of providers will likely
      continue, or possibly worsen due to an uncertain future of disability coverage within a
      tentative American health system. The investigators have already started to observe - yet not
      fully comprehend - the many complex difficulties imposed by aging on PWPD and their
      caregivers, and speculate how to effectively intervene on them. Unlike caregivers for persons
      with Alzheimer's disease and Parkinson's disease, caregivers of people with wheelchair
      dependency are required to be more physically active, lift/push/roll an impaired body far
      more often, and often assume caregiving responsibilities earlier in the life of PWPD. While
      clinicians and researchers often focus on the person with disability, their caregiver can be
      left out of the care plan. It is thus not surprising that pain, anxiety, and depression among
      caregivers of PWPD is exceedingly prevalent.

      Encouraging evidence already suggests an important role for primary and secondary lifestyle
      intervention (LI) in the form of weight-lessening and fitness-promoting nutrition and
      exercise to improve health and function of people aging with disability. Comprehensive LI
      programs of exercise, nutrition, and behavioral support for people without disabilities have
      been designed and systematically tested in multi-center clinical trials, and have been found
      effective in the short term for promoting weight loss and lessening conversion rates to frank
      diabetes. The LI programs have been compared against pharmacotherapy and have actually been
      found more effective. Programmatic modifications made for community deployment of the LI
      plans, and testing of long-term follow-up have shown remarkable success in sustaining - or
      even further improving - benefits obtained during initial treatment. These research findings
      make LI programs of weight-loss promoting reconditioning exercise, nutrition, and behavioral
      support legitimate candidates for testing in PWPD, although no studies have ever done so.
      Moreover, the impact of these interventions on caregiver burden has never been examined,
      although it is reasonable to conjecture that loss of body BM and improved fitness/function of
      care-receivers would reduce global caregiver burden. Further, evidence supports lifestyle and
      health benefits to the care-receiver when a caregiver is enrolled in a linked behavioral
      intervention program, making the relationship of the dyadic partners in benefiting one
      another through coordinated intervention an intriguing intervention benefit.

      To: a) address the concerning problem of overweight/obesity after SCI, b) better understand
      its impact on health and function of persons with SCI and their caregivers, and c) intervene
      on these hazards where inaction would forecast additional decline, the investigators will
      conduct a randomized, controlled, multi-center intervention study examining persons with
      disability from SCI and their caregivers, who will together be enrolled as dyadic partners.
      Key questions will address whether: a) people with disability from SCI benefit from the LI
      plan through improved health and function, b) caregivers of people with disability from SCI
      benefit from the LI plan through their own improved health and function, c) co-participation
      of a caregiver partner in a LI curriculum provides a cross benefit for their partner, and d)
      benefits of clinical intervention are long-lasting with minimal supervision. The
      investigators will use an intervention for all participants with SCI that is modeled after
      the Diabetes Prevention Program (DPP) that incorporates population-appropriate exercise,
      nutrition, and behavioral support. Caregivers (linked with their partners) will be randomized
      to either 'behavioral support' or a 'control condition'. Clinical training will take place
      for 6 months and then be followed by a 6-month minimally supervised extension phase. Outcomes
      tested for participants with SCI will focus on domains of health and function reflected by
      fitness, cardioendocrine risk and inflammatory stress; multi-dimensional function and pain;
      Sol and independence; and self-efficacy, program acceptance, and life satisfaction. Outcomes
      tested for caregivers will focus on multidimensional function and pain; and, Quality of Life
      (QoL) and independence, the latter including perceived caregiver burden.
    

Intervention name(s): Spinal Cord Injury (SCI); Caregiver Intervention(CCC); Caregiver Control (CC)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The SCI Intervention group will undergo intense exercise, a defined nutrition program, and an educational program taught by the study investigators. The exercise will require them to undergo supervised activity 3 times weekly for 6 months. They will also participate in a series of educational sessions that examine their lifestyle, and modify exercise/nutritional habits. After 6 months they will advance to another 6 months or "extension phase" in which the investigators expect them to continue to exercise up to 3 times per week at our center or at home by using elastic exercise bands (Thera-band) and handles that the Investigators will provide and teach how to use. They will also be expected to continue the modified nutritional program.; The Caregiver Intervention group will undergo intense exercise, a defined nutrition program, and an educational program taught by the study investigators. The exercise will require them to undergo supervised activity 3 times weekly for 6 months. They will also participate in a series of educational sessions that examine their lifestyle, and modify exercise/nutritional habits. After 6 months they will advance to another 6 months or "extension phase" in which the investigators expect them to continue to exercise up to 3 times per week at our center or at home by using elastic exercise bands (Thera-band) and handles that the Investigators will provide and teach how to use. They will also be expected to continue the modified nutritional program.; The Caregiver Control group will also discuss ways in which health and fitness can be improved through exercise and nutrition and will also be offered a fully paid membership to the an exercise fitness center to encourage them to exercise and consume a healthy diet. Unlike the Caregiver Intervention group(CCC) the lifestyle recommendations will be provided by internet authorities such as Web Medical(WebMD), the US Department of Agriculture, and the US Department of Human Health Services, which are dependable websites that promote healthy ways of living.
Other intervention name(s): Lifestyle program-SCI; Lifestyle program-Caregiver Intervention CCC; CC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; disability; obesity; cardiometabolic; Caregiver